title: Comparison of C-reactive Protein and Procalcitonin to Detect Infectious Complications After Elective Colorectal Surgery

acronym: IMACORS

summary:
The clinical symptoms of septic complications (SC) (responsible for the majority of morbidity in colorectal surgery) become apparent only 5-7 days after the operation, whereas the efficacy of treatment depends on early diagnosis. By detecting such complications early it could be possible to reduce their severity, the length of hospitalisation, repeat colostomy and the number of readmissions. Our team has shown that C-reactive protein (CRP) > 125 mg/L at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin (PCT) is a marker of sepsis currently used in intensive care, but its use in the follow-up of elective surgery, particularly colorectal surgery, has not been fully evaluated.

The aim of this study is to compare the ability of CRP and PCT to detect SC as early as postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC) after elective colorectal surgery.

Adult patients about to undergo elective colorectal surgery with anastomosis will be included once they have given their written informed consent. Levels of CRP and PCT will be measured the day before the surgery, then at D1, D2, D3 and D4. The clinical data (temperature, recovery of bowel movement, pain, pain on palpation) will be recorded daily. Imaging examinations will be performed at the discretion of the surgeon; the only obligation will be to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 > 125 mg/L with no other clinical anomalies. The discriminating ability (measured by the area under the ROC curve) of CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be necessary to show the superiority of PCT over CRP in clinical terms and with regard to the cost.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon
CGFL
CHU Besançon

intervention_type: Biological


ReferenceType: derived

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5:CD011220. doi: 10.1002/14651858.CD011220.pub2.

name: Medical Oncology Department; St John of God Midland; Perth Australia

name: Medical Oncology Department; Sir Charles Gairdner Hospital; Perth Australia

family: Hoon

full_name: Siao-Nge Hoon

given: Siao-Nge

sequence: additional

name: Medical Oncology Department; Peter MacCallum Cancer Centre; Melbourne Australia

family: Lau

full_name: Peter K H Lau

given: Peter K H

name: Murdoch Community Hospice; St John of God Hospital Murdoch; Perth Australia

name: Palliative Care Department; Royal Perth Hospital; Perth Australia

family: White

full_name: Alison M White

given: Alison M

name: Institute for Health Research; University of Notre Dame Australia; Fremantle Australia

name: School of Population and Global Health; The University of Western Australia; Perth Australia

name: Division of Surgery and Interventional Science; University College London; London UK

family: Bulsara

full_name: Max K Bulsara

given: Max K

name: Medical Oncology Department; University Hospital Geelong; Geelong Australia

family: Banks

full_name: Patricia D Banks

given: Patricia D

name: School of Medicine; University of Western Australia; Perth Australia

name: Medical Oncology Department; Fiona Stanley Hospital; Perth Australia

family: Redfern

full_name: Andrew D Redfern

given: Andrew D

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Miyoshi Y, Yoshimura Y, Saito K, Muramoto K, Sugawara M, Alexis K, Nomoto K, Nakamura S, Saeki T, Watanabe J, Perez-Garcia JM, Cortes J. High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin-but not with treatment of physician's choice-in the EMBRACE study. Breast Cancer. 2020 Jul;27(4):706-715. doi: 10.1007/s12282-020-01067-2. Epub 2020 Mar 5.

family: Miyoshi

full_name: Yasuo Miyoshi

given: Yasuo

sequence: first

family: Yoshimura

full_name: Yuta Yoshimura

given: Yuta

family: Saito

full_name: Kenichi Saito

given: Kenichi

family: Muramoto

full_name: Kenzo Muramoto

given: Kenzo

family: Sugawara

full_name: Michiko Sugawara

given: Michiko

family: Alexis

full_name: Karenza Alexis

given: Karenza

family: Nomoto

full_name: Kenichi Nomoto

family: Nakamura

full_name: Seigo Nakamura

given: Seigo

family: Saeki

full_name: Toshiaki Saeki

given: Toshiaki

family: Watanabe

full_name: Junichiro Watanabe

given: Junichiro

family: Perez-Garcia

full_name: Jose Manuel Perez-Garcia

given: Jose Manuel

family: Cortes

full_name: Javier Cortes

given: Javier

journal_name: Breast Cancer

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

title: High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin—but not with treatment of physician’s choice—in the EMBRACE study

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

name: All authors: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Twelves C, Cortes J, Kaufman PA, Yelle L, Awada A, Binder TA, Olivo M, Song J, O'Shaughnessy JA, Jove M, Perez EA. "New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy. Breast Cancer Res. 2015 Dec 9;17(1):150. doi: 10.1186/s13058-015-0657-1.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

title: “New” metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy

ReferenceCitation: Muss H, Cortes J, Vahdat LT, Cardoso F, Twelves C, Wanders J, Dutcus CE, Yang J, Seegobin S, O'Shaughnessy J. Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer. Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

name: University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, USA;

name: Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain;

name: Weill Cornell Medical College, New York, New York, USA;

name: Jules Bordet Institute, Brussels, Belgium;

name: University of Leeds and St James's Institute of Oncology, Leeds, UK;

name: Eisai Inc., Woodcliff Lake, New Jersey, USA;

name: NJS Associates Company, Somerset, New Jersey USA;

name: Baylor‐Charles A. Sammons Cancer Center, Texas Oncology, and US Oncology, Dallas, Texas, USA

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

title: Eribulin Monotherapy in Patients Aged 70 Years and Older With Metastatic Breast Cancer

ReferenceCitation: Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Diéras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

ReferenceCitation: Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA. Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clin Breast Cancer. 2010 Apr;10(2):160-3. doi: 10.3816/CBC.2010.n.023.

title: Phase III Trials of Eribulin Mesylate (E7389) in Extensively Pretreated Patients With Locally Recurrent or Metastatic Breast Cancer

location_country:
Italy
Austria
Brazil
South Africa
Switzerland
Spain
Croatia
Czechia
France
Poland
Hungary
Argentina
Australia
Belgium
Russian Federation
United States
Canada

location_facility: Peachtree Hematology/Oncology Consultants, PC

location_facility: Centrum Onkologii Instytut M. Sklodowskiej Curie w Warszawie Oddzial Gilwice

location_facility: Markusovszky Teaching Hospital, Dept. of Oncoradiology, Sec. Med. Oncology

location_facility: State Institution of Healthcare Stavropol Region clinical Oncology dispensary

location_facility: Hospital Universitario de Girona Dr. Josep Trueta

location_facility: US Oncology St. Vincent's Hospital - Bruno Cancer Center

location_facility: North Shore Hematology/Oncology Associates

location_facility: CEPHO-Centro de Estudos e Pesquisa de Hematologia e oncologia

location_facility: McGill University Health Centre, Department of Oncology, Gerald Bronfman Center

location_facility: GUZ YO Regional Clinical Oncology Hospital

location_facility: Royal Perth Hospital, Department of Medical Oncology

location_facility: NN Petrov Research Institute of Oncology

location_facility: Centrum Onkologii Instytut M Sklodowskiej Curie, Oddzial w Krakowie

location_facility: Szpital Kiniczny Przemienienia Panskiego Uniwersyteu Medycznego im Karola Marcinkowskiego w Poznaniu

location_facility: Centrum Onkologii Instytut im M. Sklodowskiej Curie w Warszawie

location_facility: AZ Groeninge, Campus Maria's Voorzienigheid

location_facility: Clinica Universitaria Privada Reina Fabiola

location_facility: Salzburger Landeskliniken Universitatsklinik fur Innere medizin III

location_facility: Szpital Morski im PCK w Gdyni Gdynskie Centrum Onkologii

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Eastern Cape Oncology Centre, GVI, St Georges Hospital

location_facility: Centre Hospitalier Notre-Dame - Reine Fabiola

location_facility: Centro Regional Integrado de Oncologia-CRIO

location_facility: Hosptial Interzonal General de Mar del Plata

location_facility: Semmelweis Medical University, III. Dep. of Internal Med.

location_facility: Centro de Pesquisas e Estudios do Centro Goiano

location_facility: The Ottawa Hospital Regional Cancer Center

location_facility: Debrecen Medical University, Department of Oncology

location_facility: Instituto de Oncologia y Especialidades Medicas

location_facility: Krasnodar Territory Clinical Oncology Center

location_facility: Instituto Nacional do Cancer-Unidade III (INCA III)

location_facility: Akademickie Centrum Kliniczne Szpital Akademii Medycznej w

title: The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

summary: The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.


type: Other Identifier

type: EudraCT Number

title: The Effect of Tasisulam on CYP3A-mediated Metabolism of Midazolam: A Pharmacokinetic Interaction Study in Cancer Patients With Advanced and/or Metastatic Tumors or Lymphoma

summary:
The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using midazolam as a sensitive and specific probe substrate of CYP3A.

The study will also assess the safety and tolerability of tasisulam and midazolam given in combination and document any antitumor activity with tasisulam.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: Eli Lilly and Company

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Auto-immunity and Prognosis of Pulmonary Arterial Hypertension

acronym: Auto-HTAP

summary:
The investigators have recently evidenced the presence of antibodies to endothelial cells and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have identified several target antigens of anti-fibroblasts antibodies.

The objective of this study is to further investigate for the presence of antibodies to endothelial cells and fibroblasts in patients and characterize the antigen specificity of autoantibodies in patients with different types of non idiopathic and non SSc-associated PAH, such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital heart diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's syndrome

study_start_date_type: Actual

status: Completed

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Internal Medicine Department, Cochin Hospital

location_facility: Internal Medicine Department, Claude Huriez Hospital

location_facility: Pneumology Department, Antoine Béclère Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Phase II" Proof of Concept " Trial Evaluating Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab in Combination With Chemotherapy in Breast Cancer

acronym: AVASTEM

summary: The purpose of this study is to evaluate anti-cancer stem cell (CSC) activity (measured by the amount of Aldehyde dehydrogenase 1/ALDH1+ cells before and after treatment) of pre-operative bevacizumab in combination with conventional chemotherapy in breast cancer receiving neo-adjuvant treatment, compared to a control arm receiving chemotherapy alone.

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Jean-Yves PIERGA
Hervé CURE
Jean-Marc EXTRA, MD


title: A Pilot Study to Evaluate the Applicability of the Crohn's Disease Endoscopy Index of Severity to Data Obtained by the Colonic Capsule Endoscopy in Ileocolonic Crohn's Disease

acronym: CAPSCOL

summary:
The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and the surface of lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's Disease Endoscopic Index of Severity is the main score used in controlled trials to assess the endoscopic severity of lesions in Crohn's Disease.

The investigators aim to conduct a prospective pilot study primarily to evaluate the applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule endoscopy lead to comparable overall severity evaluations.

Secondary objectives are to assess reproducibility of the reading of data obtained by CCE and to compare these data with those obtained by conventional ileocolonoscopy. If overall severity evaluations derived from the two examinations are not comparable, the secondary objectives will be used in an attempt to understand the reasons of this discrepancy.

ReferenceType: result

ReferenceCitation: Casellas F, Vivancos JL, Sampedro M, Malagelada JR. Relevance of the phenotypic characteristics of Crohn's disease in patient perception of health-related quality of life. Am J Gastroenterol. 2005 Dec;100(12):2737-42.

ReferenceCitation: Itzkowitz SH, Harpaz N. Diagnosis and management of dysplasia in patients with inflammatory bowel diseases. Gastroenterology. 2004 May;126(6):1634-48. Review.

ReferenceCitation: Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464.

ReferenceCitation: Rutter M, Saunders B, Wilkinson K, Rumbles S, Schofield G, Kamm M, Williams C, Price A, Talbot I, Forbes A. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology. 2004 Feb;126(2):451-9.

ReferenceCitation: Triester SL, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. Am J Gastroenterol. 2005 Nov;100(11):2407-18.

ReferenceCitation: Kahn JL, Sick H, Laude M, Koritke JG. [Vascularization of the adipose body of the cheek]. Arch Anat Histol Embryol. 1990;73:3-20. French.

ReferenceCitation: Eliakim R, Fireman Z, Gralnek IM, Yassin K, Waterman M, Kopelman Y, Lachter J, Koslowsky B, Adler SN. Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study. Endoscopy. 2006 Oct;38(10):963-70.

ReferenceCitation: Schoofs N, Devière J, Van Gossum A. PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study. Endoscopy. 2006 Oct;38(10):971-7.

ReferenceCitation: Mary JY, Modigliani R. Development and validation of an endoscopic index of the severity for Crohn's disease: a prospective multicentre study. Groupe d'Etudes Thérapeutiques des Affections Inflammatoires du Tube Digestif (GETAID). Gut. 1989 Jul;30(7):983-9.

ReferenceCitation: Modigliani R, Mary JY, Simon JF, Cortot A, Soule JC, Gendre JP, Rene E. Clinical, biological, and endoscopic picture of attacks of Crohn's disease. Evolution on prednisolone. Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives. Gastroenterology. 1990 Apr;98(4):811-8.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chru Lille
Chu Nantes
Hopital Beaujon

intervention_type: Procedure


ReferenceCitation: Esteban-Cantos A, Rodríguez-Centeno J, Barruz P, Alejos B, Saiz-Medrano G, Nevado J, Martin A, Gayá F, De Miguel R, Bernardino JI, Montejano R, Mena-Garay B, Cadiñanos J, Florence E, Mulcahy F, Banhegyi D, Antinori A, Pozniak A, Wallet C, Raffi F, Rodés B, Arribas JR; NEAT001/ANRS143 Study Group. Epigenetic age acceleration changes 2 years after antiretroviral therapy initiation in adults with HIV: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2021 Apr;8(4):e197-e205. doi: 10.1016/S2352-3018(21)00006-0. Erratum in: Lancet HIV. 2021 Jul 6;:.

family: Esteban-Cantos

full_name: Andrés Esteban-Cantos

given: Andrés

family: Rodríguez-Centeno

full_name: Javier Rodríguez-Centeno

family: Barruz

full_name: Pilar Barruz

given: Pilar

family: Alejos

full_name: Belén Alejos

given: Belén

family: Saiz-Medrano

full_name: Gabriel Saiz-Medrano

given: Gabriel

family: Nevado

full_name: Julián Nevado

given: Julián

family: Martin

full_name: Artur Martin

given: Artur

family: Gayá

full_name: Francisco Gayá

given: Francisco

family: De Miguel

full_name: Rosa De Miguel

given: Rosa

family: Bernardino

full_name: Jose I Bernardino

given: Jose I

family: Montejano

full_name: Rocío Montejano

given: Rocío

family: Mena-Garay

full_name: Beatriz Mena-Garay

given: Beatriz

family: Cadiñanos

full_name: Julen Cadiñanos

given: Julen

family: Florence

full_name: Eric Florence

given: Eric

family: Mulcahy

full_name: Fiona Mulcahy

given: Fiona

family: Banhegyi

full_name: Denes Banhegyi

given: Denes

family: Antinori

full_name: Andrea Antinori

given: Andrea

family: Pozniak

full_name: Anton Pozniak

given: Anton

family: Wallet

full_name: Cédrick Wallet

given: Cédrick

family: Raffi

full_name: François Raffi

given: François

family: Rodés

full_name: Berta Rodés

given: Berta

family: Arribas

full_name: Jose R Arribas

given: Jose R

journal_name: The Lancet HIV

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Ammassari A, Stöhr W, Antinori A, Molina JM, Schwimmer C, Domingo P, Thalme A, Di Pietro M, Wallet C, Pozniak A, Richert L, Raffi F; NEAT001/ANRS143 Trial Study Group. Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial. J Acquir Immune Defic Syndr. 2018 Dec 1;79(4):481-490. doi: 10.1097/QAI.0000000000001834.

family: Ammassari

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

repository_institution: University College London - UCL Discovery

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Bernardino JI, Mocroft A, Mallon PW, Wallet C, Gerstoft J, Russell C, Reiss P, Katlama C, De Wit S, Richert L, Babiker A, Buño A, Castagna A, Girard PM, Chene G, Raffi F, Arribas JR; NEAT001/ANRS143 Study Group. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015 Nov;2(11):e464-73. doi: 10.1016/S2352-3018(15)00181-2. Epub 2015 Sep 30.

title: Bone mineral density and inflammatory and bone biomarkers after darunavir–ritonavir combined with either raltegravir or tenofovir–emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial

ReferenceCitation: Raffi F, Babiker AG, Richert L, Molina JM, George EC, Antinori A, Arribas JR, Grarup J, Hudson F, Schwimmer C, Saillard J, Wallet C, Jansson PO, Allavena C, Van Leeuwen R, Delfraissy JF, Vella S, Chêne G, Pozniak A; NEAT001/ANRS143 Study Group. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014 Nov 29;384(9958):1942-51. doi: 10.1016/S0140-6736(14)61170-3. Epub 2014 Aug 4.

title: Ritonavir-boosted darunavir combined with raltegravir or tenofovir–emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial

location_country:
Italy
Austria
Sweden
Netherlands
Spain
France
Poland
Greece
Hungary
Belgium
Ireland
Portugal
Denmark
Germany
United Kingdom

location_facility: Hospital of Infectious Diseases of Warsaw

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Istituto Naziona e per le Malattie "Lazzaro Spallanzani"

location_facility: Hospital General Universitario de Alicante

location_facility: Klinikum der Johann Wolfgang Goethe Universität

title: An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001)

summary:
The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.

In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.


ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10.

family: Dossier

full_name: Claire Dossier

given: Claire

family: Hogan

full_name: Julien Hogan

given: Julien

bso_classification: Social sciences

journal_name: Pediatric Nephrology

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Response to Majeranowski

status: Recruiting

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
United States
Peru
South Africa
Mexico
Germany
France
Poland
Israel
Argentina
Russian Federation
Spain
Canada
United Kingdom
Colombia

acronym: REGENCY

location_facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

location_facility: Servicio de Inmuno Reumatologia; Hospital Nacional Arzobispo Loayza

location_facility: Winelands Medical Research; Medical Research

location_facility: Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex

location_facility: Hospital de Basurto; Servicio de Reumatologia

location_facility: Universitätskrankenhaus Tübingen; Rheumatol. / Haematol. / Internist. Onkologie

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi UM; Katedra i Klinika Reumatologii

location_facility: ASST Monza - Ospedale San Gerardo; Clinica Nefrologica

location_facility: Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia

location_facility: Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB

location_facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

location_facility: Hospital Italiano de Buenos Aires; Rheumatology department

location_facility: Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov; Rheumatology Department

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología

location_facility: Ospedale ARNAS - P.O."Civico e Benfratelli; UOC Nefrologia e Dialisi

location_facility: Limited Liability Company "Centre of Medical Common Practice"

location_facility: Hospital Nacional Cayetano Heredia; Rheumatology

location_facility: CHU de Martinique- Hôpital P. Zobda-Quitman; Service de Rhumatlogie- Médecine interne 5D

location_facility: The Ohio State University Wexner Medical Center

location_facility: SIH Kemerovo Regional Clinical Hospital; Neurology department

location_facility: SPZOZ Centralny Szpital Klin; UM w Lodzi

location_facility: Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica

location_facility: NYU Langone Medical Center; Seligman Center for Advanced Therapeutics

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

location_facility: Hospital Universitario 12 de Octubre; Servicio de Reumatologia

location_facility: Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Medicina Interna

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: SPSK Nr 7 SUM w Katowicach Gornoslaskie CM im. prof. Leszka Gieca

location_facility: University of Alabama at Birmingham Medical Center

location_facility: Veterans Affairs Medical Center; Gastronenterology/Hepatology

location_facility: SPSK nr 2 Pomorskiej AM w Szczecinie; Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Sociedad de Cirugia de Bogota Hospital San Jose

location_facility: Städtisches Klinik Dresden-Friedrichstadt; I. Medizinische Klinik

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: "Kazan (Privolzhsky) Federal University"; Academic Hospital

location_facility: Hopital Bichat Claude Bernard; Nephrologie

location_facility: Medyczne Centrum Hetmanska; Rheumatology

location_facility: Hopital Universitaire; Nephrologie Clinique Medicale B

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Hospital General De Mexico; Rheumatology

location_facility: Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi

location_facility: Washington University School of Medicine

location_facility: SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia

location_facility: Groote Schuur Hospital and University of Cape Town; E13 Renal Unit & J46 Dept of Medicine

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Republican Hospital Named After V.A. Baranov

location_facility: SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C.

location_facility: Hospital Universitario Araba; Servicio de Reumatologia

location_facility: CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease

location_facility: Hospital Universitario Reina Sofia; Servicio de Nefrologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Instituto del Cerebro y la Columna Vertebral SAC

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii

location_facility: HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

location_facility: Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique

location_facility: Universitaetsmedizin Johannes Gutenberg; Rheumatologie

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Panaroma Medical Center; Clinical Trials Department

location_facility: Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin

location_facility: University of Miami Miller School of Medicine

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Reumatologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia

location_facility: Uniwersytecki Szpital Kliniczny Nr 2 Im. Wam; Centralny Szpital Weteranow

location_facility: Ospedale San Giovanni Bosco; Unita Operativa Nefrologia Dialisi

location_facility: SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Hospital Universitario; Dr. Jose Eleuterio Gonzalez

location_facility: Royal Free Hospital; Centre for Nephrology

study_completion_date_type: Anticipated

source: euctr

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

status_simplified: Ongoing


title: Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

summary: The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.

lead_sponsor: Nantes University Hospital

location_facility:
CHU de Bordeaux
Institut Paoli Calmettes
CHU de Nantes


title: Interest of the Combination of the DaTSCAN Scintigraphy and MRI Scan in the Differential Diagnosis of Lewy Body Dementia From Alzheimer Disease in Patients With Hallucinations

acronym: DatScan

summary: The aim of this study is to improve the diagnostic of Lewy body dementia by combining the scintigraphy (SPECT) usig a spécific transporter and magnetic resonance imaging (MRI).

lead_sponsor: University Hospital, Limoges

location_facility: Pôle de psychiatrie du sujet âgé - CH Esquirol

location_facility: Département de Gérontologie - Chu Limoges


title: Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers

acronym: MAUV

summary:
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.

To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.

To evaluate rate of amputations and recurrence at one year after complete cicatrisation

location_facility: Service de Médecine Interne et Pathologie Vasculaire

location_facility: Service de Chirurgie Thoracique, cardiovasculaire et angiologie

location_facility: Service de Chirurgie Vasculaire et Viscérale


title: Effect of Prematurity on Renal Function in 5 Years Old Children Comparison of Former Premature Children Treated by Ibuprofen in the Neonatal Period to Controls

acronym: SUIVIREIN

summary:
Purpose of the study:

To evaluate the effect of prematurity on renal function in 5 years old children
To compare former premature children treated by ibuprofen in the neonatal period to controls

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Vieux R, Hascoët JM, Franck P, Guillemin F. Increased albuminuria in 4-year-old preterm-born children with normal height. J Pediatr. 2012 Jun;160(6):923-8.e1. doi: 10.1016/j.jpeds.2011.12.005. Epub 2012 Jan 18.

family: Vieux

full_name: Rachel Vieux

given: Rachel

family: Hascoët

full_name: Jean-Michel Hascoët

given: Jean-Michel

family: Franck

full_name: Patricia Franck

given: Patricia

family: Guillemin

full_name: F. Guillemin

given: F.

journal_name: The Journal of Pediatrics

title: Increased Albuminuria in 4-Year-Old Preterm-Born Children with Normal Height

lead_sponsor: Jean Michel Hascoet

location_facility:
CHU
Maternite Regionale Universitaire
AP-HM (Néonatologie)


title: Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study

acronym: ARABUL

summary:
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an initial large hospitalization during the acute phase and rehospitalization during relapse. The usefulness of immunosuppressive drugs have suggested by uncontrolled study.

In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or resistance risks.

This study could prove the efficacity of leflunomide, associated with short time topical corticosteroids.

status: Unknown status

location_facility:
Limoges University Hospital
Bordeaux University Hospital
Toulouse University Hospital


title: A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer.

summary: This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine (25mg/m²/week continuously, representing the schedule that has been approved). Patients eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at 200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of study medication. Blood samples will be collected at specified time points to assess pharmacokinetic endpoints.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius REGAUD
Institut Curie
Centre René GAUDUCHEAU


title: Af Ablation In Brady-Tachy Syndrome

acronym: Alternative

summary:
The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden.

The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.

lead_sponsor: Abbott Medical Devices

location_facility:
Clinique Pasteur
Hôpital St joseph
CHU


title: Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

acronym: PHYTOPLAQUES

summary: The objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption.

lead_sponsor: French Cardiology Society

location_facility: Hôpital cardio-vasculaire et pneumologique Louis Pradel

location_facility: Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Endocrinology and Metabolism Department

intervention_type: Dietary Supplement


title: Non Invasive Diagnostic Methods for Fibrosis in Alcoholic Liver Disease : FIBROSCAN Validation and Comparison of Fibrotest - FIBROSCAN Association With FIBROSCAN Alone

acronym: FIBROMAF

summary:
Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) are already used in current practice. The aim of this study is to validate the diagnostic value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this diagnostic strategy.

Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve of the scores will be compared using Z test.

location_facility:
Hôpital Claude Huriez
AP-HP Hôpital Antoine Beclere
AP-HP Hôpital Cochin


title: Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler

acronym: AngioPred

summary: Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de Gynécologie Obstétrique - CHU Saint-Etienne


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients

summary: This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.

lead_sponsor: Novartis


title: Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study

acronym: ICAR

summary: For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.

lead_sponsor: Rennes University Hospital

location_facility: Service de Chirugie Viscérale - Hôpital de Pontchaillou

location_facility: Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes

location_facility: Département d'Oncologie Médicale - CRLCC Eugène Marquis


title: Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

summary: Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients

lead_sponsor: Nestlé

location_facility:
Hopital Emile Roux
Hopital Charles RICHET
Hôpital Georges Clemenceau


title: An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia

summary: The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia

lead_sponsor: Solvay Pharmaceuticals

location_facility:
Site 1
Site 3
Site 2


title: Prognostic Value of Cardiac and Renal Markers in the Acute Phase of Ischemic Stroke or Transient Ischemic Attack :Albuminuria-Brain Natriuretic Peptide-Cystatine C in Stroke

acronym: ABC-AVC

summary: Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome, recurrence of cardiovascular events or vascular death.Until now, no reliable predictive biological marker could be identified in the acute phase of stroke.We hypothese that, in the acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide, BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular events or vascular death. We want to assess which one of these markers has the best prognosis value , in a prospective study of 300 stroke patients followed during 3 years.

lead_sponsor: University Hospital, Tours

location_facility: Service de neurologie / CHU Pontchaillou


title: IATROREF III: a Multifaceted Program for Improving Quality of Care in Critically Ill Patients

summary:
Medical errors that affect patient safety have generated huge concern since the publication of "To Err Is Human" 6 years ago [1]. Given the complexity of management in the intensive care unit (ICU) and the nature of human activities, critically ill patients are exposed to adverse events (AEs) induced by medical errors. A large number of studies have focused on AEs and medical errors in ICUs [2-6], one of their main goals being to identify strategies for preventing AEs and thereby improving patient outcomes. Choosing the best AE to serve as an indicator for the risk of medical error is challenging. In 2005, our group conducted a systematic literature review and presented the results to 30 national experts with clinical backgrounds in internal, emergency, and intensive care medicine. Using the Delphi technique, these experts selected 14 AEs that had the following characteristics: high frequency, easy and reproducible definition, association with morbidity and mortality, and ease of reporting without fear of punishment (Iatroref I study) (ref abstract). These AEs were used in a French multicenter study (75 ICUs) for a weeklong incidence evaluation (Iatroref II study) (ref abstract). Preliminary evaluation of the results allowed us to choose the following AEs for the current Iatroref III study: error in insulin administration, error in anticoagulant administration, error in anticoagulant prescription, unplanned extubation, and unplanned removal of central venous catheter. Evidence suggests that guidelines alone without reinforcing strategies may be insufficient to change provider behavior and that the most effective interventions may be multifaceted rather than single-component strategies ([7]). This study will test a composite intervention program. The objectives of the study are to determine whether the introduction of a composite intervention program decreases the predefined AEs.

Study hypothesis: The intervention program will decrease the incidence of the predefined AEs.

ReferenceCitation: Garrouste-Orgeas M, Soufir L, Tabah A, Schwebel C, Vesin A, Adrie C, Thuong M, Timsit JF; Outcomerea Study Group. A multifaceted program for improving quality of care in intensive care units: IATROREF study. Crit Care Med. 2012 Feb;40(2):468-76. doi: 10.1097/CCM.0b013e318232d94d.

family: Garrouste-Orgeas

full_name: Maite Garrouste-Orgeas

given: Maite

family: Soufir

full_name: Lilia Soufir

given: Lilia

family: Tabah

full_name: Alexis Tabah

given: Alexis

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Vesin

full_name: Aurelien Vesin

given: Aurelien

family: Adrie

full_name: Christophe Adrie

given: Christophe

family: Thuong

full_name: Marie Thuong

given: Marie

family: Timsit

full_name: Jean Francois Timsit

given: Jean Francois

journal_name: Critical Care Medicine

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Medical and surgical Intensive Care unit


title: Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases

summary:
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the patient's response to treatment.

PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in evaluating response to treatment in patients undergoing radiofrequency ablation for lung metastases.

ReferenceCitation: Bonichon F, Palussière J, Godbert Y, Pulido M, Descat E, Devillers A, Meunier C, Leboulleux S, de Baère T, Galy-Lacour C, Lagoarde-Segot L, Cazeau AL. Diagnostic accuracy of 18F-FDG PET/CT for assessing response to radiofrequency ablation treatment in lung metastases: a multicentre prospective study. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1817-27. doi: 10.1007/s00259-013-2521-9. Epub 2013 Sep 17.

family: Bonichon

full_name: Françoise Bonichon

given: Françoise

family: Palussière

full_name: Jean Palussière

given: Jean

family: Godbert

full_name: Yann Godbert

given: Yann

family: Pulido

full_name: Marina Pulido

given: Marina

family: Descat

full_name: Edouard Descat

given: Edouard

family: Devillers

full_name: Anne Devillers

given: Anne

family: Meunier

full_name: Catherine Meunier

given: Catherine

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

family: de Baère

full_name: Thierry de Baère

given: Thierry

family: Galy-Lacour

full_name: Claire Galy-Lacour

family: Lagoarde-Segot

full_name: Laurent Lagoarde-Segot

given: Laurent

family: Cazeau

full_name: Anne-Laure Cazeau

given: Anne-Laure

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Institut Bergonié

location_facility:
Hopital Haut Leveque
Centre Hospitalier de la Cote Basque
Institut Bergonie


title: Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

acronym: HaWPYC

summary: HaWPYC is an international Post-Market Clinical Follow-up (PMCF) to collect post-market safety and performance data on commercially available Wright Medical Pyrocarbon (PyC) hand and wrist implants. Data may be used for Post-Market Surveillance, and regulatory requirements.

time_perspective: Other

ipd_sharing: No

lead_sponsor: Tornier, Inc.

location_country: France Switzerland


title: Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes

summary: This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Zimmer Biomet

location_country: Slovenia France

location_facility:
Hôpital Renée Sabran
CHU Lapeyronie
Hospital Novo Mesto
CHU Cote de Nacre


title: Effect of Starter Formula With Symbiotic on Microbiota Balance

summary: The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.

location_country: France Poland

location_facility:
Hôpital Nord
The Medical University of Warsaw
Hôpital de la Conception
Hôpital Saint Joseph


title: Study of Prognosis Value of Protein S100Beta and Copeptine in Seizure in the Emergency Department

acronym: BISTRO

summary: We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

lead_sponsor: Bistro Study Group

location_country:
United Kingdom
France

location_facility: Royal London Hospital, Barts Health NHS Trust


title: Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)

acronym: AIMM

summary:
The objective of the present trial is:

to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma.
to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP
to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

status: Withdrawn

lead_sponsor: Onxeo

location_facility: Hôpital Saint Louis. Service de dermatologie


title: Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With Velcade® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)

summary:
Primary Objectives:

Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor 1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients with recurrent, refractory multiple myeloma (MM).

Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade®.

Secondary Objectives :

Study Part 1:

To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs)
To assess the biological activity of AVE1642 (saturation of the receptors and down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells (PBMC) and granulocytes
To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1 system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells when technically possible
To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3
To assess clinical efficacy (complete response [CR], partial response [PR], minimal response [MR] and stabilization) based on the European group for Blood and Marrow Transplantation (EBMT) criteria, when possible
To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642

Study Part 2:

To detect any PK or PD interaction between AVE1642 and Velcade®
To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria when appropriate
To assess biological activity of AVE1642 in combination with Velcade® on malignant plasma cells collected from bone marrow aspirates: saturation and down-regulation of the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway of the IGF-1 system (pAkt, pErk) when feasible
To detect immunogenicity reaction (HAHA)
To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active

lead_sponsor: Sanofi

location_country: Italy France

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 250003


title: Characterization of the Mechanisms of Action of Resistance to Azacitidine in High-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia With Multilineage Dysplasia

summary:
Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71 years). IPSS classification defines low risk (Low and Intermediate 1), and high risk (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been mainly achieved through a rigorous empirical and clinical research, but the molecular mechanisms by which this molecule exerts its effects remain poorly characterized. The primary mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that favor traduction inhibition. The impact of this molecule on various cell death programs involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly known.

The research program and clinical studies we proposed focus on two major aspects:

- Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of apoptosis versus autophagy.

- Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce different types of cell death (apoptosis or autophagy).

ReferenceCitation: Cluzeau T, Robert G, Mounier N, Karsenti JM, Dufies M, Puissant A, Jacquel A, Renneville A, Preudhomme C, Cassuto JP, Raynaud S, Luciano F, Auberger P. BCL2L10 is a predictive factor for resistance to azacitidine in MDS and AML patients. Oncotarget. 2012 Apr;3(4):490-501.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Monaco France

location_facility:
Centre Antoine Lacassagne
CH d'Antibes
CHU de Nice - Hôpital de l'Archet
CH Princesse Grace


title: Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy

acronym: CHECKMATE

summary:
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease. Heart transplantation remains the reference treatment for the terminal stage of the disease but although this is an effective therapy, it does engender ethical, social, economic and legal problems. It also requires irreproachable and costly logistics, immuno-suppressor treatment and a lifetime of follow-ups. In particular, the number of donors has been going down steadily for several years in most countries which offer a heart transplant programme and some patients cannot take advantage of being added to a waiting list for a graft (age, co-morbidities…).

It is in this context that, alongside the medical treatments for cardiac insufficiency, other therapeutic strategies were developed, including resynchronization and long-term mechanical circulatory support. The progress made in resynchronization is at several levels: better understanding of the action mechanisms, the development and improvement of equipment specifically dedicated to resynchronization and prospective and randomized clinical trials which have scientifically validated this technique.

Simultaneously, many studies were published evaluating long term support with mechanical circulatory support (MCS), excluding light devices, as a bridge to transplant or an alternative to a transplant. It is also recognized that mechanical circulatory support with a new generation of continuous flow assist device improved the quality of life and functional capacity, with a reduced risk of device failure and infrequent need for replacement.

The "Achilles heel" of cardiac resynchronization remains the 20 to 40% of patients who respond barely or not at all. Among this population of patients, some are not candidates for a transplantation and long-term mechanical circulatory support by axial pump is an alternative to be considered. We elaborated an original randomized pilot study for these patients in order to evaluate their survival and their quality of life, to define if they should be proposed a left ventricular assist device (LVAD)or not.

location_country: Germany France

location_facility: Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität

intervention_type: Device


title: A Prospective Multicenter, Study to Evaluate the Safety and Effectiveness of the Presbyopia Algorithm for Hyperopia and Hyperopic Astigmatism Using LASIK

acronym: PresbyLASIK

summary: The Presbyopia Algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance correction). The treatment algorithm provides a bilateral, multifocal ablation with a center near addition, thereby allowing good focus over a range of object distances.

lead_sponsor: Technolas Perfect Vision GmbH

location_country: France Spain

location_facility:
Clinique de la Vision Paris
Vision Future Nice
Instituo Oftalmologico Casteanera
Dr. Roure


title: A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's Disease

acronym: Foehn

summary: The purpose of this study is to determine whether Fipamezole is effective in the treatment of orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's disease.

lead_sponsor: Juvantia Pharma Ltd

location_country: France Portugal

location_facility: Hôpital du Haut Lévêque, CHU de Bordeaux

location_facility: Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa


title: Evaluation of Acupression's Bracelets Associated to an Educational Step Versus Education Only in Nausea and Vomiting's Mastering Induced by FEC100 Chemotherapy's Sort.

summary: The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.

primary_purpose: Prevention

lead_sponsor: Institut Claudius Regaud

location_facility:
Centre Paul STRAUSS
Institut Claudius Regaud
Centre Oscar Lambret


title: An Open Label Parallel Group Study To Investigate The Pharmacokinetics Of Intravenous Linezolid, An Oxazolidinone, Administered To Healthy Volunteers And Patients With Major Thermal Injuries

summary: Evaluation of linezolid pk profile in burns patients

lead_sponsor: Pfizer


title: Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS)

acronym: LAM-RAPA

summary: These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.

ReferenceType: background

ReferenceCitation: Récher C, Beyne-Rauzy O, Demur C, Chicanne G, Dos Santos C, Mas VM, Benzaquen D, Laurent G, Huguet F, Payrastre B. Antileukemic activity of rapamycin in acute myeloid leukemia. Blood. 2005 Mar 15;105(6):2527-34. Epub 2004 Nov 18.

lead_sponsor: University Hospital, Toulouse

location_facility: Service d'Hématologie, Hôpital Jean Minjoz


title: Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion

summary: The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.

ReferenceCitation: Perrotin F, Potin J, Haddad G, Sembely-Taveau C, Lansac J, Body G. Fetal ovarian cysts: a report of three cases managed by intrauterine aspiration. Ultrasound Obstet Gynecol. 2000 Dec;16(7):655-9. Review.

ReferenceCitation: Perrotin F, Roy F, Potin J, Lardy H, Lansac J, Body G. [Ultrasonographic diagnosis and prenatal management of fetal ovarian cysts]. J Gynecol Obstet Biol Reprod (Paris). 2000 Apr;29(2):161-9. French.

location_facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital


title: Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor

summary: The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen

location_facility:
Institut Claudius Regaud
Institut Val d'Aurelle_ Paul Lamarque
Institut Bergonie


title: Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer

summary:
In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph nodes involvement. The initial treatment taking is determined by lymph node evaluation.

Early stage cervical cancers at their very beginning, with no lymph node involvement, will be treated either by surgery only or by radiotherapy only, or by both at the same time. At advanced stages, from proximal IB to IIB with bad prognosis (tumour larger than 4 cm and pelvic lymph node involvement), as well as for cancers up to distal stages IIB, III and IVA, treatment relies on radio-chemotherapy, either alone or pre-surgery.

The pre-therapeutic complete examination of the cervical cancer includes a clinical examination and a pelvic MRI in order to look for pelvic and para-aortic lymph nodes and to precise the volume and the spreading of the tumour in the pelvic area.

A meta-analysis estimating the interest of the MRI showed a variable sensitivity and a specificity for the detection of such lymph node metastasis with a sensitivity varying from 24 to 75 % and a specificity between 84 and 100 % according to the studies.

As for the use of an 18-FDG PET scan to detect lymph node involvement, the studies realized so far are performed, usually, on a small number of subjects and with heterogeneous populations. However, it seems that such an examination enables a better detection of lymph nodes than the MRI does, especially for para-aortic lymph nodes depending on the studies, sensitivity varies from 57 to 100 %, and specificity between 92 and 100 %.

We propose a prospective, multicentric and multidisciplinary study for the estimation of diagnosis methods. The main aim is to estimate the interest of the 18-FDG PET scan for the detection of pelvic and para-aortic lymph node metastasis in patients with cervical cancer, in comparison with the MRI. This study should enable to include 380 patients within 3 years. An 18-FDG scintigraphy will be performed before any treatment together with an MRI. A comparison between the sensitivity and the specificity of both examinations will be established and a correlation with the histology of the lymph node dissection will be made.

ReferenceCitation: Monteil J, Maubon A, Leobon S, Roux S, Marin B, Renaudie J, Genet D, Fermeaux V, Aubard Y, Tubiana-Mathieu N. Lymph node assessment with (18)F-FDG-PET and MRI in uterine cervical cancer. Anticancer Res. 2011 Nov;31(11):3865-71.

lead_sponsor: University Hospital, Limoges

location_facility:
Gynécologie Obstétrique
Médecine Nucléaire
Oncologie Médicale


title: Larynx Preservation With Induction Chemotherapy (Cisplatin, 5FU, Docetaxel) Followed by Radiotherapy Combined With Either Cisplatin or Cetuximab in Laryngopharyngeal Squamous Cell Carcinoma - A Randomised Phase II Study

summary: Larynx preservation remains a very challenging approach in patients with larynx/pharynx cancer. A first attempt consisted of induction chemotherapy followed in good responders by irradiation. This approach allowed to preserve 60 % of the larynx without any significant difference in survival. The second attempt consisted of concurrent chemo-irradiation. This approach provided a higher larynx preservation rate but survival remained unchanged and mucosal toxicity was also higher. A third approach is currently under evaluation: induction chemotherapy followed by concurrent chemo-irradiation in good responders.

ReferenceCitation: Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. doi: 10.1200/JCO.2012.42.3988. Epub 2013 Jan 22. Erratum in: J Clin Oncol. 2013 May 1;31(13):1702.

name: Jean Louis Lefebvre and Marian Degardin, Centre Oscar Lambret; Dominique Chevalier, Centre Hospitalier Universitaire Claude Huriez, Lille; Yoann Pointreau, Gilles Calais, and Pascal Garaud, Centre Hospitalier Universitaire Pierre Bretonneau, Tours; Frederic Rolland and Etienne Bardet, Institut de Cancerologie de l'Ouest Rene Gauducheau; Olivier Malard, Centre Hospitalier Universitaire Hotel Dieu, Nantes; Marc Alfonsi, Institut Sainte Catherine, Avignon; Christian Sire, Centre Hospitalier Bretagne Sud,...

family: Lefebvre

full_name: Jean Louis Lefebvre

given: Jean Louis

family: Pointreau

full_name: Yoann Pointreau

given: Yoann

family: Rolland

full_name: Frederic Rolland

given: Frederic

family: Alfonsi

full_name: Marc Alfonsi

given: Marc

family: Baudoux

full_name: Alain Baudoux

given: Alain

family: Sire

full_name: Christian Sire

given: Christian

family: de Raucourt

full_name: Dominique de Raucourt

given: Dominique

family: Malard

full_name: Olivier Malard

given: Olivier

family: Degardin

full_name: Marian Degardin

given: Marian

family: Tuchais

full_name: Claude Tuchais

given: Claude

family: Blot

full_name: Emmanuel Blot

given: Emmanuel

family: Rives

full_name: Michel Rives

given: Michel

family: Reyt

full_name: Emile Reyt

given: Emile

family: Tourani

full_name: Jean Marc Tourani

given: Jean Marc

family: Geoffrois

full_name: Lionel Geoffrois

given: Lionel

family: Peyrade

full_name: Frederic Peyrade

family: Guichard

full_name: Francois Guichard

given: Francois

family: Chevalier

full_name: Dominique Chevalier

family: Babin

full_name: Emmanuel Babin

family: Lang

full_name: Philippe Lang

given: Philippe

family: Janot

full_name: Francois Janot

family: Calais

full_name: Gilles Calais

given: Gilles

family: Garaud

full_name: Pascal Garaud

given: Pascal

family: Bardet

full_name: Etienne Bardet

title: Induction Chemotherapy Followed by Either Chemoradiotherapy or Bioradiotherapy for Larynx Preservation: The TREMPLIN Randomized Phase II Study

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
CHU de Tours
Centre René Gauducheau
Centre Oscar Lambret


title: A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma

summary: Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Gustave Roussy
Centre Alexis Vautrin
Centre Jean Perrin


title: Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone

summary: Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.

ReferenceCitation: Tunkel AR, Hartman BJ, Kaplan SL, Kaufman BA, Roos KL, Scheld WM, Whitley RJ. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004 Nov 1;39(9):1267-84. Epub 2004 Oct 6.

ReferenceCitation: de Gans J, van de Beek D; European Dexamethasone in Adulthood Bacterial Meningitis Study Investigators. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002 Nov 14;347(20):1549-56.

ReferenceCitation: Auburtin M, Porcher R, Bruneel F, Scanvic A, Trouillet JL, Bédos JP, Régnier B, Wolff M. Pneumococcal meningitis in the intensive care unit: prognostic factors of clinical outcome in a series of 80 cases. Am J Respir Crit Care Med. 2002 Mar 1;165(5):713-7.

ReferenceCitation: Viladrich PF, Gudiol F, Liñares J, Pallarés R, Sabaté I, Rufí G, Ariza J. Evaluation of vancomycin for therapy of adult pneumococcal meningitis. Antimicrob Agents Chemother. 1991 Dec;35(12):2467-72.

ReferenceCitation: Ricard JD, Wolff M, Lacherade JC, Mourvillier B, Hidri N, Barnaud G, Chevrel G, Bouadma L, Dreyfuss D. Levels of vancomycin in cerebrospinal fluid of adult patients receiving adjunctive corticosteroids to treat pneumococcal meningitis: a prospective multicenter observational study. Clin Infect Dis. 2007 Jan 15;44(2):250-5. Epub 2006 Dec 15.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Réanimation Médicale, CHU Bichat

location_facility: Service de Réanimation Médicale, CHU Louis Mourier

location_facility: Service de Réanimation Médicale, CHI Poissy-St-Germain


summary: Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.

lead_sponsor: University Hospital, Angers

location_facility: Neurosurgical intensive care. CHU Le Kremlin Bicêtre

location_facility: Neurosurgical intensive care. CHU de Nancy


title: Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir

summary: Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

ReferenceCitation: Rozenberg S, Lanoy E, Bentata M, Viard JP, Valantin MA, Missy P, Darasteanu I, Roux C, Kolta S, Costagliola D; ANRS 120 Fosivir Study Group. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012 Sep;28(9):972-80. Epub 2012 Mar 23.

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

location_facility: Hôpital Necker service des Maladies Infectieuses

location_facility: Service de Rhumatologie hopital Pitie-Salpetriere

location_facility: Service de Medecine Interne hopital Avicenne


title: Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.

ReferenceCitation: Ducreux M, Ychou M, Laplanche A, Gamelin E, Lasser P, Husseini F, Quenet F, Viret F, Jacob JH, Boige V, Elias D, Delperro JR, Luboinski M; gastrointestinal group of the Federation Nationale des Centres de Lutte Contre le Cancer. Hepatic arterial oxaliplatin infusion plus intravenous chemotherapy in colorectal cancer with inoperable hepatic metastases: a trial of the gastrointestinal group of the Federation Nationale des Centres de Lutte Contre le Cancer. J Clin Oncol. 2005 Aug 1;23(22):4881-7. Epub 2005 Jul 11.

lead_sponsor: UNICANCER

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


title: Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis

acronym: Cough-IPF

summary: In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice. The hypothesis is that Pirfenidone will decrease cough and increase quality of life.

lead_sponsor: Erasmus Medical Center

location_country: Italy France Netherlands

location_facility: University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel

location_facility: Regional Centre for Rare Lung Disease University of Catania.

location_facility: Erasmus MC Rotterdam, Dep. of Pulmonology


title: Effectiveness and Organizational Conditions of Effectiveness of Telemedicine in Establishments Providing Care for the Dependent Elderly

acronym: EFFORT

summary: Study of interest of Telemedicine in establishments providing care for the dependent elderly (EHPAD in french) is a strategy for improving the course of care of residents, including the number not programmed hospitalizations, and a multidimensional analysis of the conditions of effectiveness of telemedicine will identify the keys to optimize its use.

ReferenceCitation: Han JH, Morandi A, Ely EW, Callison C, Zhou C, Storrow AB, Dittus RS, Habermann R, Schnelle J. Delirium in the nursing home patients seen in the emergency department. J Am Geriatr Soc. 2009 May;57(5):889-94. doi: 10.1111/j.1532-5415.2009.02219.x.

family: Han

full_name: Jin H. Han

given: Jin H.

family: Morandi

full_name: Alessandro Morandi

given: Alessandro

family: Ely

full_name: E. Wesley Ely

given: E. Wesley

family: Callison

full_name: Clay Callison

given: Clay

family: Zhou

full_name: Chuan Zhou

given: Chuan

family: Storrow

full_name: Alan B. Storrow

given: Alan B.

family: Dittus

full_name: Robert S. Dittus

given: Robert S.

family: Habermann

full_name: Ralf Habermann

given: Ralf

family: Schnelle

full_name: John Schnelle

given: John

journal_name: Journal of the American Geriatrics Society

oa_host_type: repository

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: Delirium in the Nursing Home Patients Seen in the Emergency Department

ReferenceCitation: Morandi A, Han JH, Callison C, Ely EW, Schnelle JF. Delirium in nursing home residents across care transitions: a preliminary report. J Am Geriatr Soc. 2009 Oct;57(10):1956-8. doi: 10.1111/j.1532-5415.2009.02472.x.

full_name: John F. Schnelle

given: John F.

title: Delirium in Nursing Home Residents Across Care Transitions: A Preliminary Report

ReferenceCitation: Vellas B. Integrating Frailty into Clinical Practice to Prevent the Risk of Dependency in the Elderly. Nestle Nutr Inst Workshop Ser. 2015;83:99-104. doi: 10.1159/000382092. Epub 2015 Oct 20. Review.

journal_name: Frailty: Pathophysiology, Phenotype and Patient Care

ReferenceCitation: Graverholt B, Forsetlund L, Jamtvedt G. Reducing hospital admissions from nursing homes: a systematic review. BMC Health Serv Res. 2014 Jan 24;14:36. doi: 10.1186/1472-6963-14-36. Review.

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Salles N, Saillour-Glénisson F, Sibe M, Langlois E, Kret M, Durrieu J, Arditi N, Abraham M, Perry F. Effectiveness and organizational conditions of effectiveness of telemedicine in nursing homes. A study protocol of a comparative prospective cohort (EFFORT study). Digit Health. 2021 Jan 24;7:2055207620982422. doi: 10.1177/2055207620982422. eCollection 2021 Jan-Dec.

name: Pole de Gérontologie Clinique, CHU Bordeaux, Bordeaux, France

name: Unité de Soutien Méthodologique à la Recherche Clinique et Épidémiologique du CHU de Bordeaux, Bordeaux, France

name: Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Université de Bordeaux, Bordeaux, France

name: Centre Emile Durkheim, Science Politique et Sociologie Comparatives (UMR 5116), Université de Bordeaux, Bordeaux, France

name: Recherche Clinique et de l’Innovation, CHU Bordeaux, Bordeaux, France

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

location_facility:
Résidence de Médicis
EHPAD Résidence les Carmes
EHPAD Manon Cormier
EHPAD Seguin
EHPAD Grand Bon Pasteur
EHPAD Le rétou
EHPAD Le Platane du Grand Parc
EHPAD CHU Bordeaux
EHPAD Residence Aime Cesaire
EHPAD résidence du Tertre
EHPAD Résidence La berge du lac
EHPAD Henry Dunant
EHPAD Les coteaux
EHPAD Villa Bontemps
EHPAD Jacqueline Auriol
EHPAD Home Marie Curie
EHPAD Le Clos Serena
EHPAD Résidence l'Arousiney
EHPAD Fontaudin
EHPAD Le parc du Bequet
EHPAD Le home medocain Arsac
EHPAD Villa presentine
EHPAD Cos villa Pia
EHPAD Douceur de France


title: Long-Term Observational Study of Translarna Safety and Effectiveness in Usual Care

summary: This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.

ReferenceCitation: Mercuri E, Muntoni F, Osorio AN, Tulinius M, Buccella F, Morgenroth LP, Gordish-Dressman H, Jiang J, Trifillis P, Zhu J, Kristensen A, Santos CL, Henricson EK, McDonald CM, Desguerre I; STRIDE; CINRG Duchenne Natural History Investigators. Safety and effectiveness of ataluren: comparison of results from the STRIDE Registry and CINRG DMD Natural History Study. J Comp Eff Res. 2020 Apr;9(5):341-360. doi: 10.2217/cer-2019-0171. Epub 2020 Jan 30.

name: Department of Pediatric Neurology, Catholic University, Rome, Italy

name: Centro Clinico Nemo, Policlinico Universitario A Gemelli IRCCS, Rome, Italy

family: Mercuri

full_name: Eugenio Mercuri

given: Eugenio

name: Dubowitz Neuromuscular Centre & MRC Centre for Neuromuscular Diseases, University College London, Institute of Child Health & Great Ormond Street Hospital for Children Foundation Trust, 30 Guildford Street, London, WC1N 1EH, UK

name: NIHR Great Ormond Street Hospital Biomedical Research Centre, Great Ormond Street Institute of Child Health, University College London, Great Ormond Street Hospital Trust, London, UK

family: Muntoni

full_name: Francesco Muntoni

given: Francesco

name: Hospital Sant Joan de Déu Unidad de Patología Neuromuscular, Universidad de Barcelona, CIBERER, ISCIII, Barcelona, Spain

family: Osorio

full_name: Andrés Nascimento Osorio

given: Andrés Nascimento

name: Department of Pediatrics, Gothenburg University, Queen Silvia Children’s Hospital, Gothenburg, Sweden

family: Tulinius

full_name: Már Tulinius

given: Már

family: Buccella

full_name: Filippo Buccella

given: Filippo

name: Therapeutic Research in Neuromuscular Disorders Solutions, Pittsburgh, PA, USA

family: Morgenroth

full_name: Lauren P Morgenroth

given: Lauren P

name: Center for Genetic Medicine, Children’s National Health System & the George Washington, Washington, DC, USA

family: Gordish-Dressman

full_name: Heather Gordish-Dressman

given: Heather

name: PTC Therapeutics Inc., South Plainfield, NJ 07080-2449, USA

family: Jiang

full_name: Joel Jiang

given: Joel

family: Trifillis

full_name: Panayiota Trifillis

given: Panayiota

family: Zhu

full_name: Jin Zhu

given: Jin

family: Kristensen

full_name: Allan Kristensen

given: Allan

family: Santos

full_name: Claudio L Santos

given: Claudio L

name: University of California Davis School of Medicine, Davis, CA, USA

family: Henricson

full_name: Erik K Henricson

given: Erik K

family: McDonald

full_name: Craig M McDonald

given: Craig M

name: APHP Necker – Enfants Malades Hospital, Paris V Descartes University, Neuromuscular Network FILNEMUS, Paris, France

family: Desguerre

full_name: Isabelle Desguerre

given: Isabelle

journal_name: Journal of Comparative Effectiveness Research

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

version: submittedVersion

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
air.unimi.it

repositories_institution: University College London - UCL Discovery

location_country:
Italy
Austria
Brazil
Sweden
United Kingdom
France
Czechia
Greece
Israel
Slovenia
Norway
Hungary
Romania
Portugal
Germany
Latvia

location_facility: Sozialmedizinisches Zentrum Süd Kaiser-Franz-Josef Spital mit Gottfried von Preyer´schen Kinderspital

location_facility: UCL Great Ormond Street Institute of Child Health

location_facility: CHU de Toulouse Hôpital Pierre Paul Riquet

location_facility: CHU de la Réunion - GHSR - GH Sud-Réunion

location_facility: Cardiomiologia e Genetica Medica Primo Policlinico

location_facility: CHU de Nancy Hôpital de Brabois-Enfants Rue du Morvan

location_facility: Klinik und Poliklinik f. Kinder- und Jugendmedizin

location_facility: The John Walton Muscular Dystrophy Research Centre

location_facility: Sheba Medical Center The Joseph Sagol EMG, Neuroscience Center

location_facility: Szent László Kórház Gyermekneurológiai szakrendelés

location_facility: University Children's Hospital University Medical Centre Ljubljana

location_facility: Sozialpädiatrisches Zentrum (SPZ) Charité Berlin

location_facility: CHU de Clermont-Ferrand, hôpital Estaing

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: CHU de Bordeaux Hôpital Pellegrin Enfant

location_facility: Centro Hospitalar e Universitário de coimbra EPE - Hospital Pediátrico de Coimbra

location_facility: CHU de Martinique - Hôpital P. Zobda-Quitman

location_facility: Centro Hospitalar do Porto EPE - Hospital Geral de Santo António

location_facility: Schneider Medical Center Tel Aviv University

location_facility: II Policlinico Neurofisiopatologia (Edificio 11 G)

location_facility: NIHR Lancashire Clinical Research Facility Royal Preston Hospital

location_facility: Ospedale Molinette SCDU Neuropsichiatria Infantile AO Città della Salute e della Scienza di Torino

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Göteborgs Universitet Avdelningen för pediatrik vid institutionen för kliniska vetenskaper

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria

location_facility: Spitalul Clinic de Copii "Dr. Victor Gomoiu" Sectia Clinica Neurologie Pediatrica

location_facility: Children Hospital - Children's Neurosciences Leeds TEACHING HOSPITALS NHS Trust

location_facility: St. Olavs hospital University children's clinical hospital

location_facility: IRCSS Istituto delle Scienze Neurologiche

location_facility: Children's Hospital Alder Hey Children's Hospital NHS Trust

location_facility: Hospices Civils de Lyon Groupement Hospitalier Est - Bâtiment "Les Tilleuls"

location_facility: Hospital das Clínicas da Universidade de São Paulo

location_facility: Semmelweis Egyetem II (Semmelweis University II)


title: Comparative Assessment of Methods to Analyze MGMT as a Predictive Factor of Response to Temozolomide in Glioblastomas.

acronym: ECOM

summary: Treatment for newly diagnosed glioblastomas currently involves surgical resection followed by Temozolomide chemotherapy with concomitant radiotherapy, and then 6 cycles of Temozolomide in adjuvant. According to many studies, only those patients not expressing the enzyme repair MGMT benefit from the adjunction of Temozolomide. Therefore, many patients receive unnecessary treatment. The aim of this project is to compare different techniques for analysis of MGMT in order to choose the approach with the best cost/utility ratio, which will allow the selection of patients likely to respond to TMZ chemotherapy during the first course of GBM treatment.

ReferenceCitation: Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003.

ReferenceCitation: Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96.

lead_sponsor: Center Eugene Marquis

location_facility:
CHU de Lyon
Center Eugene Marquis
CHRU Hautepierre
CHRU de Lille
CHU de Bordeaux
CHU de Poitiers
CHU La Timone
CHU de Grenoble
CHU La Salpetriere
CHU Cote de Nacre

intervention_type: Radiation