title: Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study

summary:
One third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery.

Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit of targeted therapies), but are carriers of potentially significant side effects and are very expensive. The treatment response is considered on imaging exams repetitive, costly and inconsistently reliable. A serum marker of tumor development would be particularly welcome.

CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy.

In previous studies, the investigators tried to use CA9 to improve the differential diagnosis of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery and that this expression disappeared after tumor ablation.

ReferenceCitation: Li G, Feng G, Gentil-Perret A, Genin C, Tostain J. Serum carbonic anhydrase 9 level is associated with postoperative recurrence of conventional renal cell cancer. J Urol. 2008 Aug;180(2):510-3; discussion 513-4. doi: 10.1016/j.juro.2008.04.024. Epub 2008 Jun 11.

location_facility:
Centre Jean Perrin
CHU de Saint-Etienne
Institut Cancérologique de la Loire


title: Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.

summary:
Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.

The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.

Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib

acronym: DIPROCOL

summary: Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Hospitalier Régional
Centre Hospitalier Regional
Centre Oscar Lambret

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomized Controlled Trial Assessing the Impact of Routine "Oncologist-supportive Care Team" Consultation on the Use of an Additional Line of Chemotherapy in Metastatic Breast Cancer Patients

summary:
The purpose of this study is to assess the impact of systematic "clinical cancer department/supportive care department" consultation meetings, versus standard care, on the prescription of an additional line of chemotherapy in patients with metastatic breast cancer and visceral involvement after 3 or 4 lines of chemotherapy.

This is a prospective paucicentric open label randomized controlled study with 2 parallel arms.

Eligible patients will be randomly assigned to either arm "Study group" or "Standard care".

The number of patients required to demonstrate a 30% reduction of the number of prescriptions for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50 in each arm).

design_allocation: Randomized

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50.

ReferenceCitation: Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92.

ReferenceCitation: Giordano SH, Buzdar AU, Smith TL, Kau SW, Yang Y, Hortobagyi GN. Is breast cancer survival improving? Cancer. 2004 Jan 1;100(1):44-52.

ReferenceCitation: Banerji U, Kuciejewska A, Ashley S, Walsh G, O'Brien M, Johnston S, Smith I. Factors determining outcome after third line chemotherapy for metastatic breast cancer. Breast. 2007 Aug;16(4):359-66. Epub 2007 May 16.

ReferenceCitation: Rha SY, Moon YH, Jeung HC, Kim YT, Sohn JH, Yang WI, Suh CO, Kim GE, Roh JK, Chung HC. Gemcitabine monotherapy as salvage chemotherapy in heavily pretreated metastatic breast cancer. Breast Cancer Res Treat. 2005 Apr;90(3):215-21.

ReferenceCitation: Dufresne A, Pivot X, Tournigand C, Facchini T, Altweegg T, Chaigneau L, De Gramont A. Impact of chemotherapy beyond the first line in patients with metastatic breast cancer. Breast Cancer Res Treat. 2008 Jan;107(2):275-9. Epub 2007 Mar 23.

ReferenceCitation: Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Role of health-related quality of life in palliative chemotherapy treatment decisions. J Clin Oncol. 2002 Feb 15;20(4):1056-62.

ReferenceCitation: Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, Kussin P, Dawson NV, Connors AF Jr, Lynn J, Phillips RS. Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA. 1998 Jun 3;279(21):1709-14. Erratum in: JAMA 2000 Jan 12;283(2):203.

ReferenceCitation: Slevin ML, Stubbs L, Plant HJ, Wilson P, Gregory WM, Armes PJ, Downer SM. Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public. BMJ. 1990 Jun 2;300(6737):1458-60.

ReferenceCitation: Glare P, Virik K, Jones M, Hudson M, Eychmuller S, Simes J, Christakis N. A systematic review of physicians' survival predictions in terminally ill cancer patients. BMJ. 2003 Jul 26;327(7408):195-8. Review.

ReferenceCitation: Asola R, Huhtala H, Holli K. Intensity of diagnostic and treatment activities during the end of life of patients with advanced breast cancer. Breast Cancer Res Treat. 2006 Nov;100(1):77-82. Epub 2006 Jun 7.

ReferenceCitation: Braga S, Miranda A, Fonseca R, Passos-Coelho JL, Fernandes A, Costa JD, Moreira A. The aggressiveness of cancer care in the last three months of life: a retrospective single centre analysis. Psychooncology. 2007 Sep;16(9):863-8.

ReferenceCitation: A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8. Erratum in: JAMA 1996 Apr 24;275(16):1232.

ReferenceCitation: Chvetzoff G, Perol D, Devaux Y, Lancry L, Rebattu P, Magnet M, Dubost E, Bertrand M, Garcon C, Thevenet G, Gobet S, Arbiol E, Saltel P. [Prospective study on the quality of care and quality of life in advanced cancer patients treated at home or in hospital: intermediate analysis of the Trapado study]. Bull Cancer. 2006 Feb;93(2):213-21. French.

ReferenceCitation: Homsi J, Walsh D, Nelson KA, LeGrand SB, Davis M, Khawam E, Nouneh C. The impact of a palliative medicine consultation service in medical oncology. Support Care Cancer. 2002 May;10(4):337-42. Epub 2002 Feb 15.

ReferenceCitation: Manfredi PL, Morrison RS, Morris J, Goldhirsch SL, Carter JM, Meier DE. Palliative care consultations: how do they impact the care of hospitalized patients? J Pain Symptom Manage. 2000 Sep;20(3):166-73.

ReferenceCitation: McLachlan SA, Allenby A, Matthews J, Wirth A, Kissane D, Bishop M, Beresford J, Zalcberg J. Randomized trial of coordinated psychosocial interventions based on patient self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. J Clin Oncol. 2001 Nov 1;19(21):4117-25.

ReferenceCitation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.

ReferenceCitation: Cousson-Gélie F, Irachabal S, Bruchon-Schweitzer M, Dilhuydy JM, Lakdja F. Dimensions of cancer locus of control scale as predictors of psychological adjustment and survival in breast cancer patients. Psychol Rep. 2005 Dec;97(3):699-711.

ReferenceCitation: Bolognini M, Bettschart W, Zehnder-Gubler M, Rossier L. The validity of the French version of the GHQ-28 and PSYDIS in a community sample of 20 year olds in Switzerland. Eur Arch Psychiatry Neurol Sci. 1989;238(3):161-8.

ReferenceCitation: Barlési F, Chabert-Greillier L, Loundou A, Siméoni MC, Greillier L, Doddoli C, Astoul P, Auquier P. [Validation of the French version of the Princess Margaret Hospital Patient Satisfaction with their Doctor Questionnaire]. Rev Mal Respir. 2006 Jun;23(3 Pt 1):227-36. French.

ReferenceCitation: O'Mahony S, Blank AE, Zallman L, Selwyn PA. The benefits of a hospital-based inpatient palliative care consultation service: preliminary outcome data. J Palliat Med. 2005 Oct;8(5):1033-9.

ReferenceCitation: Virik K, Glare P. Profile and evaluation of a palliative medicine consultation service within a tertiary teaching hospital in Sydney, Australia. J Pain Symptom Manage. 2002 Jan;23(1):17-25.

ReferenceCitation: Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980 Jun;36(2):343-6.

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

ReferenceCitation: Kleinbaum DG, Klein M. In: Springer N-Y. Logistic regression. A Self-Learning Text. 2002

ReferenceCitation: In: EORTC Quality of Life Study Group. Brussels. EORTC QLQC-30 scoring manual, 2nd ed. 1999

ReferenceCitation: Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J; Quality of Life Committee of the NCIC CTG. Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer. 2005 Jan;41(2):280-7.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
Institut Curie

intervention_type: Other


title: Trends in Risk of Mother-to-child Transmission of Hepatitis C Through Analysis of Prevalence of Risk Factors for Maternal Infection Among a Southern European Population

acronym: EPIALHICE B

summary:
According to the centres taking part in the ALHICE survey, the number of HIV-HCV co-infected women is currently decreasing. This drop was first noted in 2006 and persisted in 2007. What might have been considered a chance phenomenon during the first year (2006) was confirmed in the beginning of 2008. In view of this information, the investigators wished to ascertain the reality of this trend and to investigate its causes, by attempting to answer the following questions: - Has the prevalence of risk factors for HCV infection changed among the general population over the past 10 years?

Has the prevalence of risk factors for HCV infection changed among HIV/HCV co-infected women over the past 10 years?
Is the change in the number of co-infected women who gave birth during the past 10 years related to the prevalence of certain risk factors among this population?
Is the change in the number of co-infected women who gave birth during the past 10 years related to a decrease in certain risk factors for HCV infection among the general population?
Have changes in addictive behaviour among women of child-bearing age played a role in the decreasing number of HCV-contaminated children? Furthermore, follow-up data from HCV-infected children born during this period will provide information concerning the course of HCV infection.

The objectives are to study trends in numbers of deliveries among HCV/HIV co-infected women as well as trends in risk factors for HCV infection among women of child bearing age and lastly to create a cohort of HCV infected children.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU Toulouse
CHU Montpellier
CHU Nice


title: Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)

acronym: Drone-Curare

summary: Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.

primary_purpose: Treatment

lead_sponsor: Hopital Foch

location_facility:
Institut Paoli-Calmette
CHU Besançon
Hôpital Foch


summary:
It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis.

Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator.

Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.

ReferenceType: derived

ReferenceCitation: Millot F, Guilhot J, Baruchel A, Petit A, Bertrand Y, Mazingue F, Lutz P, Vérité C, Berthou C, Galambrun C, Sirvent N, Yakouben K, Schmitt C, Gandemer V, Reguerre Y, Couillault G, Mechinaud F, Cayuela JM. Impact of early molecular response in children with chronic myeloid leukemia treated in the French Glivec phase 4 study. Blood. 2014 Oct 9;124(15):2408-10. doi: 10.1182/blood-2014-05-578567. Epub 2014 Aug 28.

name: Centre d’Investigation Clinique 1402 INSERM, Centre Hospitalier Universitaire de Poitiers, Poitiers, France;

family: Millot

full_name: Frédéric Millot

given: Frédéric

sequence: first

family: Guilhot

full_name: Joelle Guilhot

given: Joelle

sequence: additional

name: Pediatric Department, Assistance Publique–Hôpitaux de Paris and University Paris Diderot, Assistance Publique-Hôpital Saint Louis and Robert Debré, Paris, France;

family: Baruchel

full_name: André Baruchel

given: André

name: Hematology Unit, Hôpital Trousseau, Paris, France;

family: Petit

full_name: Arnaud Petit

given: Arnaud

name: Hematology Unit, Institut d’Hématologie et d’Oncologie Pédiatrique, Hospices Civils de Lyon, Lyon, France;

family: Bertrand

full_name: Yves Bertrand

given: Yves

name: Pediatric Oncology Unit, University Hospital, Lille, France;

family: Mazingue

full_name: Françoise Mazingue

given: Françoise

name: Pediatric Oncology Unit, University Hospital, Strasbourg, France;

family: Lutz

full_name: Patrick Lutz

given: Patrick

name: Pediatric Oncology Unit, University Hospital, Bordeaux, France;

family: Vérité

full_name: Cecile Vérité

given: Cecile

name: Hematology Department, University Hospital, Brest, France;

family: Berthou

full_name: Christian Berthou

given: Christian

name: Hematology Unit, University Hospital, Marseille, France;

family: Galambrun

full_name: Claire Galambrun

given: Claire

name: Pediatric Oncology Unit, University Hospital, Montpellier, France;

family: Sirvent

full_name: Nicolas Sirvent

given: Nicolas

name: Hematology Unit, Hôpital Robert Debré, Paris, France;

family: Yakouben

full_name: Karima Yakouben

given: Karima

name: Hematology Unit, University Hospital, Nancy, France;

family: Schmitt

full_name: Claudine Schmitt

given: Claudine

name: Pediatric Oncology Unit, University Hospital, Rennes, France;

family: Gandemer

full_name: Virginie Gandemer

given: Virginie

name: Pediatric Oncology Unit, University Hospital, Angers, France;

family: Reguerre

full_name: Yves Reguerre

name: Pediatric Oncology Unit, University Hospital, Dijon, France;

family: Couillault

full_name: Gérard Couillault

given: Gérard

name: Pediatric Oncology Unit, University Hospital, Nantes, France; and

family: Mechinaud

full_name: Françoise Mechinaud

name: Laboratory of Molecular Hematology, University Hospital Saint-Louis, Assistance Publique–Hôpitaux de Paris and EA3518 Unit, University Paris Diderot, Paris, France

family: Cayuela

full_name: Jean-Michel Cayuela

given: Jean-Michel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Blood

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Millot F, Baruchel A, Guilhot J, Petit A, Leblanc T, Bertrand Y, Mazingue F, Lutz P, Vérité C, Berthou C, Galambrun C, Bernard F, Yacouben K, Bordigoni P, Edan C, Reguerre Y, Couillault G, Méchinaud F, Cayuela JM, Guilhot F. Imatinib is effective in children with previously untreated chronic myelogenous leukemia in early chronic phase: results of the French national phase IV trial. J Clin Oncol. 2011 Jul 10;29(20):2827-32. doi: 10.1200/JCO.2010.32.7114. Epub 2011 Jun 13.

name: Frédéric Millot, Joelle Guilhot, and François Guilhot, Centre d'Investigation Clinique 802, Institut National de la Santé et de la Recherche Médicale (INSERM), University Hospital Poitiers, Poitiers; André Baruchel and Thierry Leblanc, Assistance Publique–Hôpitaux de Paris and University Paris Diderot, Assistance Publique–Hôpital Saint Louis and Robert Debré; Arnaud Petit, Hôpital Trousseau; Karima Yacouben, Hôpital Robert Debré; Jean-Michel Cayuela, INSERM U944, Hôpital Saint Louis, Paris; Yves Bertrand...

publisher: American Society of Clinical Oncology (ASCO)

title: Imatinib Is Effective in Children With Previously Untreated Chronic Myelogenous Leukemia in Early Chronic Phase: Results of the French National Phase IV Trial

location_facility:
Hôpital La Timone - CHU de Marseille
Hôpital de Brabois - CHU de Nancy
CHU Amiens


title: A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients With Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Patisiran Clinical Study

summary: The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

status: Active, not recruiting

ReferenceCitation: Adams D, Polydefkis M, González-Duarte A, Wixner J, Kristen AV, Schmidt HH, Berk JL, Losada López IA, Dispenzieri A, Quan D, Conceição IM, Slama MS, Gillmore JD, Kyriakides T, Ajroud-Driss S, Waddington-Cruz M, Mezei MM, Planté-Bordeneuve V, Attarian S, Mauricio E, Brannagan TH 3rd, Ueda M, Aldinc E, Wang JJ, White MT, Vest J, Berber E, Sweetser MT, Coelho T; patisiran Global OLE study group. Long-term safety and efficacy of patisiran for hereditary transthyretin-mediated amyloidosis with polyneuropathy: 12-month results of an open-label extension study. Lancet Neurol. 2021 Jan;20(1):49-59. doi: 10.1016/S1474-4422(20)30368-9. Epub 2020 Nov 16. Erratum in: Lancet Neurol. 2021 Feb;20(2):e2.

family: Adams

full_name: David Adams

given: David

family: Polydefkis

full_name: Michael Polydefkis

given: Michael

family: González-Duarte

full_name: Alejandra González-Duarte

given: Alejandra

family: Wixner

full_name: Jonas Wixner

given: Jonas

family: Kristen

full_name: Arnt V Kristen

given: Arnt V

family: Schmidt

full_name: Hartmut H Schmidt

given: Hartmut H

family: Berk

full_name: John L Berk

given: John L

family: Losada López

full_name: Inés Asunción Losada López

given: Inés Asunción

family: Dispenzieri

full_name: Angela Dispenzieri

given: Angela

family: Quan

full_name: Dianna Quan

given: Dianna

family: Conceição

full_name: Isabel M Conceição

given: Isabel M

family: Slama

full_name: Michel S Slama

given: Michel S

family: Gillmore

full_name: Julian D Gillmore

given: Julian D

family: Kyriakides

full_name: Theodoros Kyriakides

given: Theodoros

family: Ajroud-Driss

full_name: Senda Ajroud-Driss

given: Senda

family: Waddington-Cruz

full_name: Márcia Waddington-Cruz

given: Márcia

family: Mezei

full_name: Michelle M Mezei

given: Michelle M

family: Planté-Bordeneuve

full_name: Violaine Planté-Bordeneuve

given: Violaine

family: Attarian

full_name: Shahram Attarian

given: Shahram

family: Mauricio

full_name: Elizabeth Mauricio

given: Elizabeth

family: Brannagan

full_name: Thomas H Brannagan

given: Thomas H

suffix: III

family: Ueda

full_name: Mitsuharu Ueda

given: Mitsuharu

family: Aldinc

full_name: Emre Aldinc

given: Emre

family: Wang

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

repository_institution: University College London - UCL Discovery

location_country:
Malaysia
Australia
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Cyprus
Spain
Turkey


title: European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption

acronym: EVIDENCE

summary: The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.

time_perspective: Prospective

ReferenceCitation: Lanas A, Boers M, Nuevo J. Gastrointestinal events in at-risk patients starting non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatic diseases: the EVIDENCE study of European routine practice. Ann Rheum Dis. 2015 Apr;74(4):675-81. doi: 10.1136/annrheumdis-2013-204155. Epub 2013 Dec 18.

family: Lanas

full_name: Angel Lanas

given: Angel

family: Boers

full_name: Maarten Boers

given: Maarten

family: Nuevo

full_name: Javier Nuevo

given: Javier

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: AstraZeneca

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Greece
Norway
Belgium
Spain
Turkey
Germany
United Kingdom


title: Survey on the Expectations of Adolescents With Juvenile Idiopathic Arthritis (JIA) Regarding Knowledge and Communication With Health Care Professionals in the Field of Sexual Health, and Their Parents' Views on the Subject.

acronym: SNAPS-JIA

summary:
Sexual health is a legitimate area to explore in the care of these patients, as it has such an impact on quality of life. However, addressing sexual health in a situation of chronic disease confronts the double societal taboo of disease and sexuality. Health professionals are uncomfortable because they are not trained to talk about the subject, especially in the presence of parents and with a teenager they have watched grow up.

In this context, a needs survey among juvenile idiopathic arthritis (JIA) patients and the point of view of their parents in the field of sexual health seems necessary.

Main objective: To determine the expectations of adolescents (aged 10-19 years) with juvenile idiopathic arthritis regarding knowledge and communication with health care professionals in the field of sexual health.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: CHU de Strasbourg - Hôpital de Hautepierre

location_facility: Association Nationale de Défense contre l'Arthrite Rhumatoïde

status_simplified: Ongoing


type: EudraCT Number

title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

summary: To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

status: Terminated

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
South Africa
Sweden
Serbia
Finland
France
Poland
Estonia
United States


type: Other Identifier

title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects

acronym: HEART

summary: This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070, daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol concentration (determined by ultracentrifugation method) after 24 weeks of consumption.

study_start_date_type: Actual

ipd_sharing: No

lead_sponsor: Valbiotis

location_country: Germany France

location_facility: Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

intervention_type: Dietary Supplement


title: A Phase 1 Dose Escalation and Expansion Study of CID-103, an Anti-CD38 Antibody, in Patients With Previously Treated Relapsed or Refractory Multiple Myeloma

summary: Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities.

status: Recruiting

design_allocation: Non-Randomized

lead_sponsor: CASI Pharmaceuticals, Inc.

location_country:
United Kingdom
France

location_facility:
Gustave Roussy Cancer Center
Sarah Cannon
CHU de Nantes - Hôpital Hôtel-Dieu
CHU Rennes - Pontchaillou


title: IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel

summary: Open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of weekly paclitaxel (80 mg/m² at D1, D8 and D15 of a 4-week cycle). Three IMP321 doses (0.25, 1.25 and 6.25 mg) will be tested and given at D2 and D16 of this 4-week cycle, for 6 courses.

ReferenceCitation: Brignone C, Gutierrez M, Mefti F, Brain E, Jarcau R, Cvitkovic F, Bousetta N, Medioni J, Gligorov J, Grygar C, Marcu M, Triebel F. First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity. J Transl Med. 2010 Jul 23;8:71. doi: 10.1186/1479-5876-8-71.

family: Brignone

full_name: Chrystelle Brignone

given: Chrystelle

family: Gutierrez

full_name: Maya Gutierrez

given: Maya

family: Mefti

full_name: Fawzia Mefti

given: Fawzia

family: Brain

full_name: Etienne Brain

given: Etienne

family: Jarcau

full_name: Rosana Jarcau

given: Rosana

family: Cvitkovic

full_name: Frédérique Cvitkovic

given: Frédérique

family: Bousetta

full_name: Nabil Bousetta

given: Nabil

family: Medioni

full_name: Jacques Medioni

given: Jacques

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

family: Grygar

full_name: Caroline Grygar

given: Caroline

family: Marcu

full_name: Manon Marcu

given: Manon

family: Triebel

full_name: Frédéric Triebel

given: Frédéric

currency_apc_doaj: GBP

journal_name: Journal of Translational Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Immutep S.A.S.

location_facility:
Hôpital Européen Georges Pompidou
Centre René Huguenin
Hôpital Tenon

intervention_type: Biological


title: Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma

summary:
In this open-label randomised phase I trial, bortezomib will be administrated to 2 groups of 10 patients with MM who have inclusion criteria use the extended 2nd line indication, either intravenously (group 1 = 10 patients) or subcutaneously (group 2 = 10 patients). The schedule of administration of bortezomib will be the following : 1.3 mg per square meter of body-surface area twice weekly for 2 weeks, followed by 1 week without treatment, for up to eight cycles, either IV (group 1) or SC (group 2).

The primary objective is to characterize the pharmacokinetics of the 2 routes of administration.

The secondary objectives are to characterize the pharmacodynamics (20S proteasome inhibition in whole blood), toxicity, including cardiac safety, and efficacy of the 2 routes of administration.

ReferenceCitation: Moreau P, Coiteux V, Hulin C, Leleu X, van de Velde H, Acharya M, Harousseau JL. Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma. Haematologica. 2008 Dec;93(12):1908-11. doi: 10.3324/haematol.13285. Epub 2008 Sep 2.

family: Moreau

full_name: P. Moreau

given: P.

family: Coiteux

full_name: V. Coiteux

given: V.

family: Hulin

full_name: C. Hulin

given: C.

family: Leleu

full_name: X. Leleu

given: X.

family: van de Velde

full_name: H. van de Velde

given: H.

family: Acharya

full_name: M. Acharya

given: M.

family: Harousseau

full_name: J.-L. Harousseau

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Nantes University Hospital

location_facility:
Nancy UH
Nantes UH
Lille UH


title: Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab

summary: Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.

ReferenceCitation: Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. doi: 10.3324/haematol.2009.011759. Epub 2010 Mar 10.

family: Gressin

full_name: R. Gressin

given: R.

family: Caulet-Maugendre

full_name: S. Caulet-Maugendre

given: S.

family: Deconinck

full_name: E. Deconinck

given: E.

family: Tournilhac

full_name: O. Tournilhac

given: O.

family: Gyan

full_name: E. Gyan

family: Moles

full_name: M. P. Moles

given: M. P.

family: Yamani

full_name: A. E. Yamani

given: A. E.

family: Cornillon

full_name: J. Cornillon

given: J.

family: Rossi

full_name: J. F. Rossi

given: J. F.

family: Le Gouill

full_name: S. Le Gouill

family: Lepeu

full_name: G. Lepeu

given: G.

family: Damaj

full_name: G. Damaj

family: Celigny

full_name: P. S. Celigny

given: P. S.

family: Maisonneuve

full_name: H. Maisonneuve

family: Corront

full_name: B. Corront

given: B.

family: Vilque

full_name: J. P. Vilque

given: J. P.

family: Casassus

full_name: P. Casassus

family: Lamy

full_name: T. Lamy

given: T.

family: Colonna

full_name: M. Colonna

family: Colombat

full_name: P. Colombat

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

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_facility:
REgional Hospital
Regional university hospital


title: Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

summary: Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine ePortal for sharing information between diabetologist and type 1 diabetic patient is not inferior to a conventional care regarding metabolic results at 12 months.

ReferenceCitation: Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9.

ReferenceCitation: Farmer AJ, Gibson OJ, Dudley C, Bryden K, Hayton PM, Tarassenko L, Neil A. A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Diabetes Care. 2005 Nov;28(11):2697-702.

ReferenceCitation: Montori VM, Helgemoe PK, Guyatt GH, Dean DS, Leung TW, Smith SA, Kudva YC. Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Diabetes Care. 2004 May;27(5):1088-94.

ReferenceCitation: Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. Epub 2007 Mar 28.

ReferenceCitation: Boizel R, Benhamou PY, Renard E; Accu-Chek Pocket Compass Study Group. Glucose monitoring and pump data management software operated on a personal digital assistant can contribute to improve diabetes control in CSII-treated patients. Diabetes Metab. 2007 Sep;33(4):314-5. Epub 2007 May 1.

ReferenceCitation: Young RJ, Taylor J, Friede T, Hollis S, Mason JM, Lee P, Burns E, Long AF, Gambling T, New JP, Gibson JM. Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2005 Feb;28(2):278-82.

ReferenceCitation: Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159.

ReferenceCitation: Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31.

ReferenceCitation: Tate DF, Jackvony EH, Wing RR. Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003 Apr 9;289(14):1833-6.

ReferenceCitation: Trief PM, Sandberg J, Izquierdo R, Morin PC, Shea S, Brittain R, Feldhousen EB, Weinstock RS. Diabetes management assisted by telemedicine: patient perspectives. Telemed J E Health. 2008 Sep;14(7):647-55. doi: 10.1089/tmj.2007.0107.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital of Lyon (HCL Lyon sud)

location_facility: University Hospital of Caen (Hospital Côte de nacre)

location_facility: University Hospital of Besancon - Hospital Jean Minjoz


title: Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

acronym: T-DEF

summary: This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.

lead_sponsor: CMC Ambroise Paré

location_facility: Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois

intervention_type: Diagnostic Test


title: Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study

acronym: EASY TAVI

summary: The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method.

primary_purpose: Other

ReferenceCitation: Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

family: Adams

full_name: David H. Adams

given: David H.

family: Popma

full_name: Jeffrey J. Popma

given: Jeffrey J.

family: Reardon

full_name: Michael J. Reardon

given: Michael J.

family: Yakubov

full_name: Steven J. Yakubov

given: Steven J.

family: Coselli

full_name: Joseph S. Coselli

given: Joseph S.

family: Deeb

full_name: G. Michael Deeb

given: G. Michael

family: Gleason

full_name: Thomas G. Gleason

given: Thomas G.

family: Buchbinder

full_name: Maurice Buchbinder

given: Maurice

family: Hermiller

full_name: James Hermiller

given: James

suffix: Jr.

family: Kleiman

full_name: Neal S. Kleiman

given: Neal S.

family: Chetcuti

full_name: Stan Chetcuti

given: Stan

family: Heiser

full_name: John Heiser

given: John

family: Merhi

full_name: William Merhi

given: William

family: Zorn

full_name: George Zorn

given: George

family: Tadros

full_name: Peter Tadros

given: Peter

family: Robinson

full_name: Newell Robinson

given: Newell

family: Petrossian

full_name: George Petrossian

family: Hughes

full_name: G. Chad Hughes

given: G. Chad

family: Harrison

full_name: J. Kevin Harrison

given: J. Kevin

family: Conte

full_name: John Conte

family: Maini

full_name: Brijeshwar Maini

given: Brijeshwar

family: Mumtaz

full_name: Mubashir Mumtaz

given: Mubashir

family: Chenoweth

full_name: Sharla Chenoweth

title: Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis

ReferenceCitation: Arnold SV, Reynolds MR, Wang K, Magnuson EA, Baron SJ, Chinnakondepalli KM, Reardon MJ, Tadros PN, Zorn GL, Maini B, Mumtaz MA, Brown JM, Kipperman RM, Adams DH, Popma JJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1207-1217. doi: 10.1016/j.jcin.2015.04.018.

ReferenceCitation: Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8.

ReferenceCitation: Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004 Feb 18;43(4):698-703.

ReferenceCitation: Eggebrecht H, Mehta RH, Kahlert P, Schymik G, Lefèvre T, Lange R, Macaya C, Mandinov L, Wendler O, Thomas M. Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): insights from the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry. EuroIntervention. 2014 Dec;10(8):975-81. doi: 10.4244/EIJV10I8A165.

ReferenceCitation: Faurie B, Abdellaoui M, Wautot F, Staat P, Champagnac D, Wintzer-Wehekind J, Vanzetto G, Bertrand B, Monségu J. Rapid pacing using the left ventricular guidewire: Reviving an old technique to simplify BAV and TAVI procedures. Catheter Cardiovasc Interv. 2016 Nov 15;88(6):988-993. doi: 10.1002/ccd.26666. Epub 2016 Aug 11.

ReferenceCitation: Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.

ReferenceCitation: Karagöz T, Aypar E, Erdoğan I, Sahin M, Ozer S, Celiker A. Congenital aortic stenosis: a novel technique for ventricular pacing during valvuloplasty. Catheter Cardiovasc Interv. 2008 Oct 1;72(4):527-30. doi: 10.1002/ccd.21695.

ReferenceCitation: Lefèvre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schächinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.

name: on behalf of the PARTNER EU Investigator Group

repositories_institution:
Erasmus University, Rotterdam - RePub
PubMed Central - Europe PMC

ReferenceCitation: Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

title: Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

ReferenceCitation: Navarini S, Pfammatter JP, Meier B. Left ventricular guidewire pacing to simplify aortic balloon valvuloplasty. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):426-7. doi: 10.1002/ccd.21810.

ReferenceCitation: Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

journal_name: Journal of the American College of Cardiology

title: Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery

ReferenceCitation: Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

title: Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

ReferenceCitation: Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, Wendler O. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011 Jul 26;124(4):425-33. doi: 10.1161/CIRCULATIONAHA.110.001545. Epub 2011 Jul 11.

ReferenceCitation: Walther T, Hamm CW, Schuler G, Berkowitsch A, Kötting J, Mangner N, Mudra H, Beckmann A, Cremer J, Welz A, Lange R, Kuck KH, Mohr FW, Möllmann H; GARY Executive Board. Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry. J Am Coll Cardiol. 2015 May 26;65(20):2173-80. doi: 10.1016/j.jacc.2015.03.034. Epub 2015 Mar 15.

ReferenceCitation: Wenaweser P, Pilgrim T, Roth N, Kadner A, Stortecky S, Kalesan B, Meuli F, Büllesfeld L, Khattab AA, Huber C, Eberle B, Erdös G, Meier B, Jüni P, Carrel T, Windecker S. Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes. Am Heart J. 2011 Jun;161(6):1114-24. doi: 10.1016/j.ahj.2011.01.025. Epub 2011 May 11.

ReferenceCitation: Vogel R, Meier B. Emergent mechanical and electrical guidewire pacing of the right ventricle for aystole in the cardiac catheterization laboratory. J Invasive Cardiol. 2005 Sep;17(9):490.

ReferenceCitation: Faurie B, Souteyrand G, Staat P, Godin M, Caussin C, Van Belle E, Mangin L, Meyer P, Dumonteil N, Abdellaoui M, Monségu J, Durand-Zaleski I, Lefèvre T; EASY TAVI Investigators. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2449-2459. doi: 10.1016/j.jcin.2019.09.029. Epub 2019 Sep 28.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Groupement Hospitalier Mutualiste de Grenoble


title: Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach

acronym: TRANSREG

summary: TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

ReferenceCitation: Rosenzwajg M, Lorenzon R, Cacoub P, Pham HP, Pitoiset F, El Soufi K, RIbet C, Bernard C, Aractingi S, Banneville B, Beaugerie L, Berenbaum F, Champey J, Chazouilleres O, Corpechot C, Fautrel B, Mekinian A, Regnier E, Saadoun D, Salem JE, Sellam J, Seksik P, Daguenel-Nguyen A, Doppler V, Mariau J, Vicaut E, Klatzmann D. Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial. Ann Rheum Dis. 2019 Feb;78(2):209-217. doi: 10.1136/annrheumdis-2018-214229. Epub 2018 Nov 24.

family: Rosenzwajg

full_name: Michelle Rosenzwajg

given: Michelle

family: Lorenzon

full_name: Roberta Lorenzon

given: Roberta

family: Cacoub

full_name: Patrice Cacoub

given: Patrice

family: Pham

full_name: Hang Phuong Pham

given: Hang Phuong

family: Pitoiset

full_name: Fabien Pitoiset

given: Fabien

family: El Soufi

full_name: Karim El Soufi

given: Karim

family: RIbet

full_name: Claire RIbet

given: Claire

family: Bernard

full_name: Claude Bernard

given: Claude

family: Aractingi

full_name: Selim Aractingi

given: Selim

family: Banneville

full_name: Beatrice Banneville

given: Beatrice

family: Beaugerie

full_name: Laurent Beaugerie

given: Laurent

family: Berenbaum

full_name: Francis Berenbaum

given: Francis

family: Champey

full_name: Julien Champey

given: Julien

family: Chazouilleres

full_name: Olivier Chazouilleres

given: Olivier

family: Corpechot

full_name: Christophe Corpechot

given: Christophe

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Mekinian

full_name: Arsène Mekinian

given: Arsène

family: Regnier

full_name: Elodie Regnier

given: Elodie

family: Saadoun

full_name: David Saadoun

given: David

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Sellam

full_name: Jérémie Sellam

given: Jérémie

family: Seksik

full_name: Philippe Seksik

given: Philippe

family: Daguenel-Nguyen

full_name: Anne Daguenel-Nguyen

given: Anne

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

location_facility: Service de Médecine Interne - Hôpital PITIE SALPETRIERE

location_facility: Service de Dermatologie - Hôpital COCHIN

location_facility: Service de Rhumatologie - Hôpital SAINT-ANTOINE

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse

location_facility: Service de Gastro Entérologie - Hôpital SAINT-ANTOINE

location_facility: Service d' Hépato Gastro Entérologie - Hôpital SAINT-ANTOINE

location_facility: Médecine interne - Hôpital Saint-Antoine

location_facility: Service de Rhumatologie - Hôpital PITIE SALPETRIERE


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy

summary: To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.

ReferenceCitation: Dougados M, Combe B, Braun J, Landewé R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28.

family: Dougados

full_name: M. Dougados

given: M.

family: Combe

full_name: B. Combe

given: B.

family: Braun

full_name: J. Braun

given: J.

family: Landewe

full_name: R. Landewe

given: R.

family: Sibilia

full_name: J. Sibilia

family: Cantagrel

full_name: A. Cantagrel

given: A.

family: Feydy

full_name: A. Feydy

family: van der Heijde

full_name: D. van der Heijde

given: D.

family: Leblanc

full_name: V. Leblanc

given: V.

family: Logeart

full_name: I. Logeart

given: I.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Germany France Netherlands


title: Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.

acronym: BAXASSO

summary:
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.

The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.

location_facility:
Clinique La Montagne
Hôpital Privé Armand Brillard
CMC Ambroise Paré
Clinique Médipôle Garonne
Clinique Rémusat
Hôpital Privé Paul D'Egine
Clinique Lille Sud
Clinique Bizet
Clinique Jouvenet

intervention_type: Procedure


title: Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction

summary:
The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:

Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase

ReferenceCitation: Di Mario C, Bolognese L, Maillard L, Dudek D, Gambarati G, Manari A, Guiducci V, Patrizi G, Rusconi LC, Piovaccari G, Hibon AR, Belpomme V, Indolfi C, Olivari Z, Steffenino G, Zmudka K, Airoldi F, Panzarasa R, Flather M, Steg PG. Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI). Am Heart J. 2004 Sep;148(3):378-85.

ReferenceCitation: Di Mario C, Dudek D, Piscione F, Mielecki W, Savonitto S, Murena E, Dimopoulos K, Manari A, Gaspardone A, Ochala A, Zmudka K, Bolognese L, Steg PG, Flather M; CARESS-in-AMI (Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction) Investigators. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet. 2008 Feb 16;371(9612):559-68. doi: 10.1016/S0140-6736(08)60268-8.

family: Di Mario

full_name: Carlo Di Mario

given: Carlo

family: Dudek

full_name: Dariusz Dudek

given: Dariusz

family: Piscione

full_name: Federico Piscione

given: Federico

family: Mielecki

full_name: Waldemar Mielecki

given: Waldemar

family: Savonitto

full_name: Stefano Savonitto

given: Stefano

family: Murena

full_name: Ernesto Murena

given: Ernesto

family: Dimopoulos

full_name: Konstantinos Dimopoulos

given: Konstantinos

family: Manari

full_name: Antonio Manari

given: Antonio

family: Gaspardone

full_name: Achille Gaspardone

given: Achille

family: Ochala

full_name: Andrzej Ochala

given: Andrzej

family: Zmudka

full_name: Krzysztof Zmudka

given: Krzysztof

family: Bolognese

full_name: Leonardo Bolognese

given: Leonardo

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Flather

full_name: Marcus Flather

given: Marcus

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Società Italiana di Cardiologia Invasiva

location_country: Italy France Poland

location_facility: II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie

location_facility: Oddzial Kardiologii - Szpital Miejski w Tychach

location_facility: Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej

location_facility: Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika

location_facility: Fondazione Centro San Raffaele del Monte Tabor IRCCS

location_facility: Oddzial Kardiologii - Szpital Powiatowy w Zakopane

location_facility: Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej

location_facility: Zaklad Hemodynamiki i Angiokardiografii Pracownia 1

location_facility: Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu

location_facility: Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2

location_facility: Nuovo Ospedale S. Agostino Estense - Baggiovara

location_facility: Oddzial Wewneztrnj Okregowy Szpital Kolciowy

location_facility: Szpital Powiatowy im. Jana Pawla II w Wadowicach

location_facility: Oddzial Wewnetrzny - Szpital Mijski w Krynicy

location_facility: First Dept. Cardiology - Gornoslaskiego Centrum Medycznego

location_facility: Service de Cardiologie - Hopital St. Joseph


title: A Two-arm, Phase 2/3 Multicentre, Open-label, Randomised Study Evaluating Safety and Antiviral Effect of Current Standard Antiretroviral Therapy Compared to Once Daily Integrase Inhibitor Administered With Darunavir/Ritonavir (DRV/r) in HIV-1 Infected, Virologically Suppressed Paediatric Participants.

acronym: SMILE

summary: A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.

lead_sponsor: PENTA Foundation

location_country:
South Africa
Switzerland
Mexico
Spain
France
Thailand
Uganda
Argentina
Portugal
United Kingdom
Ukraine

location_facility: Evelina Children Hospital, St Thomas's Hospital


title: Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2)

acronym: NiloPost-STIM

summary:
Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing durable responses. However, requiring continuing IM indefinitely and the ability of IM to eradicate the CML clone was uncertain.

In a small proportion of patients, IM can induce complete molecular response (CMR) defined by the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question whether or not these patients are cured and can discontinue drug therapy has been assessed by Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in patient with a CMR of at least 2 year duration and all patients who relapsed after IM discontinuation mainly did it in the first 6 months and responded to reintroduction of imatinib.

Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved target specificity over imatinib. Its efficacy and safety in the treatment of patients who are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led to the registration in second and first line treatment of CML-CP patients. Nilotinib produces even faster and deeper responses with more occurrence of CMR than does Imatinib. Consequently, one can assume that a more potent drug such nilotinib could induce deeper and sustained CMR allowing longer period off treatment than IM.

The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Nice, Service Hématologie Clinique

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot - Service de Médecine B

location_facility: Centre Hospitalier Lyon Sud, Service Hématologie

location_facility: Hôpital Haut Lévêque, Service Hématologie


title: Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay

acronym: CONVERSTIM

summary:
Conversion disorder refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments and symptoms persist in 35% of patients after 12 years of evolution. Despite a poor prognosis, no treatments have been validated to date.

The development of non-invasive brain stimulation techniques has allowed the creation of treatments focused on dysfunctional brain regions associated with motor conversion disorder. Hypoactivation of prefrontal dorso-lateral cortex underlies the course of functional motor symptoms. Results of the HYCORE study conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms.

However, in most repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted and the clinical improvement was related to self-suggestion induced by the motor response produced.

Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Hospices Civils de Lyon Hôpital Edouard Herriot

location_facility: CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie

location_facility: Hôpital La Colombière Service de Psychiatrie

location_facility: Hôpital Saint-Antoine Service de Psychiatrie APHP


title: TPExtreme: Randomized, Controlled Trial of Platinum-Cetuximab Combined Either With Docetaxel (TPEx) or With 5FU (Extreme) in Patients With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck

acronym: TPExtreme

summary: This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.

ReferenceCitation: Guigay J, Aupérin A, Fayette J, Saada-Bouzid E, Lafond C, Taberna M, Geoffrois L, Martin L, Capitain O, Cupissol D, Castanie H, Vansteene D, Schafhausen P, Johnson A, Even C, Sire C, Duplomb S, Evrard C, Delord JP, Laguerre B, Zanetta S, Chevassus-Clément C, Fraslin A, Louat F, Sinigaglia L, Keilholz U, Bourhis J, Mesia R; GORTEC; AIO; TTCC, and UniCancer Head and Neck groups. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2021 Apr;22(4):463-475. doi: 10.1016/S1470-2045(20)30755-5. Epub 2021 Mar 5.

family: Guigay

full_name: Joël Guigay

given: Joël

family: Aupérin

full_name: Anne Aupérin

given: Anne

family: Fayette

full_name: Jérôme Fayette

given: Jérôme

family: Saada-Bouzid

full_name: Esma Saada-Bouzid

given: Esma

family: Lafond

full_name: Cédrik Lafond

given: Cédrik

family: Taberna

full_name: Miren Taberna

given: Miren

family: Geoffrois

full_name: Lionnel Geoffrois

given: Lionnel

family: Martin

full_name: Laurent Martin

given: Laurent

family: Capitain

full_name: Olivier Capitain

given: Olivier

family: Cupissol

full_name: Didier Cupissol

given: Didier

family: Castanie

full_name: Hélène Castanie

given: Hélène

family: Vansteene

full_name: Damien Vansteene

given: Damien

family: Schafhausen

full_name: Philippe Schafhausen

given: Philippe

family: Johnson

full_name: Alison Johnson

given: Alison

family: Even

full_name: Caroline Even

given: Caroline

family: Sire

full_name: Christian Sire

given: Christian

family: Duplomb

full_name: Sophie Duplomb

given: Sophie

family: Evrard

full_name: Camille Evrard

given: Camille

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Laguerre

full_name: Brigitte Laguerre

given: Brigitte

family: Zanetta

full_name: Sylvie Zanetta

given: Sylvie

family: Chevassus-Clément

full_name: Cécile Chevassus-Clément

given: Cécile

family: Fraslin

full_name: Aldéric Fraslin

given: Aldéric

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility: Centre Hospitalier de Bretagne Sud (CHBS)

location_facility: Institut de Cancérologie de l'Ouest (ICO) René Gauducheau

location_facility: L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin


type: Other Grant/Funding Number

title: National Real-life Study of Tumor Mutational Burden Assessment in First-line Lung Cancer

acronym: MUBULUC

summary: Tumor mutational burden (TMB) seems to be is an important marker for immune checkpoint inhibitors efficacy. This study aims to assess the feasibility of the TMB assessment in first-line lung cancer in routine practice both on biopsy and surgical tumor samples. Results will be an element of discussion for the generalization of the TMB implementation in cancer centers.

ipd_sharing: Yes

ipd_sharing_description:
Individual participant data (IPD) that underlie results in publication could be shared.

IPD detailed in the protocol of a planned metaanalysis could be shared.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP - Hôpital Européen Georges-Pompidou


type: Registry Identifier

title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study

acronym: PERFUSE

summary: A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) [adults and children] and Ulcerative Colitis (UC) [adults for both treatments and children only for Flixabi].

lead_sponsor: Biogen

location_facility:
Research Site 3
Research Site 4
Research Site
Research Site 1
Research Site 5
Research Site 9
Research Site 6
Research Site 8
Research Site 7
Research Site 2


title: A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures

acronym: TSF

summary: A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.

lead_sponsor: Kuros Biosurgery AG

location_country:
Italy
Serbia
Switzerland
Finland
France
Bulgaria
Slovakia
Slovenia
Romania
Hungary
Germany
Czech Republic

location_facility: Spitalul Universitar de Urgenta Bucuresti (87)

location_facility: MHAT ''Sveti Georgi'', Orthopaedic and Traumatology clinic (85)

location_facility: MHATEM ''N.I.Pirogov'' Second clinic of Orthopaedic and Traumatology (84)

location_facility: Fovarosi Onkormanyzat Szent janos Korhaza (81)


title: Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe

acronym: ABCAL

summary:
Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified.

The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics.

The secondary objectives are:

Rates of infectious complications according to duration of preoperative antibiotic
Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections)
Comparison of germs found in the bile during the postoperative infectious complications
Duration of hospitalization
Readmission rate for surgical site infections
Rate of reoperation for surgical site infection
Overall mortality rate at 30 days
Mortality rates specific to 30 days

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ReferenceCitation: Fuks D, Duhaut P, Mauvais F, Pocard M, Haccart V, Paquet JC, Millat B, Msika S, Sielezneff I, Scotté M, Chatelain D, Regimbeau JM. A retrospective comparison of older and younger adults undergoing early laparoscopic cholecystectomy for mild to moderate calculous cholecystitis. J Am Geriatr Soc. 2015 May;63(5):1010-6. doi: 10.1111/jgs.13330. Epub 2015 May 6.

name: Department of Digestive Surgery; Amiens University Hospital; Amiens France

name: Department of Internal Medicine; Amiens University Hospital; Amiens France

name: Inserm U1088; Faculté de Médecine; Université de Picardie Jules Verne; Amiens France

name: Réseau d'Epidémiologie Clinique International Francophone; Amiens University Hospital; Amiens France

family: Fuks

full_name: David Fuks

given: David

family: Duhaut

full_name: Pierre Duhaut

given: Pierre

name: Department of Digestive Surgery; Beauvais Hospital; Beauvais France

family: Mauvais

full_name: Francois Mauvais

given: Francois

name: Department of Digestive Surgery; Lariboisière University Hospital; Paris France

family: Pocard

full_name: Marc Pocard

given: Marc

name: Department of Digestive Surgery; Montreuil-sur-Mer Hospital; Rang-du-Fliers France

family: Haccart

full_name: Vincent Haccart

given: Vincent

name: Department of Digestive Surgery; Longjumeau Hospital; Longjumeau France

family: Paquet

full_name: Jean-Christophe Paquet

given: Jean-Christophe

name: Department of Digestive Surgery; Montpellier University Hospital; Montpellier France

name: Department of Digestive Surgery; Louis Mourier Hospital; Colombes France

name: Department of Digestive Surgery; La Timone University Hospital; Marseille France

name: Department of Digestive Surgery; Rouen University Hospital; Rouen Cedex France

name: Department of Pathology; Amiens University Hospital; Amiens France

journal_name: Journal of the American Geriatrics Society

title: A Retrospective Comparison of Older and Younger Adults Undergoing Early Laparoscopic Cholecystectomy for Mild to Moderate Calculous Cholecystitis

ReferenceCitation: Regimbeau JM, Fuks D, Pautrat K, Mauvais F, Haccart V, Msika S, Mathonnet M, Scotté M, Paquet JC, Vons C, Sielezneff I, Millat B, Chiche L, Dupont H, Duhaut P, Cossé C, Diouf M, Pocard M; FRENCH Study Group. Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial. JAMA. 2014 Jul;312(2):145-54. doi: 10.1001/jama.2014.7586.

name: Division of Digestive Surgery, Amiens University Medical Center, Amiens, France2Jules Verne University of Picardie, Unit EA4294, Amiens, France3Clinical Research Center, Amiens University Medical Center, Amiens, France

name: Division of Digestive Surgery, Amiens University Medical Center, Amiens, France

name: Division of Digestive Disease, Paris Lariboisière Hospital, Paris, France

name: Division of Digestive Surgery, Beauvais Hospital, Beauvais, France

name: Division of Digestive Surgery, Montreuil-sur-Mer Hospital, Montreuil-sur-Mer, France

name: Division of Digestive Surgery, Louis Mourier University Hospital, Colombes, France

name: Division of Digestive Surgery, Limoges University Hospital, Limoges

name: Division of Digestive Surgery, Rouen University Hospital, Rouen, France

name: Division of Digestive Surgery, Longjumeau Hospital, Longjumeau, France

name: Division of Digestive Surgery, Jean Verdier University Hospital, Bondy, France

name: Division of Digestive Surgery, Marseille University Hospital La Timone, Marseille, France

name: Division of Digestive Surgery, Montpellier University Hospital, Montpellier, France

name: Division of Digestive Surgery, Caen University Hospital, Caen, France

name: Division of Anesthesia and Intensive Care, Amiens University Medical Center, Amiens, France

name: Division of Internal Medicine and Systemic Diseases, Amiens University Medical Center, Amiens, France

name: Division of Clinical Research and Innovation, Amiens University Medical Center, Amiens, France

title: Effect of Postoperative Antibiotic Administration on Postoperative Infection Following Cholecystectomy for Acute Calculous Cholecystitis

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier de Saint-Germain en Laye

location_facility: Service de Chirurgie Viscérale et Digestive

location_facility: Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire

location_facility: Chirurgie viscérale et urologique Centre Hospitalier

location_facility: Service de Chirurgie Digestive et Viscérale

location_facility: Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire

location_facility: Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire

location_facility: Service de Chirurgie Digetsive Centre Hopsitalier Universitaire


title: PROgression of FIbromuscular LEsions

acronym: PROFILE

summary: PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.

location_country: Belgium France

location_facility: CHU de Clermont-Ferrand hopital Gabriel-Montpied

location_facility: CHU de Grenoble hopital Albert-Michallon

location_facility: Centre Hospitalier de Versailles hopital Andre Mignot


title: Assessment of Renal and Cervical Artery DysplasIA

acronym: ARCADIA

summary:
ARCADIA is a national registry designed to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia (FMD).

FMD is a group of arterial diseases that most commonly involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. Angiographic classification includes the multifocal type and the focal type. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD may be familial (OMIM #135580).

Our main objective is to create a FMD registry that will collect standardized information from all consenting patients diagnosed with the condition in 16 participating centers. This registry, along with a collection of leukocyte DNA, will constitute a resource for further clinical research on FMD. The first application will be the assessment of the frequency of multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal artery FMD and vice-versa. The second application will be a case-control study to identify susceptibility genes for FMD.

Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection of bioclinical and morphologic information. Phenotypic assessment will be performed in accordance with current recommendations and best clinical practice.

Given the multicenter nature of the study and the recruitment capacity of each centre, enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95% confidence interval will extend 0.035 from the observed proportion for an expected proportion of 0.20 based on a previous report and from our unpublished data. 2) In addition to a collection of 400 renal FMD already collected at HEGP, give sufficient power for a genome-wide association study seeking for susceptibility genes

ReferenceCitation: Arnaud C, Boulanger M, Lorthioir A, Amar L, Azarine A, Boyer L, Chatellier G, Di Monaco S, Jeunemaitre X, Kastler A, Mousseaux E, Oppenheim C, Thony F, Persu A, Olin JW, Azizi M, Touzé E; ARCADIA Co-investigators †. Male Sex Is Associated With Cervical Artery Dissection in Patients With Fibromuscular Dysplasia. J Am Heart Assoc. 2021 Jun;10(11):e018311. doi: 10.1161/JAHA.120.018311. Epub 2021 May 17.

name: Department of Neurology Inserm U1237 Normandie UniversitéUniversité Caen NormandieCHU Caen Normandie Caen France

family: Arnaud

full_name: Charlotte Arnaud

given: Charlotte

family: Boulanger

full_name: Marion Boulanger

given: Marion

name: Hypertension Unit Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges PompidouUniversité de Paris France

family: Lorthioir

full_name: Aurélien Lorthioir

given: Aurélien

family: Amar

full_name: Laurence Amar

given: Laurence

name: Department of Radiology Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges PompidouUniversité de Paris France

family: Azarine

full_name: Arshid Azarine

given: Arshid

name: Department of Radiology CHU Clermont‐Ferrand, Hopital Gabriel Montpied Clermont Ferrand France

family: Boyer

full_name: Louis Boyer

given: Louis

name: Clinical Research Unit Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges Pompidou Paris France

family: Chatellier

full_name: Gilles Chatellier

given: Gilles

name: Division of Internal Medicine and Hypertension Unit Department of Medical Sciences University of Turin Italy

name: Pole of Cardiovascular Research Institut de Recherche Expérimentale et Clinique Université Catholique de Louvain Brussels Belgium

name: Division of Cardiology Cliniques Universitaires Saint‐LucUniversité Catholique de Louvain Brussels Belgium

family: Di Monaco

full_name: Silvia Di Monaco

given: Silvia

name: Department of Genetics Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges PompidouUniversité de Paris France

family: Jeunemaitre

full_name: Xavier Jeunemaitre

given: Xavier

name: Department of Radiology CHU de Grenoble France

family: Kastler

full_name: Adrian Kastler

given: Adrian

family: Mousseaux

full_name: Elie Mousseaux

given: Elie

name: Department of Radiology and INSERM U1266 GHU Paris Psychiatry and Neurosciences Université de Paris France

family: Oppenheim

full_name: Catherine Oppenheim

given: Catherine

family: Thony

full_name: Frédéric Thony

given: Frédéric

family: Persu

full_name: Alexandre Persu

given: Alexandre

name: Zena and Michael A. Wiener Cardiovascular Institute and Marie‐Josée and Henry R. Kravis Center for Cardiovascular Health Icahn School of Medicine at Mount Sinai New York NY

family: Olin

full_name: Jeffrey W. Olin

given: Jeffrey W.

family: Azizi

full_name: Michel Azizi

given: Michel

family: Touzé

full_name: Emmanuel Touzé

given: Emmanuel

family: Chedid

full_name: Antoine Chedid

given: Antoine

family: Fiquet

full_name: Béatrice Fiquet

given: Béatrice

journal_name: Journal of the American Heart Association

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

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

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Plouin PF, Baguet JP, Thony F, Ormezzano O, Azarine A, Silhol F, Oppenheim C, Bouhanick B, Boyer L, Persu A, Hammer F, Gosse P, Mounier-Vehier C, Le Hello C, Jeunemaitre X, Azizi M, Amar L, Chatellier G, Mousseaux E, Touzé E; ARCADIA Investigators. High Prevalence of Multiple Arterial Bed Lesions in Patients With Fibromuscular Dysplasia: The ARCADIA Registry (Assessment of Renal and Cervical Artery Dysplasia). Hypertension. 2017 Sep;70(3):652-658. doi: 10.1161/HYPERTENSIONAHA.117.09539. Epub 2017 Jul 17.

name: Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit (P.-F.P., M.A., L.A.); Department of Radiology (A.A., E.M.), Department of Genetics (X.J.), and Department of Clinical Epidemiology (G.C.); INSERM CIC1418, Paris (M.A., G.C.); Department of Neurology (C.O.) and INSERM U894, Hôpital Sainte-Anne (C.O.), Paris; Faculté de Médecine, Université Paris-Descartes (P.-F.P., M.A., L.A., A.A., E.M., X.J., G.C., C.O.); Department of Cardiology, CHU de Grenoble (J.-P.B.,...