ReferenceCitation: Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, García Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592-3603. doi: 10.1200/JCO.20.00505. Epub 2020 Aug 11.

name: University of Colorado Cancer Center, Aurora, CO

family: Camidge

full_name: D. Ross Camidge

given: D. Ross

name: Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea

family: Kim

full_name: Hye Ryun Kim

given: Hye Ryun

name: Samsung Medical Center, Seoul, South Korea

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

name: National Taiwan University Hospital, Taipei, Taiwan

family: Yang

full_name: James C. H. Yang

given: James C. H.

name: National Cancer Center, Goyang, South Korea

family: Han

full_name: Ji-Youn Han

given: Ji-Youn

name: Department of Respiratory and Critical Care Medicine, Krankenhaus Nord–Klinik Floridsdorf, Vienna, Austria

family: Hochmair

full_name: Maximilian J. Hochmair

given: Maximilian J.

name: Chungbuk National University Hospital, Cheongju, South Korea

family: Lee

full_name: Ki Hyeong Lee

given: Ki Hyeong

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy

family: Delmonte

full_name: Angelo Delmonte

given: Angelo

name: Complejo Hospitalario Universitario A Coruna, Coruna, Spain

family: García Campelo

full_name: Maria Rosario García Campelo

given: Maria Rosario

name: Seoul National University Hospital, Seoul, South Korea

full_name: Dong-Wan Kim

given: Dong-Wan

name: Pius-Hospital Oldenburg, University of Oldenburg, Oldenburg, Germany

family: Griesinger

full_name: Frank Griesinger

given: Frank

name: Vall d’Hebron University Hospital, Barcelona, Spain

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

name: The Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom

family: Califano

full_name: Raffaele Califano

given: Raffaele

name: Virginia Cancer Specialists and US Oncology Research, The Woodlands, TX

family: Spira

full_name: Alexander Spira

given: Alexander

family: Gettinger

full_name: Scott N. Gettinger

given: Scott N.

name: University Hospital of Parma, Parma, Italy

family: Tiseo

full_name: Marcello Tiseo

given: Marcello

name: Millennium Pharmaceuticals, Cambridge, MA

family: Lin

full_name: Huamao M. Lin

given: Huamao M.

family: Gupta

full_name: Neeraj Gupta

given: Neeraj

family: Hanley

full_name: Michael J. Hanley

given: Michael J.

family: Ni

full_name: Quanhong Ni

given: Quanhong

family: Zhang

full_name: Pingkuan Zhang

given: Pingkuan

name: Royal Marsden Hospital, London, United Kingdom

name: The Institute of Cancer Research, London, United Kingdom

family: Popat

full_name: Sanjay Popat

given: Sanjay

journal_name: Journal of Clinical Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: American Society of Clinical Oncology (ASCO)

title: Brigatinib Versus Crizotinib in Advanced ALK Inhibitor–Naive ALK-Positive Non–Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial

ReferenceCitation: Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2027-2039. doi: 10.1056/NEJMoa1810171. Epub 2018 Sep 25.

name: From the University of Colorado Cancer Center, Aurora (D.R.C.); Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine (H.R.K.), Samsung Medical Center (M.-J.A.), and Seoul National University Hospital (D.-W.K.), Seoul, National Cancer Center, Goyang (J.-Y.H.), Seoul National University Bundang Hospital, Seongnam (J.-S.L.), and Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju (K.H.L.) —...

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

title: Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10.

title: J-ALEX: alectinib versus crizotinib in ALK -positive lung cancer

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Italy
Austria
United States
Luxembourg
Sweden
Hong Kong
Netherlands
Switzerland
Germany
France
Norway
Singapore
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Studiengesellschaft Haemato-Onkologie Hamburg Prof. Laack und Partner

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita

location_facility: Hospital Teresa Herrera - Materno Infantil

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia

location_facility: Hospital Universitario Central de Asturias

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centre Hospitalier de Luxembourg - Hopital Municipal

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Amphia Ziekenhuis - Locatie Langendijk Breda

location_facility: Hospital Regional Universitario Carlos Haya Malaga Instituto de Neurociencias Clinicas

location_facility: Hospital General Universitario de Alicante

location_facility: Istituto Oncologico di Bari Giovanni Paolo II

location_facility: Kaiser Permanente Bellflower Medical Offices

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim

location_facility: Istituto Tumori Napoli Fondazione G. Pascale

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Virginia Cancer Specialists - Fairfax Office

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: USOR - Arizona Oncology Associates - Sedona

location_facility: Centre Hospitalier Universitaire Hopital Nord

title: A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer

summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).


title: TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)

acronym: NSCLC

summary: The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Clovis Oncology, Inc.

location_country:
United States
Hong Kong
Netherlands
Switzerland
Germany
France
Australia
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: University of California San Diego Moores Cancer Center

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: University of California Davis Medical Center

location_facility: Washington University School of Medicine

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Universitaire Hôpital Nord

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

location_facility: Centre Hospitalier Universitaire Vaudoise

location_facility: Yakima Valley Memorial Hospital, North Star Lodge

location_facility: Centre Hospitalier Universitaire Côte de Nacre

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.

acronym: THIF

summary: The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.

status: Completed

ReferenceType: derived

ReferenceCitation: Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.

family: Zufferey

full_name: P.J. Zufferey

sequence: first

family: Miquet

full_name: M. Miquet

given: M.

sequence: additional

family: Quenet

full_name: S. Quenet

given: S.

family: Martin

full_name: P. Martin

given: P.

family: Adam

full_name: P. Adam

family: Albaladejo

full_name: P. Albaladejo

family: Mismetti

full_name: P. Mismetti

family: Molliex

full_name: S. Molliex

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Anaesthesia

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

lead_sponsor_type: academique

status_simplified: Completed


title: Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases

summary:
Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST] criteria).

Secondary Objectives:

This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months (stabilization or objective response, RECIST criteria) and that of response observed after 6 months of treatment.
The organisational objective is to develop a tumour bank of metastatic colorectal cancer.

Population: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease.

Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue); molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]); and biology and pathology on microbiopsy of liver metastasis are used.

Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.

Studied Factors:

Radiology:

CT scan: RECIST criteria (gold standard);
Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit).

Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])

Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms

Statistics:

Descriptive analyses;
Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months

Analysis of prognostic factors:

Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
Multivariate analysis of prognostic factors;
Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.

design_allocation: Non-Randomized

lead_sponsor: Hospices Civils de Lyon


title: Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.

summary: Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. We assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Effect of an Intensive Insulin Therapy on the Production of LTE4 in Patients With Diabetes

summary: The primary objective of the study is to assess the effect of a 3-month intensive insulin therapy on urinary leukotriene E4 (LTE4) excretion in patients with diabetes.

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Hardy G, Boizel R, Bessard J, Cracowski JL, Bessard G, Halimi S, Stanke-Labesque F. Urinary leukotriene E4 excretion is increased in type 1 diabetic patients: a quantification by liquid chromatography-tandem mass spectrometry. Prostaglandins Other Lipid Mediat. 2005 Dec;78(1-4):291-9. Epub 2005 Nov 2.

ReferenceCitation: Hardy G, Vergnaud S, Lunardi J, Peoc'h M, Bessard G, Stanke-Labesque F. 5-lipoxygenase expression and activity in aorta from streptozotocin-induced diabetic rats. Prostaglandins Other Lipid Mediat. 2005 Jan;75(1-4):91-103.

ReferenceCitation: Cipollone F, Mezzetti A, Fazia ML, Cuccurullo C, Iezzi A, Ucchino S, Spigonardo F, Bucci M, Cuccurullo F, Prescott SM, Stafforini DM. Association between 5-lipoxygenase expression and plaque instability in humans. Arterioscler Thromb Vasc Biol. 2005 Aug;25(8):1665-70. Epub 2005 Jun 2.

ReferenceCitation: Dwyer JH, Allayee H, Dwyer KM, Fan J, Wu H, Mar R, Lusis AJ, Mehrabian M. Arachidonate 5-lipoxygenase promoter genotype, dietary arachidonic acid, and atherosclerosis. N Engl J Med. 2004 Jan 1;350(1):29-37.

ReferenceCitation: Helgadottir A, Manolescu A, Thorleifsson G, Gretarsdottir S, Jonsdottir H, Thorsteinsdottir U, Samani NJ, Gudmundsson G, Grant SF, Thorgeirsson G, Sveinbjornsdottir S, Valdimarsson EM, Matthiasson SE, Johannsson H, Gudmundsdottir O, Gurney ME, Sainz J, Thorhallsdottir M, Andresdottir M, Frigge ML, Topol EJ, Kong A, Gudnason V, Hakonarson H, Gulcher JR, Stefansson K. The gene encoding 5-lipoxygenase activating protein confers risk of myocardial infarction and stroke. Nat Genet. 2004 Mar;36(3):233-9. Epub 2004 Feb 8.

ReferenceCitation: Boizel R, Bruttmann G, Benhamou PY, Halimi S, Stanke-Labesque F. Regulation of oxidative stress and inflammation by glycaemic control: evidence for reversible activation of the 5-lipoxygenase pathway in type 1, but not in type 2 diabetes. Diabetologia. 2010 Sep;53(9):2068-70. doi: 10.1007/s00125-010-1822-9. Epub 2010 Jun 10.

family: Boizel

full_name: R. Boizel

given: R.

family: Bruttmann

full_name: G. Bruttmann

given: G.

family: Benhamou

full_name: P. Y. Benhamou

given: P. Y.

family: Halimi

full_name: S. Halimi

family: Stanke-Labesque

full_name: F. Stanke-Labesque

given: F.

journal_name: Diabetologia

evidence: open (via free pdf)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: University Hospital, Grenoble

location_facility: Département d'urologie, néphrologie et endocrinologie-University Hospital of Grenoble


title: Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.

acronym: TOTEM

summary: This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg [FTC/TDF]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.

ReferenceCitation: Valantin MA, Bittar R, de Truchis P, Bollens D, Slama L, Giral P, Bonnefont-Rousselot D, Pétour P, Aubron-Olivier C, Costagliola D, Katlama C; TOTEM trial group. Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients. J Antimicrob Chemother. 2010 Mar;65(3):556-61. doi: 10.1093/jac/dkp462. Epub 2010 Jan 6.

family: Valantin

full_name: M. A. Valantin

given: M. A.

family: Bittar

full_name: R. Bittar

family: de Truchis

full_name: P. de Truchis

family: Bollens

full_name: D. Bollens

given: D.

family: Slama

full_name: L. Slama

given: L.

family: Giral

full_name: P. Giral

family: Bonnefont-Rousselot

full_name: D. Bonnefont-Rousselot

family: Petour

full_name: P. Petour

family: Aubron-Olivier

full_name: C. Aubron-Olivier

given: C.

family: Costagliola

full_name: D. Costagliola

family: Katlama

full_name: C. Katlama

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Gilead Sciences


title: A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy

summary: Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

ReferenceCitation: Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.

lead_sponsor: Norgine

location_facility: Hôpital Lariboisière, Endoscopy Department


title: Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial

acronym: SCLEREDUC

summary: Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.

name: AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153; Paris France

family: Rannou

full_name: François Rannou

given: François

name: AP-HP Hôtel Dieu Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153; Paris France

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

name: Reference Center for Rare Diseases, AP-HP Cochin Hospital, and Université Paris Descartes Sorbonne Paris Cité; Paris France

family: Mouthon

full_name: Luc Mouthon

given: Luc

family: Sanchez

full_name: Katherine Sanchez

given: Katherine

name: Reference Center for Rare Diseases, Lille University Medical Center, University of Lille 2; Lille France

family: Tiffreau

full_name: Vincent Tiffreau

given: Vincent

family: Hachulla

full_name: Eric Hachulla

given: Eric

name: AP-HP Rothschild Hospital and Pierre and Marie Curie University; Paris France

family: Thoumie

full_name: Philipe Thoumie

given: Philipe

name: AP-HP Saint-Antoine Hospital and Pierre and Marie Curie University; Paris France

family: Cabane

full_name: Jean Cabane

given: Jean

name: Hôpital Hautepierre, Fédération de Médecine Translationnelle de Strasbourg, UMR INSERM 1109, Université de Strasbourg-Hôpitaux Universitaires de Strasbourg; Strasbourg France

family: Chatelus

full_name: Emmanuel Chatelus

given: Emmanuel

family: Sibilia

full_name: Jean Sibilia

family: Roren

full_name: Alexandra Roren

given: Alexandra

family: Berezne

full_name: Alice Berezne

given: Alice

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Porcher

full_name: Raphael Porcher

given: Raphael

family: Guillevin

full_name: Loic Guillevin

given: Loic

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Poiraudeau

full_name: Serge Poiraudeau

given: Serge

journal_name: Arthritis Care & Research

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Daste C, Rannou F, Mouthon L, Sanchez K, Roren A, Tiffreau V, Hachulla É, Thoumie P, Cabane J, Chatelus E, Sibilia J, Poiraudeau S, Nguyen C. Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care. Semin Arthritis Rheum. 2019 Feb;48(4):694-700. doi: 10.1016/j.semarthrit.2018.03.013. Epub 2018 Mar 27.

family: Daste

full_name: Camille Daste

given: Camille


title: Effect of Obstructive Sleep Apnea Syndrome Associated With Obesity on Cough Reflex Threshold to Citric Acid

summary: Up to 70% of obese patients undergoing bariatric surgery have obstructive sleep apnea syndrome (OSAS). OSAS is responsible for laryngeal sensory impairment. As the afferent neural pathway involved in the initiation of cough is located in the laryngeal epithelium, cough reflex sensitivity may be decreased in obese OSAS patients. The researchers therefore conducted this study to determine the effect of OSAS associated with obesity on cough reflex sensitivity, assessed by cough reflex threshold to an inhaled irritant (citric acid).

ReferenceCitation: Nguyen AT, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ. Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep. 2005 May;28(5):585-93.

lead_sponsor: Bichat Hospital

location_facility: Anesthesiology Department, Bichat Hospital


title: Evaluation of the Impact of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on the Development of Acute Renal Failure in Critically Ill Patients

summary: Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: du Cheyron D, Fradin S, Ramakers M, Terzi N, Guillotin D, Bouchet B, Daubin C, Charbonneau P. Angiotensin converting enzyme insertion/deletion genetic polymorphism: its impact on renal function in critically ill patients. Crit Care Med. 2008 Dec;36(12):3178-83. doi: 10.1097/CCM.0b013e318186a299.

family: du Cheyron

full_name: Damien du Cheyron

given: Damien

family: Fradin

full_name: Sabine Fradin

given: Sabine

family: Ramakers

full_name: Michel Ramakers

given: Michel

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

family: Guillotin

full_name: Damien Guillotin

family: Bouchet

full_name: Bruno Bouchet

given: Bruno

family: Daubin

full_name: Cédric Daubin

given: Cédric

family: Charbonneau

full_name: Pierre Charbonneau

given: Pierre

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Angiotensin converting enzyme insertion/deletion genetic polymorphism: Its impact on renal function in critically ill patients*

lead_sponsor: University Hospital, Caen

location_facility: Medical Intensive care Unit; Caen University Hospital


title: Comparison of Data Obtained by Echocardiography and Magnetic Resonance Imaging in Hypertrophic Cardiomyopathy

summary: Compare data (structural and functional) obtained by transthoracic rest echocardiography and magnetic resonance imaging (with gadolinium) in 30 patients with hypertrophic cardiomyopathy

status: Unknown status

time_perspective: Other


title: Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.

summary: Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.

study_completion_date_type: Anticipated

ReferenceCitation: Dunlop SP, Spiller RC. Nutritional issues in irritable bowel syndrome. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):537-40. Review.

ReferenceCitation: Francis CY, Whorwell PJ. Bran and irritable bowel syndrome: time for reappraisal. Lancet. 1994 Jul 2;344(8914):39-40.

ReferenceCitation: Harmsen HJ, Raangs GC, He T, Degener JE, Welling GW. Extensive set of 16S rRNA-based probes for detection of bacteria in human feces. Appl Environ Microbiol. 2002 Jun;68(6):2982-90.

ReferenceCitation: Jones R, Lydeard S. Irritable bowel syndrome in the general population. BMJ. 1992 Jan 11;304(6819):87-90.

ReferenceCitation: Jones VA, McLaughlan P, Shorthouse M, Workman E, Hunter JO. Food intolerance: a major factor in the pathogenesis of irritable bowel syndrome. Lancet. 1982 Nov 20;2(8308):1115-7.

ReferenceCitation: King TS, Elia M, Hunter JO. Abnormal colonic fermentation in irritable bowel syndrome. Lancet. 1998 Oct 10;352(9135):1187-9.

ReferenceCitation: Snook J, Shepherd HA. Bran supplementation in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 1994 Oct;8(5):511-4.

ReferenceCitation: Tarrerias AL, Millecamps M, Alloui A, Beaughard C, Kemeny JL, Bourdu S, Bommelaer G, Eschalier A, Dapoigny M, Ardid D. Short-chain fatty acid enemas fail to decrease colonic hypersensitivity and inflammation in TNBS-induced colonic inflammation in rats. Pain. 2002 Nov;100(1-2):91-7.

ReferenceCitation: Bourdu S, Dapoigny M, Chapuy E, Artigue F, Vasson MP, Dechelotte P, Bommelaer G, Eschalier A, Ardid D. Rectal instillation of butyrate provides a novel clinically relevant model of noninflammatory colonic hypersensitivity in rats. Gastroenterology. 2005 Jun;128(7):1996-2008.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment

acronym: ATACA

summary: The objective of this study is to determine if concentrations of amiodarone in fat tissue increases constantly over time during chronic treatment with this drug, and if blood concentrations reflect accurately the concentrations in fat tissue or not. This is because excessive concentrations of this drug in tissues can produce adverse effects.

lead_sponsor: Hopital Lariboisière

location_facility: Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services


title: Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy.

summary: Lung surgery under thoracotomy is known to induce long-term pain which can be considered as neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as it is already commonly administered intra and postoperatively for improvement of analgesia [6].

ReferenceCitation: Perttunen K, Tasmuth T, Kalso E. Chronic pain after thoracic surgery: a follow-up study. Acta Anaesthesiol Scand. 1999 May;43(5):563-7.

ReferenceCitation: Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96.

ReferenceCitation: Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301.

ReferenceCitation: Felsby S, Nielsen J, Arendt-Nielsen L, Jensen TS. NMDA receptor blockade in chronic neuropathic pain: a comparison of ketamine and magnesium chloride. Pain. 1996 Feb;64(2):283-291. doi: 10.1016/0304-3959(95)00113-1.

ReferenceCitation: Burton AW, Lee DH, Saab C, Chung JM. Preemptive intrathecal ketamine injection produces a long-lasting decrease in neuropathic pain behaviors in a rat model. Reg Anesth Pain Med. 1999 May-Jun;24(3):208-13.

ReferenceCitation: De Kock M, Lavand'homme P, Waterloos H. 'Balanced analgesia' in the perioperative period: is there a place for ketamine? Pain. 2001 Jun;92(3):373-380. doi: 10.1016/S0304-3959(01)00278-0.

ReferenceCitation: Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.

ReferenceCitation: Dualé C, Sibaud F, Guastella V, Vallet L, Gimbert YA, Taheri H, Filaire M, Schoeffler P, Dubray C. Perioperative ketamine does not prevent chronic pain after thoracotomy. Eur J Pain. 2009 May;13(5):497-505. doi: 10.1016/j.ejpain.2008.06.013. Epub 2008 Sep 9.

family: Dualé

full_name: Christian Dualé

given: Christian

family: Sibaud

full_name: Fabrice Sibaud

given: Fabrice

family: Guastella

full_name: Virginie Guastella

given: Virginie

family: Vallet

full_name: Laurent Vallet

given: Laurent

family: Gimbert

full_name: Yves-Alain Gimbert

given: Yves-Alain

family: Taheri

full_name: Hammou Taheri

given: Hammou

family: Filaire

full_name: Marc Filaire

given: Marc

family: Schoeffler

full_name: Pierre Schoeffler

family: Dubray

full_name: Claude Dubray

given: Claude

journal_name: European Journal of Pain


title: Comparative Study of Duration of Respiratory Weaning Between Adaptive Support Ventilation and Succession of Controlled Ventilation Then Spontaneous Ventilation for Patients After Surgery

summary: This is a comparative study of duration of respiratory weaning between adaptive support ventilation and succession of controlled ventilation then spontaneous ventilation for patients after surgery.

ReferenceCitation: Petter AH, Chioléro RL, Cassina T, Chassot PG, Müller XM, Revelly JP. Automatic "respirator/weaning" with adaptive support ventilation: the effect on duration of endotracheal intubation and patient management. Anesth Analg. 2003 Dec;97(6):1743-1750. doi: 10.1213/01.ANE.0000086728.36285.BE.

ReferenceCitation: Sulzer CF, Chioléro R, Chassot PG, Mueller XM, Revelly JP. Adaptive support ventilation for fast tracheal extubation after cardiac surgery: a randomized controlled study. Anesthesiology. 2001 Dec;95(6):1339-45.


title: A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

acronym: SOPHIA

summary: The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

status: Active, not recruiting

ReferenceCitation: Rugo HS, Im SA, Cardoso F, Cortés J, Curigliano G, Musolino A, Pegram MD, Wright GS, Saura C, Escrivá-de-Romaní S, De Laurentiis M, Levy C, Brown-Glaberman U, Ferrero JM, de Boer M, Kim SB, Petráková K, Yardley DA, Freedman O, Jakobsen EH, Kaufman B, Yerushalmi R, Fasching PA, Nordstrom JL, Bonvini E, Koenig S, Edlich S, Hong S, Rock EP, Gradishar WJ; SOPHIA Study Group. Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):573-584. doi: 10.1001/jamaoncol.2020.7932.

name: University of California San Francisco Helen Diller Family Comprehensive Cancer Center

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

name: Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

name: Champalimaud Clinical Center/Champalimaud Foundation, Breast Unit, Lisbon, Portugal

family: Cardoso

full_name: Fatima Cardoso

given: Fatima

name: IOB Institute of Oncology, Quironsalud Group, Madrid and Barcelona, Spain

name: Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain

family: Cortés

full_name: Javier Cortés

given: Javier

name: European Institute of Oncology, IRCCS, Division of Early Drug Development, University of Milano, Milan, Italy

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

name: Department of Medicine and Surgery, University of Parma, Medical Oncology and Breast Unit, University Hospital of Parma, Parma, Italy

family: Musolino

full_name: Antonino Musolino

given: Antonino

name: Stanford Comprehensive Cancer Institute, Stanford University School of Medicine, Stanford, California

family: Pegram

full_name: Mark D. Pegram

given: Mark D.

name: Florida Cancer Specialists & Research Institute, New Port Richey

family: Wright

full_name: Gail S. Wright

given: Gail S.

name: Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), Medical Oncology Service, Barcelona, Spain

family: Saura

full_name: Cristina Saura

given: Cristina

family: Escrivá-de-Romaní

full_name: Santiago Escrivá-de-Romaní

given: Santiago

name: Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori “Fondazione Pascale”, Naples, Italy

family: De Laurentiis

full_name: Michelino De Laurentiis

given: Michelino

name: Centre François Baclesse, Institut Normand du Sein, Caen, France

family: Levy

full_name: Christelle Levy

given: Christelle

name: Division of Hematology/Oncology, University of New Mexico Comprehensive Cancer Center, Albuquerque

family: Brown-Glaberman

full_name: Ursa Brown-Glaberman

given: Ursa

name: Centre Antoine Lacassagne, Department of Medical Oncology, University Côte d’Azur, Nice, France

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

name: Maastricht University Medical Center, Division of Medical Oncology, Department of Internal Medicine, GROW-School of Oncology and Developmental Biology, Maastricht, the Netherlands

family: de Boer

full_name: Maaike de Boer

given: Maaike

name: Department of Oncology, Asan Medical Center, Seoul, Korea

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

name: Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Brno, Czech Republic

family: Petráková

full_name: Katarína Petráková

given: Katarína

name: Sarah Cannon Research Institute, Tennessee Oncology PLLC, Nashville

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

name: RS McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa, Ontario, Canada

family: Freedman

full_name: Orit Freedman

given: Orit

name: Department of Oncology, Vejle Hospital, Vejle, Denmark

family: Jakobsen

full_name: Erik H. Jakobsen

given: Erik H.

name: Chaim Sheba Medical Center, Breast Oncology Institute, Ramat Gan, Israel

family: Kaufman

full_name: Bella Kaufman

given: Bella

name: Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel

family: Yerushalmi

full_name: Rinat Yerushalmi

given: Rinat

name: Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany

family: Fasching

full_name: Peter A. Fasching

given: Peter A.

name: Division of Hematology/Oncology, Northwestern University, Chicago, Illinois

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

location_country:
Italy
Austria
United States
Netherlands
Spain
Germany
Finland
France
Czechia
Poland
Israel
Belgium
Puerto Rico
Portugal
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Saint Barnabas Medical Center - The Cancer Center

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

location_facility: Clalit Health Services - Lin Medical Center

location_facility: Wake Forest University Baptist Medical Center (WFUBMC)

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

location_facility: Kent Oncology Centre, Maidstone Hospital

location_facility: Centro Clínico Champalimaud/Fundação Champalimaud

location_facility: H. Santa Maria - Centro Hospitalar Lisboa Norte

location_facility: CTCA - Midwestern Regional Medical Center

location_facility: PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona

location_facility: Hospital Universitario Clínico San Carlos

location_facility: New Jersey Hematology Oncology Associates

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli

location_facility: CTCA - Eastern Regional Medical Center, Inc.

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: Regionshospitalet Herning (Herning Centralsygehus)

location_facility: AO S.Andrea, Università degli Studi di Roma La Sapienza

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: New York University Clinical Cancer Center

location_facility: University of California, San Francisco Helen Diller Family Comprehensive Cancer Center

location_facility: Helsinki University Central Hospital (HUCH) - Meilahden Sair

location_facility: Istituto Europeo di Oncologia Via Ripamonti

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: The Center for Cancer and Blood Disorders

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: University of Washington/ Seattle Cancer Care Alliance

location_facility: Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori

location_facility: The Chaim Sheba Medical Center - Insititute of Oncology

location_facility: CTCA - Southeastern Regional Medical Center

location_facility: Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: ASST Papa Giovanni XXIII - Oncologia-Bergamo

location_facility: Azienda Ospedaliero Universitaria Senese Universita degli St

location_facility: University of Texas Southwestern Medical Center


title: SyncAV Post-Market Trial

acronym: SyncAV

summary: The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.

status: Recruiting

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country:
Finland
Australia
Belgium
Russian Federation
Taiwan
India
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Colombia
Sweden
United Arab Emirates
Saudi Arabia
Hong Kong
Switzerland
Singapore
Puerto Rico
Portugal
China
United States
Germany
United Kingdom
Italy
Austria
Serbia
Spain

location_facility: McGill University Health Centre General Hospital

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: Cardiac Arrhythmia Research Group Inc. (CARGI)

location_facility: Klinikum der Ruprecht-Karls-Universität Heidelberg

location_facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera Universitaria MaterDomini

location_facility: Helsinki University Central Hospital (HYKS)

location_facility: The University of Hong Kong (Queen Mary Hospital)

location_facility: Washington University School of Medicine

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Hospital Puerta de Hierro - Hospital Universitario

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: New York Presbyterian Brooklyn Methodist Hospital

location_facility: Clinical Center of Serbia - Pacemaker Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Meshalkin National Medical Research Center

location_facility: Narayana Institute of Cardiac Sciences, Bommasandra

intervention_type: Device

status_simplified: Ongoing


title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies

summary: The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.


title: Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions

summary: In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas

ReferenceCitation: Brauner R, Serreau R, Souberbielle JC, Pouillot M, Grouazel S, Recasens C, Zerah M, Sainte-Rose C, Treluyer JM. Diazoxide in Children With Obesity After Hypothalamic-Pituitary Lesions: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Dec;101(12):4825-4833. Epub 2016 Sep 7.


title: Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").

acronym: CMD-scanner

summary: Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary angiography.

lead_sponsor: Rennes University Hospital

location_facility: Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou


lead_sponsor: Takeda

location_country:
Finland
Greece
Romania
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Bulgaria
China
United States
Italy
Austria
Brazil
Mexico
Belarus
Spain
Turkey

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: City Clinical Hospital No. 52 of the Moscow Healthcare Department

location_facility: City Clinical Hospital named after Vikentiy Vikentyevich Veresaev

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: HEMORIO Instituto Estadual de Hematologia

location_facility: Centre Hospitalier de Versailles Hopital Andre Mignot

location_facility: Republican Scientific and Practical Center of Children's Oncology, Hematology and Immunology

location_facility: General Hospital of Thessaloniki George Papanikolaou

location_facility: Hanusch Krankenhaus Wiener Gebietskrankenkasse

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Eurolatino Juiz de Fora Pesquisas Medicas

location_facility: Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Minsk Scientific and Practical Center of Surgery, Transplantation and Haematology

location_facility: The First Affiliated Hospital of Soochow University/Suzhou First People's Hospital

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Daegu Catholic University Medical Center

location_facility: Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Helsingin ja Uudenmaan sairaanhoitopiiri

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Uniwersytecki Szpital Kliniczny we Wroclawiu

location_facility: Samodzielny Publiczny Szpital Kliniczny Number 1 w Lublinie

location_facility: University General Hospital of Heraklion Panepistimiako Geniko Nosokomeio Irakleiou

location_facility: Augusta University Georgia Cancer Center

location_facility: Universitaetsklinik Fuer Innere Medizin I

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Republican Research Centre for Radiation Medicine and Human Ecology

location_facility: Centro di Ematologia Policlinico Umberto I Universita Sapienza di Roma

location_facility: General Hospital of Athens G. Gennimatas

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University General Hospital of Patras Panagia I Voithia

location_facility: Institute of Hematology & Blood Diseases Hospital of CAMS & PUMC

location_facility: Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: National Research Center for Hematology, Dept. of Hematology/Oncology and BMT

location_facility: University of Kansas Medical Center Research Institute

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie - Oddzial w Gliwicach

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: University Multiprofile Hospital for Active Treatment Saint Ivan Rilski

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurs

location_facility: University General Hospital of Athens Attikon

location_facility: Instituto do Cancer do Estado de Sao Paulo

location_facility: Fundacao Antonio Prudente - A.C.Camargo Cancer Center

ipd_sharing: Yes

type: EudraCT Number

type: Other Identifier

type: Registry Identifier

source: euctr

title: A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

summary:
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib.

The main aim of this study is to compare the number of participants on each treatment that show no signs of disease.

Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.


title: Oral Tolerance in Cow's Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora

summary:
This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others.

Cow's milk allergy is evaluated by basophils activation test, T cells activation test, specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month avoiding food, before and after low dose milk exposure, before and after oral challenge.

Number and function of regulatory T cells and microflora composition are measured at the same time.

Allergic infants are compared to age matched control group.


title: A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

summary: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

ReferenceCitation: Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2). pii: e002015. doi: 10.1136/jitc-2020-002015.

family: Luke

full_name: Jason J Luke

given: Jason J

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Chung

full_name: Ki Chung

given: Ki

family: Tolcher

full_name: Anthony W Tolcher

given: Anthony W

family: Kelly

full_name: Karen Kelly

given: Karen

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

family: Subbiah

full_name: Vivek Subbiah

given: Vivek

family: Tsai

full_name: Frank Tsai

given: Frank

family: Kao

full_name: Steven Kao

given: Steven

family: Cassier

full_name: Philippe A Cassier

given: Philippe A

family: Khasraw

full_name: Mustafa Khasraw

given: Mustafa

family: Kindler

full_name: Hedy L Kindler

given: Hedy L

family: Fang

full_name: Hua Fang

given: Hua

family: Fan

full_name: Frances Fan

given: Frances

family: Allaire

full_name: Kathryn Allaire

given: Kathryn

family: Patel

full_name: Maulik Patel

given: Maulik

family: Ye

full_name: Shiming Ye

given: Shiming

family: Chao

full_name: Debra T Chao

given: Debra T

family: Henner

full_name: William R Henner

given: William R

family: Hayflick

full_name: Joel S Hayflick

given: Joel S

family: McDevitt

full_name: Michael A McDevitt

given: Michael A

family: Fong

full_name: Lawrence Fong

given: Lawrence

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 154441

location_facility: UC Davis Comprehensive Cancer Center - Main /ID# 154439

location_facility: South Texas Accelerated Research Therapeutics /ID# 154442

location_facility: HonorHealth Research Institute - Pima /ID# 155461


title: One-year Double-blind Placebo-controlled Phase 2-3 Study to Evaluate the Effect of Oral Folinic Acid Treatment (1mg/kg/d) on the Psychomotor Development of Young Down Syndrome Patients

summary: The purpose of this study is to determine whether folinic acid can improve developmental quotient of young Down syndrome patients, given that these present signs of folate deficiency which are known to cause reversible neurological, psychiatric and cognitive disorders.

ReferenceCitation: Botez MI, Botez T, Leveille J, Bielmann P, Cadotte M. Neuropsychological correlates of folic acid deficiency: facts and hypotheses. In: Botez MI, Reynolds EH, eds. Folic acid in neurology, psychiatry and internal medicine. New York, Raven Press, 1979:435-461.

ReferenceCitation: Lejeune J. [Pathogenesis of mental impairment in trisomy 21]. Ann Genet. 1991;34(2):55-64. Review. French.

ReferenceCitation: Blehaut H, Mircher C, Ravel A, Conte M, de Portzamparc V, Poret G, de Kermadec FH, Rethore MO, Sturtz FG. Effect of leucovorin (folinic acid) on the developmental quotient of children with Down's syndrome (trisomy 21) and influence of thyroid status. PLoS One. 2010 Jan 11;5(1):e8394. doi: 10.1371/journal.pone.0008394.

family: Blehaut

full_name: Henri Blehaut

given: Henri

family: Mircher

full_name: Clotilde Mircher

given: Clotilde

family: Ravel

full_name: Aimé Ravel

given: Aimé

family: Conte

full_name: Martine Conte

given: Martine

family: de Portzamparc

full_name: Veronique de Portzamparc

given: Veronique

family: Poret

full_name: Gwendael Poret

given: Gwendael

family: Huon de Kermadec

full_name: Françoise Huon de Kermadec

given: Françoise

family: Rethore

full_name: Marie-Odile Rethore

given: Marie-Odile

family: Sturtz

full_name: Franck G. Sturtz

given: Franck G.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

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

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Effect of Leucovorin (Folinic Acid) on the Developmental Quotient of Children with Down's Syndrome (Trisomy 21) and Influence of Thyroid Status

lead_sponsor: Institut Jerome Lejeune


title: Clinico-biological Study/Characterization of Rhabdomyosarcoma in AYA (Adolescents and Young Adults, 15-25-year-old Patients)

summary:
Rhabdomyosarcoma (RMS) stands for the most frequent soft tissue sarcoma in children and, adolescents and young adults (AYA, 15-25-year-old population), accounting for approximately half of the whole soft tissue sarcomas in these populations.. Conversely, RMS represents a very small proportion of the soft tissue sarcomas in adults (3%), that is less than 1% of all solid cancers of adults.

To date, previous studies undertaken among the paediatric population have pointed out several prognostic factors such as tumor localisation, tumor invasiveness at diagnosis, tumor size, histological subset, and treatment plans. Age at diagnosis remains an independent prognostic factor.

RMS management is consensual in Europe for paediatric population, essentially based on the protocol RMS 2005 within the framework of the European Paediatric Soft tissue sarcoma Study Group (EpSSG). Care in AYAs remain heterogeneous and are either achieved in paediatric department, according to EpSSG guidelines, or in oncology department, known as "adult unit", depending on ESMO (European Society for Medical Oncology), which are non-specific recommendations for the management of rhabdomyosarcoma.

No consensus has been published yet for RMS in AYA despite the growing interest in cancers in AYA population - topic.supported by the French National Cancer Institute (INCa) - and the increasing network between paediatricians and adult-oncologists. Thus management of RMS in AYA remains patchy/unequal depending on the type of care unit.

Herein, with the support of the Oscar Lambret Center, we aim at assessing and identifying clinico-biological prognostic factors of rhabdomyosarcoma in AYA. Eventually, we hope to offer a standardized treatment to this population. Data collected from medical file will be anonymised in a confidential database of which the recipient is the sponsor of the study.

The ancillary study will aim at characterizing the molecular profile of the difficult-to-classify RMS subtypes (fusiform or pleomorphic subsets) in molecular biology for ambiguous cases.

From a scientific point of view, this study aims at understanding the parameters that may influence the prognosis of RMS in AYAs by evaluating various clinical and biological factors.

Biologically, molecular profiling of RMS in AYA may improve the characterization of this tumour in this age group.

At the clinical level, the completeness of the data collected will lead to a better description of RMS in AYAs. We hope to harmonize their therapeutic management by providing therapeutic adjustments according to population subsets.

Finally, these results could also help to adapt the therapeutic management of AYAs within the framework of the European protocol that is currently under construction, and will involve both children and adults.

time_perspective: Retrospective

lead_sponsor: Centre Oscar Lambret

location_facility: TOURS CHU-Bretonneau/Hôp G de Clocheville

location_facility: NANCY Institut de Cancérologie de Lorraine

location_facility: NANTES Institut de Cancérologie de l'Ouest

location_facility: LILLE Centre Oscar Lambret/ CHRU de Lille


title: Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Effect of a 30-week Caffeine Treatment on Cognition in Alzheimer's Disease at Beginning to Moderate Stages

acronym: CAFCA

summary:
Sporadic Alzheimer's disease is a multifactorial illness arising a major medico-economic stakes for our aging societies. There is currently no curative treatment available.

Coffee is a complex beverage with psychostimulant properties whose main effective element, caffeine, has a pleiotropic effect on the central nervous system. Caffeine pharmacological properties enable its use like an Alzheimer's disease symptomatic treatment. Its supposed benefits mustn't obscure anxiety and insomnia caffeine effect at large dose, which Alzheimer's patients might be more vulnerable.

The main study objective is to evaluate placebo-controlled caffeine efficacy (30 treatments weeks) on cognitive decline in Alzheimer's disease dementia at beginning to moderate stage (MMSE 16-24).

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Lille

location_facility: CHU Lille consultation mémoire Les Bâteliers


title: Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns

summary: Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.

ReferenceCitation: Bourdon A, Rougé C, Legrand A, Des Robert C, Piloquet H, Vodovar M, Voyer M, Rozé JC, Darmaun D. Urinary citrulline in very low birth weight preterm infants receiving intravenous nutrition. Br J Nutr. 2012 Oct;108(7):1150-4. Epub 2011 Dec 12.

ReferenceCitation: Rougé C, Piloquet H, Butel MJ, Berger B, Rochat F, Ferraris L, Des Robert C, Legrand A, de la Cochetière MF, N'Guyen JM, Vodovar M, Voyer M, Darmaun D, Rozé JC. Oral supplementation with probiotics in very-low-birth-weight preterm infants: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jun;89(6):1828-35. doi: 10.3945/ajcn.2008.26919. Epub 2009 Apr 15.

family: Rougé

full_name: Carole Rougé

given: Carole

family: Piloquet

full_name: Hugues Piloquet

given: Hugues

family: Butel

full_name: Marie-José Butel

given: Marie-José

family: Berger

full_name: Bernard Berger

given: Bernard

family: Rochat

full_name: Florence Rochat

given: Florence

family: Ferraris

full_name: Laurent Ferraris

given: Laurent

family: Des Robert

full_name: Clotilde Des Robert

family: Legrand

full_name: Arnaud Legrand

given: Arnaud

family: de la Cochetière

full_name: Marie-France de la Cochetière

given: Marie-France

family: N’Guyen

full_name: Jean-Michel N’Guyen

given: Jean-Michel

family: Vodovar

full_name: Michel Vodovar

given: Michel

family: Voyer

full_name: Marcel Voyer

given: Marcel

family: Darmaun

full_name: Dominique Darmaun

given: Dominique

family: Rozé

full_name: Jean-Christophe Rozé

given: Jean-Christophe

journal_name: The American Journal of Clinical Nutrition

lead_sponsor: Nantes University Hospital

intervention_type: Dietary Supplement


title: Evaluation of Safety and Performance of Macroporous Biphasic Calcium Phosphate Granules Combined With Cellulosic-Derived Gel, in Filling Bones Gap After Aseptic Osteonecrosis Biopsy of Femur Head.

summary: The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.

lead_sponsor: Biomatlante

location_facility: Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin


title: Working Memory Updating in Posttraumatic Stress Disorder (PTSD): Study of Neural Correlates Using fMRI

acronym: METRAPI

summary: Neuropsychological studies investigating trauma-exposed and posttraumatic stress disorder (PTSD) subjects have generally underlined the significantly poorer performance of tasks that require attention, concentration, and verbal memory, and difficulty in regulating memories surrounding the traumatic event. A previous study (El Hage et al. Cognitive Neuropsychiatry, 2006) revealed that the trauma-exposed subjects scored higher on anxiety/depression scales, and lower on processing speed tests. Moreover, the study showed significant impairment in working memory partially mediated by speed processing, but not by anxiety or depression. These results suggest that processing speed makes a major contribution to trauma-related working memory decline, and needs to be investigated in further studies.The aim of the present study is to explore correlation between hippocampus volume, frontal dysfunction and cognitive slowing in trauma-exposed subjects, while examining brain activation during performance of working memory tasks using functional magnetic resonance.

time_perspective: Cross-Sectional

ReferenceCitation: El-Hage W, Gaillard P, Isingrini M, Belzung C. Trauma-related deficits in working memory. Cogn Neuropsychiatry. 2006 Jan;11(1):33-46.

lead_sponsor: University Hospital, Tours


ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

family: Hattinger

full_name: Claudia Maria Hattinger

given: Claudia Maria

family: Patrizio

full_name: Maria Pia Patrizio

given: Maria Pia

family: Magagnoli

full_name: Federica Magagnoli

given: Federica

family: Luppi

full_name: Silvia Luppi

given: Silvia

family: Serra

full_name: Massimo Serra

given: Massimo

journal_name: Expert Opinion on Emerging Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Lui G, Treluyer JM, Fresneau B, Piperno-Neumann S, Gaspar N, Corradini N, Gentet JC, Marec Berard P, Laurence V, Schneider P, Entz-Werle N, Pacquement H, Millot F, Taque S, Freycon C, Lervat C, Le Deley MC, Mahier Ait Oukhatar C, Brugieres L, Le Teuff G, Bouazza N; Sarcoma Group of UNICANCER. A Pharmacokinetic and Pharmacogenetic Analysis of Osteosarcoma Patients Treated With High-Dose Methotrexate: Data From the OS2006/Sarcoma-09 Trial. J Clin Pharmacol. 2018 Dec;58(12):1541-1549. doi: 10.1002/jcph.1252. Epub 2018 May 23.

name: EA 7323; Université Paris Descartes Sorbonne Paris Cité; Paris France

name: Clinical Pharmacology Department; Cochin Hospital; Paris France

name: CIC-1419 Inserm; Cochin-Necker; Paris France

family: Lui

full_name: Gabrielle Lui

given: Gabrielle

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

name: Department of Children and Adolescents Oncology; Gustave Roussy; Villejuif France

name: Paris-Saclay University; CESP; INSERM; Villejuif France

family: Fresneau

full_name: Brice Fresneau

given: Brice

name: Medical Oncology Department; Institut Curie; Paris France

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Gaspar

full_name: Nathalie Gaspar

given: Nathalie

name: Pediatric Oncology Department; Mother-Children Hospital; Nantes France

family: Corradini

full_name: Nadège Corradini

given: Nadège

name: Pediatric Oncology Department; La Timone Children's Hospital; Marseille France

family: Gentet

full_name: Jean-Claude Gentet

given: Jean-Claude

name: Pediatric Oncology Department; Institute of Pediatric Hematology and Oncology-Léon Bérard Anticancer Center; Lyon France

family: Marec Berard

full_name: Perrine Marec Berard

given: Perrine

family: Laurence

full_name: Valérie Laurence

given: Valérie

name: Pediatric Hemato-Oncology Department; University Hospital; Rouen France

family: Schneider

full_name: Pascale Schneider

given: Pascale

name: Pediatric Oncology Department; CHU Hautepierre; Strasbourg France

family: Entz-Werle

full_name: Natacha Entz-Werle

given: Natacha

family: Pacquement

full_name: Hélène Pacquement

given: Hélène

family: Millot

full_name: Frédéric Millot

given: Frédéric

name: Department of Pediatric Hemato-Oncology; University Hospital; Rennes France

family: Taque

full_name: Sophie Taque

name: Pediatric Department; The Child and Family Hospital; University Hospital; Grenoble France

family: Freycon

full_name: Claire Freycon

given: Claire

name: Pediatric Oncology Unit; Centre Oscar Lambret; Lille France

family: Lervat

full_name: Cyril Lervat

given: Cyril

name: Biostatistics Unit; Gustave Roussy; Villejuif France

family: Le Deley

full_name: Marie Cécile Le Deley

given: Marie Cécile

family: Mahier Ait Oukhatar

ReferenceCitation: Tabone MD, Brugières L, Piperno-Neumann S, Selva MA, Marec-Bérard P, Pacquement H, Lervat C, Corradini N, Gentet JC, Couderc R, Chevance A, Mahier-Ait Oukhatar C, Entz-Werle N, Blay JY, Le Deley MC. Prognostic impact of blood and urinary angiogenic factor levels at diagnosis and during treatment in patients with osteosarcoma: a prospective study. BMC Cancer. 2017 Jun 15;17(1):419. doi: 10.1186/s12885-017-3409-z.

ReferenceCitation: Piperno-Neumann S, Le Deley MC, Rédini F, Pacquement H, Marec-Bérard P, Petit P, Brisse H, Lervat C, Gentet JC, Entz-Werlé N, Italiano A, Corradini N, Bompas E, Penel N, Tabone MD, Gomez-Brouchet A, Guinebretière JM, Mascard E, Gouin F, Chevance A, Bonnet N, Blay JY, Brugières L; Sarcoma Group of UNICANCER; French Society of Pediatric Oncology (SFCE); French Sarcoma Group (GSF-GETO). Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1070-1080. doi: 10.1016/S1470-2045(16)30096-1. Epub 2016 Jun 17.

ipd_sharing_description: IPD will not be shared at an individual level, they will be part of the study database including all enrolled patients.

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

title: OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma.


title: Experimental Study About Tongue Interactions With Teeth and Palate During Speech, Using Strain Gauge Transducer and Complete Denture. Comparison of Adaptation Phenomenon's Between Patients With New Complete Denture.

summary:
This research is about tongue's pressure during speech, using a complete denture which allows respecting tongue and speech physiology at the best.

A strain gauge transducer is placed inside this prosthodontics device. During speech, the pressure and the sounds are recording. The analysis of the twos signals should explain what pressure is needed for what sound. The comparison between old complete denture wearers and new one is realized to provide informations about tongue adaptation's phenomenon.

lead_sponsor: Hospices Civils de Lyon


lead_sponsor: University of Birmingham

location_country:
Switzerland
France
Ireland
Australia
New Zealand
United Kingdom

location_facility: Centre Hospitalier Regional Universitaire Brest - Hopital Morvan

location_facility: Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants

location_facility: Centre Hospitalier Universitaire De Rennes - Hopital Sud

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire De Limoges

location_facility: Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville

location_facility: Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin

location_facility: Centre Hospitalier Universitaire De NICE

location_facility: Centre Hospitalier Universitaire De Poitiers

location_facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: NHS Greater Glasgow and Clyde, The Royal Hospital for Children

location_facility: Luzerner Kantonspital - Kinderspital Luzern

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire De Caen

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire De Nancy

location_facility: Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Centre Hospitalier Universitaire Saint-etienne

location_facility: John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire De Rouen

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire Amiens - Picardie

location_facility: Centre Hospitalier Universitaire De Clermont-ferrand

location_facility: Southampton University Hospitals NHS Trust

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales

location_facility: Centre Hospitalier Universitaire Vaudois Chuv Lausanne

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire D'angers

location_facility: Centre Hospitalier Universitaire De Grenoble

location_facility: Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve

location_facility: NHS Lothian, Royal Hospital for Sick Children

location_facility: Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust

location_facility: Great Ormond Street Hospital For Children NHS Trust

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

title: International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

summary:
The main purpose of this study is :

To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction
To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin (anthracycline) & cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.)
To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy.
To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine & cytarabine (FLA) in standard risk patients.
To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.


title: Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis

summary:
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.

The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

lead_sponsor: Galderma R&D

location_country: Sweden Netherlands France Spain Germany

location_facility:
Investigative site
Investigational site


title: Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer

acronym: GON

summary:
Primary:

·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer

Secondary:

·To evaluate the toxicity of the combination

lead_sponsor: Sanofi


title: STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER

acronym: ADOKOT

summary:
- Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6 months.

- Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic, mixed or hypomanic symptoms.


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis

summary: Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study. Rheumatology (Oxford). 2012 Sep;51(9):1687-96. doi: 10.1093/rheumatology/kes125. Epub 2012 May 30.

family: Dougados

full_name: M. Dougados

given: M.

family: Braun

full_name: J. Braun

given: J.

family: Szanto

full_name: S. Szanto

given: S.

family: Combe

full_name: B. Combe

given: B.

family: Geher

full_name: P. Geher

given: P.

family: Leblanc

full_name: V. Leblanc

given: V.

family: Logeart

full_name: I. Logeart

given: I.

journal_name: Rheumatology

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: example of etanercept in advanced ankylosing spondylitis. Arthritis Care Res (Hoboken). 2012 Feb;64(2):290-4. doi: 10.1002/acr.20671.

full_name: Maxime Dougados

given: Maxime

full_name: Jurgen Braun

given: Jurgen

full_name: Sandor Szanto

given: Sandor

full_name: Bernard Combe

given: Bernard

full_name: Pal Geher

given: Pal

full_name: Véronique Leblanc

given: Véronique

full_name: Isabelle Logeart

given: Isabelle

title: Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: Example of etanercept in advanced ankylosing spondylitis

ReferenceCitation: Dougados M, Braun J, Szanto S, Combe B, Elbaz M, Geher P, Thabut G, Leblanc V, Logeart I. Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE). Ann Rheum Dis. 2011 May;70(5):799-804. doi: 10.1136/ard.2010.139261. Epub 2011 Feb 13. Erratum in: Ann Rheum Dis. 2011 Jul;70(7):1349.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer


title: International, Phase II Study of CyberKnife® for Hepatic Metastases From Colorectal Cancer

summary: This prospective, multicenter study is intended to establish the efficacy and toxicity of treating unresectable colorectal liver metastases with accurately administered radiation using the CyberKnife stereotactic radiosurgery system.

lead_sponsor: Accuray Incorporated

location_country:
Germany
United Kingdom
France

intervention_type: Radiation


title: Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome

acronym: MILESTONE

summary: The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. Patients will be randomized since the beginning of the study in two groups: standard HF dialysis and mid-dilution HDF.

ReferenceCitation: Stel VS, van de Luijtgaarden MW, Wanner C, Jager KJ; on behalf of the European Renal Registry Investigators. The 2008 ERA-EDTA Registry Annual Report-a précis. NDT Plus. 2011 Feb;4(1):1-13. Epub 2010 Nov 19.

ReferenceCitation: Grooteman MP, van den Dorpel MA, Bots ML, Penne EL, van der Weerd NC, Mazairac AH, den Hoedt CH, van der Tweel I, Lévesque R, Nubé MJ, ter Wee PM, Blankestijn PJ; CONTRAST Investigators. Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes. J Am Soc Nephrol. 2012 Jun;23(6):1087-96. doi: 10.1681/ASN.2011121140. Epub 2012 Apr 26.

ReferenceCitation: Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93.

ReferenceCitation: Locatelli F, Martin-Malo A, Hannedouche T, Loureiro A, Papadimitriou M, Wizemann V, Jacobson SH, Czekalski S, Ronco C, Vanholder R; Membrane Permeability Outcome (MPO) Study Group. Effect of membrane permeability on survival of hemodialysis patients. J Am Soc Nephrol. 2009 Mar;20(3):645-54. doi: 10.1681/ASN.2008060590. Epub 2008 Dec 17.

lead_sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_country: Italy Belgium France Spain


type: U.S. FDA Grant/Contract

title: A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride With Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

acronym: SeaSTAR

summary:
The purpose of this study is to determine if emixustat hydrochloride reduces the rate of progression of macular atrophy compared to placebo in subjects with Stargardt disease.

Funding Source -- FDA OOPD

ipd_sharing: Undecided

lead_sponsor: Kubota Vision Inc.

location_country:
Italy
Brazil
South Africa
Netherlands
Germany
France
Spain
Denmark
United States
United Kingdom
Canada

location_facility: University of Michigan Kellogg Eye Center

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Retina-Vitreous Associates Medical Group

location_facility: AOU Università della Campania Luigi Vanvitelli

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: University of Utah John Moran Eye Center

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Oxford Eye Hospital,Oxford University Hospitals NHS Foundation Trust

location_facility: Universitätsklinikum Tübingen, Department für Augenheilkunde

location_facility: The Wilmer Eye Institute Johns Hopkins University

location_facility: UOC Oculistica Asst Fatebene Pratelli Sacco Universita delgi Studi di Milano

location_facility: Università Cattolica del Sacro Cuore - Fondazione Policlinico Gemelli

location_facility: Medical College of Wisconsin-Eye Institute


title: Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

summary: Management of participants with low-level persistent viremia

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital de l'Hôtel Dieu
Hôpital Charles Nicoll
Hôpital Saint André
Hôpital de Bicêtre
Hôpital Necker
Hôpital Européen Georges Pompidou
Hôpital Purpan
Hôpital Tenon
Hôpital Saint Louis
Hôpital Bichat
Hôpital Pontchaillou
Hôpital pitié Salpetrière
Hôpital Henry Mondor
Hôpital de la côte de Nacre
Hôpital Cochin
Hôpital Avicenne
Hôpital Hôtel Dieu
Hôpital Jean Verdier
Hôpital Pellegrin
Hôpital Lariboisière

intervention_type: Other


ReferenceCitation: Defachelles AS, Bogart E, Casanova M, Merks JHM, Bisogno G, Calareso G, Gallego Melcon S, Gatz SA, Le Deley MC, McHugh K, Probst A, Rocourt N, van Rijn RR, Wheatley K, Minard-Colin V, Chisholm JC. Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft Tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial. J Clin Oncol. 2021 Sep 20;39(27):2979-2990. doi: 10.1200/JCO.21.00124. Epub 2021 Aug 3.

name: Department of Pediatric and Adolescent Oncology, INSERM U1015, Gustave Roussy, Université Paris-Saclay, Villejuif, France

family: Defachelles

full_name: Anne-Sophie Defachelles

given: Anne-Sophie

family: Bogart

full_name: Emilie Bogart

given: Emilie

name: Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

family: Casanova

full_name: Michela Casanova

given: Michela

name: Princess Maxima Center for Pediatric Oncology, Utrecht, the Netherlands

family: Merks

full_name: Johannes H. M. Merks

given: Johannes H. M.

name: Department of Women and Children Health, University Hospital of Padova, Padova, Italy

family: Bisogno

full_name: Gianni Bisogno

given: Gianni

family: Calareso

full_name: Giuseppina Calareso

given: Giuseppina

name: University Hospital Vall d’Hebron, Barcelona, Spain

family: Gallego Melcon

full_name: Soledad Gallego Melcon

given: Soledad

name: Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, United Kingdom

family: Gatz

full_name: Susanne Andrea Gatz

given: Susanne Andrea

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

name: Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom

family: McHugh

full_name: Kieran McHugh

given: Kieran

family: Probst

full_name: Alicia Probst

given: Alicia

family: Rocourt

full_name: Nathalie Rocourt

given: Nathalie

name: Amsterdam University Medical Centers, Amsterdam, Netherlands

family: van Rijn

full_name: Rick R. van Rijn

given: Rick R.

family: Wheatley

full_name: Keith Wheatley

given: Keith

family: Minard-Colin

full_name: Véronique Minard-Colin

name: Children and Young People's Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, Sutton, United Kingdom

family: Chisholm

full_name: Julia C. Chisholm

given: Julia C.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial

location_facility: Hôpital des Enfants, Groupe Hospitalier Pellegrin

title: International Randomized Phase II Trial of the Combination of Vincristine and Irinotecan With or Without Temozolomide (VI or VIT) in Children and Adults With Refractory or Relapsed Rhabdomyosarcoma

summary: This is an international open-label, randomized, multicenter phase II study of VIT and VI for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will evaluate the safety and efficacy of these combinations in patients with recurrent or refractory rhabdomyosarcoma.


lead_sponsor: Tiziana Life Sciences, PLC

location_country:
Italy
United States
France

location_facility: NIH, Center for Cancer Research, Medical Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

location_facility: TGen Clinical Research Services at Scottsdale Healthcare

title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy

summary: The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.


title: A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir,Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve Subjects With CD4counts Below 200 µL.

acronym: DATA

summary: A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.

ReferenceCitation: Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabié A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10.

family: Slama

full_name: Laurence Slama

given: Laurence

family: Landman

full_name: Roland Landman

given: Roland

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

family: Benalycherif

full_name: Aida Benalycherif

given: Aida

family: Samri

full_name: Assia Samri

given: Assia

family: Joly

full_name: Véronique Joly

given: Véronique

family: Pialoux

full_name: Gilles Pialoux

given: Gilles

family: Valin

full_name: Nadia Valin

given: Nadia

family: Cabié

full_name: André Cabié

given: André

family: Duvivier

full_name: Claudine Duvivier

given: Claudine

family: Lambert-Niclot

full_name: Sidonie Lambert-Niclot

given: Sidonie

family: Marcelin

full_name: Anne-Geneviève Marcelin

given: Anne-Geneviève

family: Peytavin

full_name: Gilles Peytavin

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hopital Necker
Hopital Saint-Andre
Hopital Europeen Georges Pompidou
Hopital L'Archet
Hopital Zobda Quitman
Hopital Dupuytren
Hopital Rene Dubos
Hopital Avicenne
Chu Cote de Nacre
Hopital Gustave Dron
C.H.R.A
Centre Hospitalier de Melun
Hopital Le Bocage
Hopital Civil
Hopital Bretonneau
Hopital Louis Mourier
Hopital Saint-Jacques
Hopital Bichat
Hopital Jean Verdier
Hopital Raymond Poincare
Hopital Lariboisiere
Hopital Sainte-Marguerite
C.H.D de Vendee
Hopital Saint Antoine
Hopital Cochin
Hopital Pitie-Salpetriere
Hopital Saint-Jean Roussillon
Centre Hospitalier D'Argenteuil
Hopital Tenon


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: TEMO-CARB

location_facility: APHP - Georges Pompidou European Hospital

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

title: Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections, a Non-inferiority Study

summary: TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.