title: The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

acronym: BPCeaux

summary: The primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment). An exacerbation is defined by an increase in symptoms which justifies a unscheduled medical action: increased daily treatment and / or use of corticosteroids, and / or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation reports or unscheduled visits.

location_facility:
Private practice: Karim Berkani
Private practice: Marc Bellier
Private practice: Jean Hérété
Private practice: Pierre Olivier
Private practice: Muriel Nouvelle
Private practice: Pierre Ethève


title: Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation

summary:
The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.

Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hospices Civils de Lyon
CHU Limoges
CHU de Clermont-Ferrand
CH Issoire
CHU Grenoble
CHU Dijon

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


type: Registry Identifier

type: Other Identifier

title: A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas

summary: This phase II trial studies how well vismodegib works in treating patients with chondrosarcomas that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

study_start_date_type: Actual

status: Active, not recruiting

study_type: Interventional

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Italiano A, Le Cesne A, Bellera C, Piperno-Neumann S, Duffaud F, Penel N, Cassier P, Domont J, Takebe N, Kind M, Coindre JM, Blay JY, Bui B. GDC-0449 in patients with advanced chondrosarcomas: a French Sarcoma Group/US and French National Cancer Institute Single-Arm Phase II Collaborative Study. Ann Oncol. 2013 Nov;24(11):2922-6. doi: 10.1093/annonc/mdt391.

family: Italiano

full_name: A. Italiano

given: A.

sequence: first

family: Le Cesne

full_name: A. Le Cesne

sequence: additional

family: Bellera

full_name: C. Bellera

given: C.

family: Piperno-Neumann

full_name: S. Piperno-Neumann

given: S.

family: Duffaud

full_name: F. Duffaud

given: F.

family: Penel

full_name: N. Penel

given: N.

family: Cassier

full_name: P. Cassier

given: P.

family: Domont

full_name: J. Domont

given: J.

family: Takebe

full_name: N. Takebe

family: Kind

full_name: M. Kind

given: M.

family: Coindre

full_name: J.-M. Coindre

family: Blay

full_name: J.-Y. Blay

family: Bui

full_name: B. Bui

given: B.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: National Cancer Institute (NCI)

location_facility:
Institut Curie Paris
Centre Oscar Lambert
Centre Leon Berard
Gustave Roussy
Hopital De La Timone
Institut Bergonie Cancer Center

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function

acronym: RectoVerso

summary: The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.

status: Terminated

design_allocation: Randomized

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Hôpital Paule de Viguier, CHU de Toulouse

intervention_type: Procedure

status_simplified: Unknown


title: Prospective Multicentric Optimization and Phase I/II Study of Pretargeted Radioimmunotherapy (PRAIT) Using Anti-CEA x Anti-HSG TF2 Bispecific Antibody (bsMAb) and 177Lu-IMP-288 Peptide in Patients With CEA-expressing Small Cell Lung Carcinoma (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)

summary: Lung cancer is currently the leading cause of cancer death in both men and women in Europe, with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients indicates that the current recommended regimens are falling short. In addition, many of the commonly used chemotherapy agents are associated with severe nonhematologic toxicities that are often cumulative and nonreversible and impair quality of life in this essentially palliative setting. Therefore, agents with novel mechanisms of action and superior safety profiles need to be investigated. More than 50% of lung cancer shows carcinoembryonic antigen (CEA) expression and anti-CEA radioimmunotherapy (RAIT) could be used. The investigators group showed that pretargeted RAIT (PRAIT) using bispecific antibody (bsMAb) can deliver a higher radiation dose to a tumor than a directly radiolabeled anti-CEA antibody, and shows improved anti-tumor efficacy. This clinical trial is designed to assess PRAIT using an entirely new recombinant anti-CEA bsMAb and a 177Lu-labeled peptide for the treatment of CEA-expressing small cell lung cancers (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)

ReferenceCitation: Bodet-Milin C, Ferrer L, Rauscher A, Masson D, Rbah-Vidal L, Faivre-Chauvet A, Cerato E, Rousseau C, Hureaux J, Couturier O, Salaün PY, Goldenberg DM, Sharkey RM, Kraeber-Bodéré F, Barbet J. Pharmacokinetics and Dosimetry Studies for Optimization of Pretargeted Radioimmunotherapy in CEA-Expressing Advanced Lung Cancer Patients. Front Med (Lausanne). 2015 Nov 27;2:84. doi: 10.3389/fmed.2015.00084. eCollection 2015.

family: Bodet-Milin

full_name: Caroline Bodet-Milin

given: Caroline

family: Ferrer

full_name: Ludovic Ferrer

given: Ludovic

family: Rauscher

full_name: Aurore Rauscher

given: Aurore

family: Masson

full_name: Damien Masson

given: Damien

family: Rbah-Vidal

full_name: Latifa Rbah-Vidal

given: Latifa

family: Faivre-Chauvet

full_name: Alain Faivre-Chauvet

given: Alain

family: Cerato

full_name: Evelyne Cerato

given: Evelyne

family: Rousseau

full_name: Caroline Rousseau

family: Hureaux

full_name: José Hureaux

given: José

family: Couturier

full_name: Olivier Couturier

given: Olivier

family: Salaün

full_name: Pierre-Yves Salaün

given: Pierre-Yves

family: Goldenberg

full_name: David M. Goldenberg

given: David M.

family: Sharkey

full_name: Robert M. Sharkey

given: Robert M.

family: Kraeber-Bodéré

full_name: Françoise Kraeber-Bodéré

given: Françoise

family: Barbet

full_name: Jacques Barbet

given: Jacques

currency_apc_doaj: USD

journal_name: Frontiers in Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Centre René Gauducheau

location_facility:
CHU d'Angers
Centre Jean Perrin
Hotel Dieu
Hôpital La tronche
Centre René Gauducheau
CHU

intervention_type: Radiation


title: CLINICAL MULTICENTER STUDY OF PHASE II AND RADIOBIOLOGY ASSESSING Hypofractionated Stereotactic Radiotherapy With Irinotecan (Campto) IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer

acronym: RS CAMPTO

summary: The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).

ipd_sharing: No

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Léon Berard
Hôpital Saint André
Centre Oscar Lambret
Centre hospitalier Lyon Sud
Centre René Gauducheau
Hôpital la Source


title: Construction and Validation of a Short Screening Scale for Psychotraumatic Disorders for Inpatients Hospitalized in Surgical Unit Following a Road Traffic Accident

acronym: DEPITAC

summary:
Posttraumatic stress disorder (PTSD) is a serious and often chronic response to overwhelmingly stressful events as Road Traffic Accident. Moreover PTSD is associated with increased rates of medical morbidity, poor health-related quality of life, and functional impairment. PTSD is prevalent in primary care settings after road traffic accident, where approximately 25% of patients meet diagnostic criteria for the disorder. Despite the development of a number of efficacious behavioral and pharmacological treatments, only a minority of patients with PTSD receive mental health services. PTSD is frequently underrecognized and untreated in Emergency Department and Surgical Unit.

Then, early diagnosis and prevention of PTSD might help to identify patients with PTSD high risk and lead them to benefit of personalized cares. Nevertheless it is not possible (neither useful) to provide psychological cares for each road traffic accident victim.

This is the reason why we think that nurses can help to screen patients who need treatment for PTSD Hypothesis : Recognition of specific clinical or biological signs occurring during road traffic accident victim hospitalization in surgical unit could allow beginning specific treatment using consultation liaison psychiatry.

Early treatment could allow decreasing incidence of psychotraumatic disorders, increasing surgical functional efficacy and improve convalescence programs. The use of a specific questionnaire could help to screen this disorder.

We have created the DEPITAC scale : a short screening questionnaire with 10 items.

This study will be evaluated DEPITAC's 10-item screen for posttraumatic stress disorder (PTSD) for use in surgical or emergency department.

lead_sponsor: University Hospital, Lille

location_facility: Georges Pompidou European Hospital, Paris

location_facility: Catholic University Hospital of Lille Saint Philibert

location_facility: Catholic University Hospital of Lille Saint Vincent

intervention_type: Behavioral


title: Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates in Mechanically Ventilated Patients Receiving Early Enteral Feeding: a Randomized-controlled Study

summary: Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.

primary_purpose: Prevention

ReferenceCitation: Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.

family: Reignier

full_name: Jean Reignier

given: Jean

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Not Monitoring Residual Gastric Volume on Risk of Ventilator-Associated Pneumonia in Adults Receiving Mechanical Ventilation and Early Enteral Feeding

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CH Angoulème - Réanimation Polyvalente
CHU Orléans - Réanimation Médicale
CHD Vendée - Service de Réanimation
CHU Limoges - Réanimation Polyvalente
CHU Tours - Réanimation Polyvalente
CHU Poitier - Réanimation Médicale


intervention_type: Drug

status: Suspended

lead_sponsor: University Hospital, Limoges

enrollment_type: Anticipated

primary_purpose: Supportive Care

acronym: TALViSoP

location_facility: Centre Hospitalier Universitaire - Hôpital Saint André

study_completion_date_type: Anticipated

source: euctr

title: Procedures of Locoregional Analgesia and Quality of Life in Palliative Care

summary:
Number of patients in mobile palliative care units have pain of both nociceptive and neuropathic origin. In certain cases, procedures of locoregional analgesia can be helpful.

The Purpose of this study is to evaluate the impact of techniques of locoregional analgesia in a palliative population


title: Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study

acronym: ICUP

summary: The hypothesis is that the new vacuum assisted delivery device iCup is more effective than the reference cup, in terms of maternal and newborn morbidities and functioning

ReferenceType: background

ReferenceCitation: Chalmers JA, Chalmers I. The obstetric vacuum extractor is the instrument of first choice for operative vaginal delivery. Br J Obstet Gynaecol. 1989 May;96(5):505-6.

ReferenceCitation: Johanson R, Menon V. Soft versus rigid vacuum extractor cups for assisted vaginal delivery. Cochrane Database Syst Rev. 2000;(2):CD000446. Review. Update in: Cochrane Database Syst Rev. 2010;(11):CD000446.

ReferenceCitation: Miksovsky P, Watson WJ. Obstetric vacuum extraction: state of the art in the new millennium. Obstet Gynecol Surv. 2001 Nov;56(11):736-51. Review.

ReferenceCitation: Schaal JP, Riethmuller D, Menget A. Extractions instrumentales du fœtus : ventouse obstétricale. Encycl Méd Chir Paris: Elsevier, 2004 (vol Obstétrique)

ReferenceCitation: Attilakos G, Sibanda T, Winter C, Johnson N, Draycott T. A randomised controlled trial of a new handheld vacuum extraction device. BJOG. 2005 Nov;112(11):1510-5.

ReferenceCitation: Vacca A. A randomised controlled trial of a new handheld vacuum extraction device. BJOG. 2006 Apr;113(4):492; author reply 494-5.

ReferenceCitation: Groom KM, Jones BA, Miller N, Paterson-Brown S. A prospective randomised controlled trial of the Kiwi Omnicup versus conventional ventouse cups for vacuum-assisted vaginal delivery. BJOG. 2006 Feb;113(2):183-9.

ReferenceCitation: Schaal JP, Equy V, Hoffman P. [Comparison vacuum extractor versus forceps]. J Gynecol Obstet Biol Reprod (Paris). 2008 Dec;37 Suppl 8:S231-43. doi: 10.1016/S0368-2315(08)74761-6. French.

ReferenceCitation: Riethmuller D, Ramanah R, Maillet R, Schaal JP. [Vacuum extractors: description, mechanics, indications and contra-indications]. J Gynecol Obstet Biol Reprod (Paris). 2008 Dec;37 Suppl 8:S210-21. doi: 10.1016/S0368-2315(08)74759-8. French.

ReferenceCitation: Verma GL, Spalding JJ, Wilkinson MD, Hofmeyr GJ, Vannevel V, O'Mahony F. Instruments for assisted vaginal birth. Cochrane Database Syst Rev. 2021 Sep 24;9:CD005455. doi: 10.1002/14651858.CD005455.pub3. Review.

name: Department of Obstetrics and Gynaecology; University Hospitals of Leicester; Leicester UK

family: Verma

full_name: Ganga L Verma

given: Ganga L

name: Department of Obstetrics and Gynaecology; University Hospitals of North Midlands; Stoke-on-Trent UK

family: Spalding

full_name: Jessica J Spalding

given: Jessica J

family: Wilkinson

full_name: Marc D Wilkinson

given: Marc D

name: Walter Sisulu University, University of Fort Hare, University of the Witwatersrand, Eastern Cape Department of Health, East London, South Africa & Department of Obstetrics and Gynaecology, University of Botswana; Gaborone Botswana

family: Hofmeyr

full_name: G Justus Hofmeyr

given: G Justus

name: SAMRC Maternal and Infant Health Care Strategies Unit/University of Pretoria; Pretoria South Africa

family: Vannevel

full_name: Valerie Vannevel

given: Valerie

name: Keele University & Department of Obstetrics and Gynaecology, University Hospitals of North Midlands; Stoke-on-Trent UK

family: O'Mahony

full_name: Fidelma O'Mahony

given: Fidelma

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Instruments for assisted vaginal birth

ReferenceCitation: Equy V, David-Tchouda S, Dreyfus M, Riethmuller D, Vendittelli F, Cabaud V, Langer B, Margier J, Bosson JL, Schaal JP. Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial. BMC Pregnancy Childbirth. 2015 Dec 15;15:332. doi: 10.1186/s12884-015-0771-1.

family: Equy

full_name: Véronique Equy

given: Véronique

family: David-Tchouda

full_name: Sandra David-Tchouda

given: Sandra

family: Dreyfus

full_name: Michel Dreyfus

given: Michel

family: Riethmuller

full_name: Didier Riethmuller

given: Didier

family: Vendittelli

full_name: Françoise Vendittelli

family: Cabaud

full_name: Victoire Cabaud

given: Victoire

family: Langer

full_name: Bruno Langer

given: Bruno

family: Margier

full_name: Jennifer Margier

given: Jennifer

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Schaal

full_name: Jean-Patrick Schaal

given: Jean-Patrick

currency_apc_doaj: GBP

journal_name: BMC Pregnancy and Childbirth

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


title: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer: Potential for Diagnosis of Early Neoplasia

summary: The principle objective of this study is to validate confocal endomicroscopy (CEM) in a national, multicenter study, in terms of its ability to diagnose neoplastic lesions in vivo, in two groups of patients at high risk of colorectal cancer (CRC): patients with familial adenomatous polyposis (FAP) after colectomy in whom the neoplastic lesions are probably under-diagnosed, and patients with inflammatory bowel diseases (IBD) in whom endoscopic surveillance is particularly difficult. Methods: The study will be comprised of two phases (Phase I and II). Phase I will serve to validate at the multicenter level the results of the first, recently published, monocenter German study in terms of capacity of CEM to identify the colonic neoplastic lesions in vivo. Phase II is destined to prospectively evaluate the diagnostic yield of CEM in detection and prediction of neoplastic lesions by developing and adding new features to the confocal pattern of in vivo diagnosis. Two cohorts of patients will be studied in parallel: Patients with inflammatory bowel diseases (IBD), like ulcerative colitis (UC) or Crohn's disease (CD), including those before planned colectomy, and patients with FAP after colectomy. During lower endoscopy performed under general anaesthesia, each colonic segment will be examined before and after staining with indigo-carmin. After intra-venous fluorescein injection, all macroscopically abnormal lesions will be examined by CEM, then biopsied. In parallel, multiple random biopsies will be performed, each coupled with simultaneous CEM "optical biopsy" at the same point. In addition, during Phase II, in IBD patients before planned colectomy and in patients with FAP, a "mapping" of colonic mucosa, by obtaining a very high number of CEM "optical biopsies", will be performed, and will be correlated with standard histology performed either on colectomy specimens (IBD) or on standard biopsies (FAP). Principal analysis (Phase I and II) will include evaluation of inter-observer variation in terms of interpretation of in vivo histology and diagnostic yield of CEM with respect to the detection of neoplastic lesions by evaluation of sensitivity and specificity, using standard histology as reference method. Additional analysis (Phase II) will be performed to evaluate the diagnostic and predictive (CRC risk) value of "colonic mapping" by correlating optical images pattern score to results of standard histology. Expected results: This study should guarantee high quality data, standardization of procedures and of interpretation of CEM images, which are prerequisite for dissemination of CEM in clinical practice. The investigators expect to show that CME allows to reliably discriminate between neoplastic and non-neoplastic lesions, that, compared to standard histology, provides better characterization of lesions, especially in the context of extended lesions like in IBD, an finally, that CME images can be used to develop a new "optical biopsy"-based score allowing prediction of high CRC risk in patients with FAP and IBD. The investigators believe that CEM may increase, as compared to currently used techniques, the diagnostic yield in terms of probability of the detection of neoplastic lesions in patients at high risk of CCR, and may become a new standard for endoscopic surveillance in these patients.

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

location_facility:
CHU de Nantes
CHU de Lille
Hôpital Lyon Sud
Institut Paoli Calmettes
Hôpital Saint Philibert
CHU de Toulouse


title: A Phase I, Open-label, Dose-escalating Study of the Safety or Percutaneous Intra-tumoral Injection of TG4023 (MVA-FCU1) Combined With Systemic Administration of 5-fluorocytosine in Patients With Primary or Secondary Hepatic Tumors.

summary: This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.

design_allocation: Non-Randomized

ReferenceCitation: Erbs P, Findeli A, Kintz J, Cordier P, Hoffmann C, Geist M, Balloul JM. Modified vaccinia virus Ankara as a vector for suicide gene therapy. Cancer Gene Ther. 2008 Jan;15(1):18-28. Epub 2007 Nov 9.

ReferenceCitation: Husseini F, Delord JP, Fournel-Federico C, Guitton J, Erbs P, Homerin M, Halluard C, Jemming C, Orange C, Limacher JM, Kurtz JE. Vectorized gene therapy of liver tumors: proof-of-concept of TG4023 (MVA-FCU1) in combination with flucytosine. Ann Oncol. 2017 Jan 1;28(1):169-174. doi: 10.1093/annonc/mdw440.

family: Husseini

full_name: F. Husseini

given: F.

family: Delord

full_name: J.-P. Delord

family: Fournel-Federico

full_name: C. Fournel-Federico

given: C.

family: Guitton

full_name: J. Guitton

given: J.

family: Erbs

full_name: P. Erbs

given: P.

family: Homerin

full_name: M. Homerin

given: M.

family: Halluard

full_name: C. Halluard

family: Jemming

full_name: C. Jemming

family: Orange

full_name: C. Orange

family: Limacher

full_name: J.-M. Limacher

family: Kurtz

full_name: J.-E. Kurtz

lead_sponsor: Transgene

location_facility:
Institut Paoli Calmette,
Hôpitaux Civils de Colmar
Hôpitaux Universitaires de Strasbourg
Institut Claudius Regaud
Centre René Gauducheau
Hôpitaux Civils de Lyon,

intervention_type: Biological


lead_sponsor: Sanofi Pasteur, a Sanofi Company

acronym: Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine

type: EudraCT Number

title: Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects

summary:
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Primary objectives:

To describe the immune response to study vaccine 21 days after each vaccination.
To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
To describe the safety profiles of study vaccines in all participants.


title: Inappropriate Medications and Alzheimer Disease: Prevalence and Associated Factors in Elderly Patients Treated With Anticholinesterase and/or Memantine. MIDA Study.

acronym: MIDA

summary: In each of the 7 French areas that should be involved, patients aged 75 years and over from three different sectors will be included: the geriatric consultation unit (60%) and two kinds of nursing homes, private (20%) and state (10%). Outpatients will be included in chronological order; patients in nursing homes will be included at random. The patients and their families will be asked about the treatments received on the day of inclusion. The inclusion period will extend over a year. The investigating practitioners will be asked to fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and information on the treatment given.

location_facility:
CH Le Mans
CHU Saint Etienne
APHP Charles Foix
CHU Bordeaux
CHU Montpellier
CHU Rouen


ReferenceType: result

ReferenceCitation: Pichon S, Guinet-Morlot F, Minutello M, Donazzolo Y, Rouzier R, Chassard D, Fitoussi S, Hou V. A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from a randomized controlled phase-II trial. Vaccine. 2013 Apr 26;31(18):2295-301. doi: 10.1016/j.vaccine.2013.02.058. Epub 2013 Mar 16.

family: Pichon

full_name: Sylvie Pichon

given: Sylvie

family: Guinet-Morlot

full_name: Françoise Guinet-Morlot

given: Françoise

family: Minutello

full_name: Maria Minutello

given: Maria

family: Donazzolo

full_name: Yves Donazzolo

given: Yves

family: Rouzier

full_name: Regine Rouzier

given: Regine

family: Chassard

full_name: Didier Chassard

family: Fitoussi

full_name: Serge Fitoussi

given: Serge

family: Hou

full_name: Victor Hou

given: Victor

journal_name: Vaccine

title: A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab™ for pre-exposure use in healthy adults: Results from a randomized controlled phase-II trial

title: Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults

summary:
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.

Primary Objective:

To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.

Secondary Objectives:

To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.


title: Neuroactive Steroids and Cognition in Humans: Pregnenolone Sulfate an Early Marker of the Memory Loss Associated With Alzheimer's Disease

acronym: STERMEM

summary: The steroid pregnenolone sulfate (PREGS) may be one of the factors responsible for the memory decline related to normal aging or associated with Alzheimer's disease (AD). The purpose of this study is to determine whether plasma levels of PREGS are decreased patients with at mild to moderate AD compared with AD-free control subjects matched for gender and age and to see whether they are inversely correlated with the severity of memory deficits in AD patients. The hypothesis is that blood levels of PREGS are decreased with advanced age and with the stage of AD that would be positively correlated with memory deficits. Therefore PREGS could be considered as an early marker of the memory deficits in AD.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse

location_facility: Assistance publique - Hôpitaux de Paris Hôpital Bicêtre

location_facility: Assistance Publique - Hôpitaux de Paris Hôpital Broca

location_facility: Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpétrière


title: Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer

summary: The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Eugène Marquis
Centre Paul Papin
Centre Oscar Lambret
Centre Hospitalier Universitaire
Centre François BACLESSE
CHU - Hopital Charles Nicolle


title: Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.

acronym: SEDIC

summary: The purpose of the SEDIC study is to test a home based heart failure patient clinical follow-up and therapeutic education using telemedicine. This educational follow-up is based on an interactive information system (SCAD) including a touch screen personal computer for heart failure patient at home. An interactive algorithm has been developed to allow a self management teaching to the patient.Furthermore, a specialized nurse provide a clinical data follow-up.

lead_sponsor: University Hospital, Caen

location_facility:
Alençon-Mamers Hospital
Caen University Hospital
Saint-Lo Hospital
Cherbourg Hospital
Lisieux Hospital
Flers Hospital


title: A Phase II Open-label, Multicenter, Non Randomized Study Evaluating the Efficacy and the Safety of Clofarabine in Combination With IV Busulfan and Thymoglobulin (CBT) as a Reduced Intensity Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Adult Patients With High-risk AML, MDS or ALL.

acronym: Cloric

summary: Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its efficacy in treating aggressive acute leukemias. In addition, evidence is that it is well-tolerated with manageable side effects especially in elderly patients. Thus, replacing Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen with increased anti-tumor activity without adding significant risks of toxicity.The purpose of this study is to evaluate the efficacy and the safety of clofarabine in combination with IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or ALL not eligible to conventional or standard myeloablative allo-SCT.

ReferenceCitation: Chevallier P, Labopin M, Socié G, Tabrizi R, Furst S, Lioure B, Guillaume T, Delaunay J, de La Tour RP, Vigouroux S, El-Cheikh J, Blaise D, Michallet M, Bilger K, Milpied N, Moreau P, Mohty M. Results from a clofarabine-busulfan-containing, reduced-toxicity conditioning regimen prior to allogeneic stem cell transplantation: the phase 2 prospective CLORIC trial. Haematologica. 2014 Sep;99(9):1486-91. doi: 10.3324/haematol.2014.108563. Epub 2014 Jun 20.

family: Chevallier

full_name: P. Chevallier

family: Labopin

full_name: M. Labopin

family: Socie

full_name: G. Socie

given: G.

family: Tabrizi

full_name: R. Tabrizi

given: R.

family: Furst

full_name: S. Furst

given: S.

family: Lioure

full_name: B. Lioure

given: B.

family: Guillaume

full_name: T. Guillaume

given: T.

family: Delaunay

full_name: J. Delaunay

family: de La Tour

full_name: R. P. de La Tour

given: R. P.

family: Vigouroux

full_name: S. Vigouroux

family: El-Cheikh

full_name: J. El-Cheikh

family: Blaise

full_name: D. Blaise

given: D.

family: Michallet

full_name: M. Michallet

family: Bilger

full_name: K. Bilger

given: K.

family: Milpied

full_name: N. Milpied

given: N.

family: Moreau

full_name: P. Moreau

family: Mohty

full_name: M. Mohty

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

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

repository_normalized: HAL

publisher: Ferrata Storti Foundation (Haematologica)

location_facility:
Hôpital Edouard Herriot
Nantes University hospital
CHRU Hautepierre
Hôpital Saint Louis
CHU Haut-Lévêque
Institut Paoli Calmettes


title: Impact of a Fermented Infant Formula in Weaning Babies

summary: When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.

lead_sponsor: Bledina

location_facility:
Hôpital saint Vincent de Paul
Cabinet medical
Cabinet médical


title: Impact of the Hepatitis C Virus Variability on Liver Steatosis

acronym: Viro-steatosis

summary: Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend mainly on the importance of liver damage (fibrosis), which can be assessed by physical techniques, blood tests and a liver biopsy. The overall objectives of the project are to understand how HCV variability may influence the severity of steatosis (accumulation of fat in the liver), studying 30 patients chronically infected with HCV (half of these patients infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A small portion of the biopsy performed for the routine pathology examination will be placed in special fixation buffer for electron microscopy (EM). Counting and measuring the size of lipid droplets present in the liver by EM will be used to precisely quantify and characterize the liver steatosis. A blood sample of patients will also be collected to sequence the viral genome present in the patient and identify the amino acids involved in an increase in intracellular accumulation of lipid droplets. This work should clarify the impact of the viral variability in the severity of steatosis. Ultimately, the identification of viral sequences responsible for an increase of this phenomenon could be crucial for understanding the mechanisms involved in the steatosis.

lead_sponsor: University Hospital, Tours

location_facility:
CH de Châteauroux
CH de Dreux
CHR Orléans
CHRU de Tours
CH de Blois
CH de Bourges


ReferenceCitation: Ternant D, Ducourau E, Perdriger A, Corondan A, Le Goff B, Devauchelle-Pensec V, Solau-Gervais E, Watier H, Goupille P, Paintaud G, Mulleman D. Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis. Br J Clin Pharmacol. 2014 Jul;78(1):118-28. doi: 10.1111/bcp.12313.

name: Université François Rabelais de Tours; GICC; Tours France

family: Ternant

full_name: David Ternant

given: David

family: Ducourau

full_name: Emilie Ducourau

given: Emilie

family: Perdriger

full_name: Aleth Perdriger

given: Aleth

family: Corondan

full_name: Anca Corondan

given: Anca

family: Le Goff

full_name: Benoît Le Goff

given: Benoît

name: Université de Bretagne Occidentale; EA 2216; CHRU de Brest; Brest France

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

family: Solau-Gervais

full_name: Elisabeth Solau-Gervais

given: Elisabeth

family: Watier

full_name: Hervé Watier

given: Hervé

family: Goupille

full_name: Philippe Goupille

given: Philippe

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

family: Mulleman

full_name: Denis Mulleman

given: Denis

journal_name: British Journal of Clinical Pharmacology

evidence: open (via free article)

acronym: FAKIR

location_facility:
CHRU de Nantes
CHR d'Orléans
CHRU de Poitiers
CHRU de Tours
CHRU de Brest
CHRU de Rennes

title: Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab

summary:
Infliximab is a chimeric monoclonal antibody directed towards Tumor Necrosis Factor -alpha that is largely used in inflammatory diseases such as rheumatoid arthritis (RA).

A relationship between dose and clinical outcomes was shown in populations of RA patients but there is an interindividual variability of this relationship. At an individual level, this dose-effet relationship can be separated into the dose-concentration (pharmacokinetic or PK) and the concentration-effet (pharmacokinetic-pharmacodynamic or PK-PD) relationships.

Serum trough concentrations of infliximab have been shown to be variable between patients receiving the same treatment regimen. This PK variability may be explained by several factors (e.g. genetic and immunological factors). The concentration-effect relationship may also be variable and the sources of this variability need to be studied as well. To date no detailed infliximab PK analysis has been published. The sources of variability of the dose-effect relationship need to be characterized to optimize infliximab dosing regimen in patients.

The FAKIR study is a multicenter prospective observational study that will focus on patients treated with infliximab. Its aims are:

to characterize the PK and PK-PD variability of infliximab in RA, using clinical criteria and biomarkers, assessed over time ;
to study the influence of the polymorphism of FCGRT (the gene encoding FcRn) on the PK variability of infliximab; to study the influence of the polymorphism of FCGR3A (the gene encoding Fc gamma RIIIa) on the PK-PD variability of infliximab; and to study the influence of antibodies toward infliximab on the PK and PK-PD variabilities of infliximab.


title: Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication

summary: The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU Limoges
CHU de Dijon
CHU de Nice
University hospital of Bordeaux
CH Saint Pierre La Réunion
CHU Rennes


title: Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy in Patients With Uncertain Diagnosis Consulting for Clinical Symptoms Suggestive of Spondylarthropathy

acronym: EchoSpA

summary: The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis

ReferenceCitation: Devauchelle-Pensec V, D'Agostino MA, Marion J, Lapierre M, Jousse-Joulin S, Colin D, Chary-Valckenaere I, Marcelli C, Loeuille D, Aegerter P, Guis S, Gaudin P, Breban M, Saraux A; Study Group of Spondylarthritis. Computed tomography scanning facilitates the diagnosis of sacroiliitis in patients with suspected spondylarthritis: results of a prospective multicenter French cohort study. Arthritis Rheum. 2012 May;64(5):1412-9. doi: 10.1002/art.33466.

family: D'Agostino

full_name: Maria Antonietta D'Agostino

given: Maria Antonietta

family: Marion

full_name: Julien Marion

given: Julien

family: Lapierre

full_name: Marie Lapierre

given: Marie

family: Jousse-Joulin

full_name: Sandrine Jousse-Joulin

given: Sandrine

family: Colin

full_name: Danielle Colin

given: Danielle

family: Chary-Valckenaere

full_name: Isabelle Chary-Valckenaere

given: Isabelle

family: Marcelli

full_name: Christian Marcelli

given: Christian

family: Loeuille

full_name: Damien Loeuille

given: Damien

family: Aegerter

full_name: Philippe Aegerter

family: Guis

full_name: Sandrine Guis

family: Gaudin

full_name: Philippe Gaudin

family: Breban

full_name: Maxime Breban

given: Maxime

family: Saraux

full_name: Alain Saraux

given: Alain

journal_name: Arthritis & Rheumatism

title: Computed tomography scanning facilitates the diagnosis of sacroiliitis in patients with suspected spondylarthritis: Results of a prospective multicenter French cohort study

lead_sponsor: Dr Maria-Atonietta D'AGOSTINO

location_facility:
Ambroise Paré Hospital
Nancy Brabois Hospital
South Hospital of Grenoble
Conception Hospital
Cote de Nacre Hospital
Cavale Blanche Hospital


title: Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery: a Multicenter, Randomized, Double-blind, Comparative Study

acronym: EVOLUTION

summary: The purpose of this study is to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on respiratory-induced pulse pressure variation monitoring may improve outcome after intrabdominal surgery

location_facility: Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU


ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12:CD008500. doi: 10.1002/14651858.CD008500.pub5.

name: Institute of Social and Preventive Medicine (ISPM); University of Bern; Bern Switzerland

family: Rutjes

full_name: Anne WS Rutjes

given: Anne WS

name: Department of Medical, Oral and Biotechnological Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Italy

family: Porreca

full_name: Ettore Porreca

given: Ettore

name: Internal Medicine Unit; "University G. D'Annunzio" Foundation; Chieti Italy

family: Candeloro

full_name: Matteo Candeloro

given: Matteo

family: Valeriani

full_name: Emanuele Valeriani

given: Emanuele

name: Department of Medicine and Ageing Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Scalo Italy

name: Department of Vascular Medicine; Academic Medical Center; Amsterdam Netherlands

family: Di Nisio

full_name: Marcello Di Nisio

given: Marcello

oa_host_type: repository

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

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

title: Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer.

PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.


ReferenceCitation: Lerebours F, Rivera S, Mouret-Reynier MA, Alran S, Venat-Bouvet L, Kerbrat P, Salmon R, Becette V, Bourgier C, Cherel P, Boussion V, Balleyguier C, Thibault F, Lavau-Denes S, Nabholz JM, Sigal B, Trassard M, Mathieu MC, Martin AL, Lemonnier J, Mouret-Fourme E. Randomized phase 2 neoadjuvant trial evaluating anastrozole and fulvestrant efficacy for postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients: Results of the UNICANCER CARMINA 02 French trial (UCBG 0609). Cancer. 2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143. Epub 2016 Jun 17.

family: Lerebours

full_name: Florence Lerebours

given: Florence

name: Gustave Roussy Institute; Villejuif France

family: Rivera

full_name: Sofia Rivera

given: Sofia

name: Jean Perrin Center; Clermont Ferrand France

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

given: Marie-Ange

family: Alran

full_name: Severine Alran

given: Severine

name: Hospital and University Center; Limoges France

family: Venat-Bouvet

full_name: Laurence Venat-Bouvet

given: Laurence

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Salmon

full_name: Remy Salmon

given: Remy

family: Becette

full_name: Veronique Becette

given: Veronique

family: Bourgier

full_name: Céline Bourgier

given: Céline

family: Cherel

full_name: Pascal Cherel

given: Pascal

family: Boussion

full_name: Véronique Boussion

given: Véronique

family: Balleyguier

full_name: Corinne Balleyguier

given: Corinne

family: Thibault

full_name: Fabienne Thibault

given: Fabienne

family: Lavau-Denes

full_name: Sandrine Lavau-Denes

family: Nabholz

full_name: Jean-Marc Nabholz

given: Jean-Marc

family: Sigal

full_name: Brigitte Sigal

given: Brigitte

family: Trassard

full_name: Martine Trassard

given: Martine

family: Mathieu

full_name: Marie-Christine Mathieu

given: Marie-Christine

family: Martin

full_name: Anne-Laure Martin

given: Anne-Laure

family: Lemonnier

full_name: Jerome Lemonnier

given: Jerome

family: Mouret-Fourme

full_name: Emmanuelle Mouret-Fourme

given: Emmanuelle

journal_name: Cancer

ReferenceCitation: Lerebours F, Pulido M, Fourme E, Debled M, Becette V, Bonnefoi H, Rivera S, MacGrogan G, Mouret-Reynier MA, de Lara CT, Pierga JY, Breton-Callu C, Venat-Bouvet L, Mathoulin-Pélissier S, de la Motte Rouge T, Dalenc F, Sigal B, Bachelot T, Lemonnier J, Quenel-Tueux N. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials. Br J Cancer. 2020 Mar;122(6):759-765. doi: 10.1038/s41416-020-0733-x. Epub 2020 Jan 31.

ReferenceCitation: Liang X, Briaux A, Becette V, Benoist C, Boulai A, Chemlali W, Schnitzler A, Baulande S, Rivera S, Mouret-Reynier MA, Bouvet LV, De La Motte Rouge T, Lemonnier J, Lerebours F, Callens C. Molecular profiling of hormone receptor-positive, HER2-negative breast cancers from patients treated with neoadjuvant endocrine therapy in the CARMINA 02 trial (UCBG-0609). J Hematol Oncol. 2018 Oct 11;11(1):124. doi: 10.1186/s13045-018-0670-9.

location_facility:
Institut Curie Hopital
Centre Eugene Marquis
Centre Jean Perrin
Centre Rene Huguenin
Hopital Dupuytren
Institut Gustave Roussy

title: A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.


title: Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study.

summary: The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".

ReferenceCitation: Nabholtz JM, Chalabi N, Radosevic-Robin N, Dauplat MM, Mouret-Reynier MA, Van Praagh I, Servent V, Jacquin JP, Benmammar KE, Kullab S, Bahadoor MR, Kwiatkowski F, Cayre A, Abrial C, Durando X, Bignon YJ, Chollet P, Penault-Llorca F. Multicentric neoadjuvant pilot Phase II study of cetuximab combined with docetaxel in operable triple negative breast cancer. Int J Cancer. 2016 May 1;138(9):2274-80. doi: 10.1002/ijc.29952. Epub 2015 Dec 28.

name: ERTICA EA 4677, University of Auvergne; Clermont-Ferrand France

name: Clinical and Translational Research Division; Jean Perrin Comprehensive Cancer Centre; Clermont-Ferrand France

name: CIC 501, UMR 766; Clermont-Ferrand France

name: Medical Oncology; Jean Perrin Comprehensive Cancer Centre; Clermont-Ferrand France

family: Nabholtz

full_name: J.M. Nabholtz

family: Chalabi

full_name: N. Chalabi

given: N.

name: Department of Biopathology; Jean Perrin Comprehensive Cancer Centre; Clermont-Ferrand France

family: Radosevic-Robin

full_name: N. Radosevic-Robin

family: Dauplat

full_name: M.M. Dauplat

family: Mouret-Reynier

full_name: M.A. Mouret-Reynier

family: Van Praagh

full_name: I. Van Praagh

given: I.

name: Oscar Lambret Comprehensive Cancer Centre; Lille France

family: Servent

full_name: V. Servent

given: V.

name: Lucien Neuwirth Institute; Saint-Etienne France

family: Jacquin

full_name: JP Jacquin

given: JP

family: Benmammar

full_name: K.E. Benmammar

family: Kullab

full_name: S. Kullab

given: S.

name: Oncauvergne Regional Oncology Network, Jean Perrin Comprehensive Cancer Centre; Clermont-Ferrand France

family: Bahadoor

full_name: M.R.K. Bahadoor

name: LMB GenAuvergne Oncogenetics Department; Jean Perrin Comprehensive Cancer Centre; Clermont-Ferrand France

family: Kwiatkowski

full_name: F. Kwiatkowski

given: F.

family: Cayre

full_name: A. Cayre

given: A.

family: Abrial

full_name: C. Abrial

given: C.

name: EA 3846, University of Auvergne; Clermont-Ferrand France

family: Durando

full_name: X. Durando

given: X.

family: Bignon

full_name: Y.J. Bignon

name: University of Auvergne Clermont-Ferrand; Clermont-Ferrand France

family: Chollet

full_name: P. Chollet

given: P.

family: Penault-Llorca

full_name: F. Penault-Llorca

journal_name: International Journal of Cancer

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Oscar Lambret
Centre Hospitalier
Centre Jean Perrin
Hôpital Georges Pianta
Institut de Cancérologie de la LOIRE
CHU Albert Michallon


title: Open-label, Dose-escalating, Phase I Study of TG4040 (MVA-HCV) in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus (HCV Genotype 1)

summary:
The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040 in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).

Patients will be sequentially treated at an escalting dose of TG4040. All patients will be followed up to at least 6 months after his/her first injection. In addition, all patients treated at the highest dose will receive a TG4040 boost injection 6 months after the first injection, and will be followed up during an additional 6-month period.

ReferenceCitation: Habersetzer F, Honnet G, Bain C, Maynard-Muet M, Leroy V, Zarski JP, Feray C, Baumert TF, Bronowicki JP, Doffoël M, Trépo C, Agathon D, Toh ML, Baudin M, Bonnefoy JY, Limacher JM, Inchauspé G. A poxvirus vaccine is safe, induces T-cell responses, and decreases viral load in patients with chronic hepatitis C. Gastroenterology. 2011 Sep;141(3):890-899.e1-4. doi: 10.1053/j.gastro.2011.06.009. Epub 2011 Jun 13.

family: Habersetzer

full_name: François Habersetzer

given: François

family: Honnet

full_name: Géraldine Honnet

given: Géraldine

family: Bain

full_name: Christine Bain

given: Christine

family: Maynard–Muet

full_name: Marianne Maynard–Muet

given: Marianne

family: Leroy

full_name: Vincent Leroy

given: Vincent

family: Zarski

full_name: Jean–Pierre Zarski

given: Jean–Pierre

family: Feray

full_name: Cyrille Feray

given: Cyrille

family: Baumert

full_name: Thomas F. Baumert

given: Thomas F.

family: Bronowicki

full_name: Jean–Pierre Bronowicki

family: Doffoël

full_name: Michel Doffoël

given: Michel

family: Trépo

full_name: Christian Trépo

given: Christian

family: Agathon

full_name: Delphine Agathon

given: Delphine

family: Toh

full_name: Myew–Ling Toh

given: Myew–Ling

family: Baudin

full_name: Martine Baudin

family: Bonnefoy

full_name: Jean–Yves Bonnefoy

given: Jean–Yves

family: Limacher

full_name: Jean–Marc Limacher

given: Jean–Marc

family: Inchauspé

full_name: Geneviève Inchauspé

given: Geneviève

bso_classification: Biology (fond.)

journal_name: Gastroenterology

title: A Poxvirus Vaccine Is Safe, Induces T-Cell Responses, and Decreases Viral Load in Patients With Chronic Hepatitis C

location_facility:
Hôpital de l'Hôtel Dieu
Hopital de l'Hotel-Dieu
Hôpital Henri Mondor
Hopital A. Michallon
Hôpital de Brabois
Hopital Civil


title: Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

summary:
This is a prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC).

There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies of vaginal flora are a potential target for the campaign against prematurity.

The main objective of this study is to achieve an objective and reproducible technique of identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies.

The secondary objectives are the exhaustive culture of bacteria, the characterisation of intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the ribosomic ADN 16S coupled with clonage techniques.

The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).

ReferenceCitation: Bretelle F, Rozenberg P, Pascal A, Favre R, Bohec C, Loundou A, Senat MV, Aissi G, Lesavre N, Brunet J, Heckenroth H, Luton D, Raoult D, Fenollar F; Groupe de Recherche en Obstetrique Gynecologie. High Atopobium vaginae and Gardnerella vaginalis vaginal loads are associated with preterm birth. Clin Infect Dis. 2015 Mar 15;60(6):860-7. doi: 10.1093/cid/ciu966. Epub 2014 Dec 1.

name: Department of Gynecology and Obstetrics, Gynépole, Marseille, Pr Boubli et D'Ercole, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, AMU, Aix-Marseille Université

name: Aix-Marseille Université, Unité de Recherche sur les Maladies Infectieuses Tropicales et Emergentes, UM63, CNRS 7278, IRD 198, INSERM 1095, Marseille

family: Bretelle

full_name: Florence Bretelle

given: Florence

name: Department d'obstétrique et gynécologie, Centre Hospitalier Poissy Saint-Germain en Laye

family: Rozenberg

full_name: Patrick Rozenberg

given: Patrick

name: Service de Gynecologie Obstétrique Hôpital Fondation Saint Joseph Marseille

family: Pascal

full_name: Alain Pascal

given: Alain

name: Service de Gynecologie Obstétrique du CMCO-HUS, Schiltigheim/Strasbourg

family: Favre

full_name: Romain Favre

given: Romain

name: Service de Gynécologie-Obstétrique, CIC, CHU Brest, Hôpital Morvan, CH de Pau

family: Bohec

full_name: Caroline Bohec

given: Caroline

name: Medical Evaluation, Department of Public Health, Assistance Publique-Hôpitaux de Marseille, AMU, Aix-Marseille Université

family: Loundou

full_name: Anderson Loundou

given: Anderson

name: Hôpital Antoine Béclère et Kremlin-Bicêtre, Department de Gynécologie-Obstétrique, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpital Bicêtre, Université Paris Sud, Faculté de Medecine, Orsay

family: Senat

full_name: Marie-Victoire Senat

given: Marie-Victoire

family: Aissi

full_name: Germain Aissi

given: Germain

name: Centre d'investigation Clinique, Aix-Marseille Université, AP-HM, AMU, Marseille

family: Lesavre

full_name: Nathalie Lesavre

given: Nathalie

family: Brunet

full_name: Julie Brunet

given: Julie

family: Heckenroth

full_name: Hélène Heckenroth

given: Hélène

name: Hôpitaux Paris Sud, Hôpital Beaujon, Department of Obstetrics and Gynecology, Hôpital Bichat Beaujon, AP-HP, Université Paris VII Denis Diderot, France

family: Luton

full_name: Dominique Luton

given: Dominique

family: Raoult

full_name: Didier Raoult

given: Didier

family: Fenollar

full_name: Florence Fenollar

family: Cocallemen

full_name: Jean-Francois Cocallemen

given: Jean-Francois

family: Henry-Mary

full_name: Mireille Henry-Mary

given: Mireille

family: Boubli

full_name: Léon Boubli

given: Léon

family: D'ercole

full_name: Claude D'ercole

given: Claude

family: Chau

full_name: Cécile Chau

given: Cécile

family: Piechon

full_name: Laurence Piechon

given: Laurence

family: Zarka

full_name: Valérie Zarka

given: Valérie

family: Desbriere

full_name: Raoul Desbriere

given: Raoul

family: Shojai

full_name: Raha Shojai

given: Raha

family: Puppo

full_name: Séverine Puppo

name: for the Groupe de Recherche en Obstetrique Gynecologie

title: High Atopobium vaginae and Gardnerella vaginalis Vaginal Loads Are Associated With Preterm Birth

ReferenceCitation: Menard JP, Fenollar F, Raoult D, Boubli L, Bretelle F. Self-collected vaginal swabs for the quantitative real-time polymerase chain reaction assay of Atopobium vaginae and Gardnerella vaginalis and the diagnosis of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):513-8. doi: 10.1007/s10096-011-1341-8. Epub 2011 Jul 26.

journal_name: European Journal of Clinical Microbiology & Infectious Diseases

ReferenceCitation: Menard JP, Mazouni C, Salem-Cherif I, Fenollar F, Raoult D, Boubli L, Gamerre M, Bretelle F. High vaginal concentrations of Atopobium vaginae and Gardnerella vaginalis in women undergoing preterm labor. Obstet Gynecol. 2010 Jan;115(1):134-140. doi: 10.1097/AOG.0b013e3181c391d7.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: High Vaginal Concentrations of Atopobium vaginae and Gardnerella vaginalis in Women Undergoing Preterm Labor

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
CHU Antoine BECLERE
Centre Hospitalier Poissy-Saint-Germain
Centre médicochirurgical et obstétrical
Hôpital de la Conception
Hôpital Nord-OB/GYN Department
Hôpital Saint Joseph


title: Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response

summary:
Neoadjuvant chemotherapy, known as "first" or "induction chemotherapy" in the therapeutic assumption of breast cancer is based on the narrow dependence preclinically revealed between primary tumour, tumoral angiogenesis and growth of distant metastases.

The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have shown that a sequential protocol, using docetaxel after an anthracycline-based combination, allowed a better clinical response leading to more frequent conservative surgeries and, more importantly, to an increase in the rate of complete pathological response, assessing a better efficacy.

The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and the same chemotherapy given as an induction treatment Even keeping the principle of a sequential treatment, a crucial question is to know if this sequential treatment should be the same for all patients, or if the oncologist could get a better complete pathological response, disease-free or overall survival rates by an adaptation of treatment to the objective result beginning after 2 FEC 100 courses by modulation of the following courses.

We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie -- volume 7 - N°5, August 2005, p 370). This standard treatment will be compared to the same chemotherapy modulated in its repartition according to results obtained by subsequent tumor evaluations during induction therapy.

ReferenceCitation: Roché H, Fumoleau P, Spielman M et al. Breast Cancer Res Treat. 2004;88(suppl1):S16. Abstract 27

ReferenceCitation: Mouret-Reynier MA, Abrial CJ, Ferrière JP, Amat S, Curé HD, Kwiatkowski FG, Feillel VA, Lebouëdec G, Penault-Llorca FM, Chollet PJ. Neoadjuvant FEC 100 for operable breast cancer: eight-year experience at Centre Jean Perrin. Clin Breast Cancer. 2004 Oct;5(4):303-7.

ReferenceCitation: Wang-Lopez Q, Mouret-Reynier MA, Savoye AM, Abrial C, Kwiatkowski F, Garbar C, DuBray-Longeras P, Eymard JC, Lebouedec G, Vanpraagh I, Penault-Llorca F, Chollet P, Cure H. Is it important to adapt neoadjuvant chemotherapy to the visible clinical response? An open randomized phase II study comparing response-guided and standard treatments in HER2-negative operable breast cancer. Oncologist. 2015 Mar;20(3):243-4. doi: 10.1634/theoncologist.2014-0400. Epub 2015 Jan 30.

name: Centre Jean Perrin, Clermont‐Ferrand, France;

name: Clinical Investigation Center (CIC), Clermont‐Ferrand, France;

family: Wang‐Lopez

full_name: Qian Wang‐Lopez

given: Qian

family: Mouret‐Reynier

full_name: Marie‐Ange Mouret‐Reynier

given: Marie‐Ange

family: Savoye

full_name: Aude‐Marie Savoye

given: Aude‐Marie

name: ERTICA EA 4677, Research Team for Individualized Cancer Treatment, and

family: Abrial

full_name: Catherine Abrial

given: Catherine

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

family: Garbar

full_name: Christian Garbar

given: Christian

family: DuBray‐Longeras

full_name: Pascale DuBray‐Longeras

given: Pascale

family: Eymard

full_name: Jean‐Christophe Eymard

given: Jean‐Christophe

family: Lebouedec

full_name: Guillaume Lebouedec

given: Guillaume

family: Vanpraagh

full_name: Isabelle Vanpraagh

given: Isabelle

family: Penault‐Llorca

full_name: Frederique Penault‐Llorca

given: Frederique

name: UMR 990 INSERM, University of Auvergne, Clermont‐Ferrand, France

family: Chollet

full_name: Philippe Chollet

given: Philippe

family: Cure

full_name: Hervé Cure

given: Hervé

journal_name: The Oncologist

title: Is It Important to Adapt Neoadjuvant Chemotherapy to the Visible Clinical Response? An Open Randomized Phase II Study Comparing Response‐Guided and Standard Treatments in HER2‐Negative Operable Breast Cancer

location_facility:
Edouard Herriot University Hospital
Hospital center
Centre Jean Perrin
Institut Jean Godinot
University Hospital La Tronche
Institut de Cancérologie de la Loire


title: Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion

summary: To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

ReferenceCitation: Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9.

lead_sponsor: Hopital Foch

location_facility: Dept of Anesthesia and Intensive Care, Hôpital Beaujon

location_facility: Dept of Anesthesia, Clinique Saint Augustin


title: A Network to Control Risk Factors After Acute Coronary Syndrome

summary: The purpose of this study is to determine whether the follow up of patients with acute coronary syndrome and modifiable cardiovascular risk factors is efficient based on outpatients visits in a House of Education, underlining the importance of nicotinic weaning, weight loss and physical activity practice.

ReferenceCitation: Cohen A, Assyag P, Boyer-Chatenet L, Cohen-Solal A, Perdrix C, Dalichampt M, Michel PL, Montalescot G, Ravaud P, Steg PG, Boutron I; Réseau Insuffisance Cardiaque (RESICARD) PREVENTION Investigators. An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):40-8. doi: 10.1001/jamainternmed.2013.11342.

name: Service de Cardiologie, Hôpital Saint-Antoine, Assistance Publique des Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France

family: Cohen

full_name: Ariel Cohen

given: Ariel

name: currently in private practice, Paris, France

family: Assyag

full_name: Patrick Assyag

given: Patrick

family: Boyer-Chatenet

full_name: Louise Boyer-Chatenet

given: Louise

name: Service de Cardiologie, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale Unité 738, Paris, France

family: Cohen-Solal

full_name: Alain Cohen-Solal

given: Alain

name: Service de Cardiologie, Hôpital La Roseraie, Aubervilliers, France

family: Perdrix

full_name: Christel Perdrix

given: Christel

family: Dalichampt

full_name: Marie Dalichampt

given: Marie

name: Institut Cardiologie, Hôpital Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris, Université Paris 6 (Université Pierre et Marie Curie), Institut National de la Santé et de la Récherche Médicale Commission Médicale Régionale 937, Paris, France

family: Michel

full_name: Pierre-Louis Michel

given: Pierre-Louis

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

name: Centre d’Epidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France7Institut National de la Santé et de la Recherche Médicale Unité 738, Paris, France8Faculté de Médecine, Université Paris Descartes, Sorbonne Pari

family: Ravaud

full_name: Philippe Ravaud

name: Département Hospitalo-Universitaire Fibrosis-Inflammation-Remodeling (FIRE), Hôpital Bichat, Assistance Publique des Hôpitaux de Paris, Paris, France10Service de Cardiologie, Institut National de la Santé et de la Recherche Médicale INSERM Unité 698, Univ

family: Steg

full_name: P. Gabriel Steg

given: P. Gabriel

family: Boutron

full_name: Isabelle Boutron

journal_name: JAMA Internal Medicine

title: An Education Program for Risk Factor Management After an Acute Coronary Syndrome

lead_sponsor: Resicard

location_facility:
Hopital Bichat
Hopital Saint Antoine
Hopital Lariboisiere
Hopital Pitie Salpetriere
Clinique la Roseraie
Hopital Tenon


title: A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy

summary: The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.

lead_sponsor: Bristol-Myers Squibb


title: Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy With Cisplatin-docetaxel in Patients With Locally Advanced Non-small-cell Lung Cancer. A Multicenter Phase II Trial

acronym: VINCR

summary:
Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous form because: 1- Previous investigations have demonstrated that oral vinorelbine is as effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of oral agents in CT will reduce some disagreements provoked by intravenous injections: stress, infections, hemorrhage, displacement at the hospital and cost of CT.

.

ReferenceCitation: Fournel P, Robinet G, Thomas P, Souquet PJ, Léna H, Vergnenégre A, Delhoume JY, Le Treut J, Silvani JA, Dansin E, Bozonnat MC, Daurés JP, Mornex F, Pérol M; Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Français de Pneumo-Cancérologie. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Français de Pneumo-Cancérologie NPC 95-01 Study. J Clin Oncol. 2005 Sep 1;23(25):5910-7. Epub 2005 Aug 8.

ReferenceCitation: Vergnenègre A, Daniel C, Léna H, Fournel P, Kleisbauer JP, Le Caer H, Letreut J, Paillotin D, Pérol M, Bouchaert E, Preux PM, Robinet G; Groupe Francais de Pneumo-Cancerologie. Docetaxel and concurrent radiotherapy after two cycles of induction chemotherapy with cisplatin and vinorelbine in patients with locally advanced non-small-cell lung cancer. A phase II trial conducted by the Groupe Francais de Pneumo-Cancerologie (GFPC). Lung Cancer. 2005 Mar;47(3):395-404.

lead_sponsor: University Hospital, Brest

location_facility:
CH GAP
CHU Hôpital Nord
Hopital de la Croix Rousse
CHU of Brest
Hôpital Sainte Margueritte
CHU de LIMOGES


title: Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin

summary:
RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.

PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.

status: Unknown status

location_facility: Centre Hospital Universitaire Hop Huriez


title: Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.

summary:
Primary Objective:

To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.

Secondary Objectives:

To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.

lead_sponsor: Sanofi


title: A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma

summary: A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.

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 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician


title: Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.

summary:
Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves a fat mass increase with regard to lean mass, an atherogenic lipidic profile and participating to osteopenia mechanism and decrease the life quality. All these dysfunctions are partially or totally corrected by the GH prescription with patient deficient since adulthood.

However, for patients deficient since childhood, no study have demonstrated that GH treatment during childhood present these same benefit when they are treated during adulthood.

Primary objective of this study is to examine that fat mass significantly decrease due to GH treatment in adulthood for patient GH deficient since childhood, treated by GH during childhood but stopped since the end of adolescence.

We compare the body composition and others energetic metabolism parameters in two patient groups, one treated by GH during 18 months, and the other with no treatment. Body composition and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly labelled water) and biologic parameters (lipidic profile, thyroid hormones).

This study will evaluate if the GH treatment of young GH deficient adults since childhood can be a benefit for body composition, lipidic profile and bone density.

lead_sponsor: University Hospital, Angers

location_facility:
UH of Angers
UH of Brest
UH of Limoges
UH of Caen
UH of Tours
UH of Rennes


title: Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.

location_facility:
Polyclinique De Courlancy
Centre Medico-Chirurgical Foch
C.H. Senlis
Hopital Saint Antoine
Centre Hospitalier Victor Dupouy
Hopital Tenon


title: Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer.

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Thromboembolic Risk Screening in Patients With Cancer and COVID-19

acronym: NEOTHROCOVID

summary:
Study Rational

Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19.

High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19.

Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment.

Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01).

However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients.

The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE.

The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation.

The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer.

Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient.

For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE.

Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test.

Methodology

Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection.

Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE.

Trial objectives

Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.

status: Recruiting

primary_purpose: Screening

lead_sponsor: Centre Antoine Lacassagne

location_country: Monaco France

location_facility:
Clinique Saint-Georges
Centre Antoine Lacassagne
Centre Azuréen de Cancérologie
Clinique Saint-Jean
CHPG
CHU Nice

intervention_type: Diagnostic Test


title: Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.

acronym: CRT-MPP

summary: The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy

study_start_date_type: Anticipated

status: Withdrawn

primary_purpose: Other

lead_sponsor: CMC Ambroise Paré

location_facility:
Centre Hospitalier Princesse Grace
PHc hôpital d'Antibes la Fontonne
CMC Ambroise Paré
Centre Hospitalier de Perpignan
CHU Nice
Centre hospitalier de Cannes


title: A 3-month Randomized Double Blind Placebo-controlled Multicenter Study to Assess the Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome

summary: The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption.

lead_sponsor: LNC THERAPEUTICS

location_country: Ireland France

location_facility:
Eurofins Optimed
CEN Experimental
Institut Pasteur de Lille
CIC Pitié Salpêtrière
Biofortis
Atlantia Food Clinical Trials

intervention_type: Dietary Supplement


title: Randomized Phase III Study Comparing an Adjuvant Chemotherapy With Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma

acronym: FOTEADJ

summary:
After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external radiotherapy) patients with high risk of metastasis are randomized between:

Adjuvant chemotherapy with Fotemustin.
Observation

Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.

lead_sponsor: Institut Curie

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois


title: INTERNATIONAL STUDY of Chronic Myeloid Leukaemia (CML) Treatment and Outcomes in Children and Adolescents

acronym: ICMLPed

summary: The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.

ReferenceCitation: Meyran D, Petit A, Guilhot J, Suttorp M, Sedlacek P, De Bont E, Li CK, Kalwak K, Lausen B, Culic S, de Moerloose B, Biondi A, Millot F. Lymphoblastic predominance of blastic phase in children with chronic myeloid leukaemia treated with imatinib: A report from the I-CML-Ped Study. Eur J Cancer. 2020 Sep;137:224-234. doi: 10.1016/j.ejca.2020.06.024. Epub 2020 Aug 13.

family: Meyran

full_name: Deborah Meyran

given: Deborah

family: Petit

full_name: Arnaud Petit

given: Arnaud

family: Guilhot

full_name: Joelle Guilhot

given: Joelle

family: Suttorp

full_name: Meinolf Suttorp

given: Meinolf

family: Sedlacek

full_name: Petr Sedlacek

given: Petr

family: De Bont

full_name: Eveline De Bont

given: Eveline

family: Li

full_name: Chi Kong Li

given: Chi Kong

family: Kalwak

full_name: Krzysztof Kalwak

given: Krzysztof

family: Lausen

full_name: Birgitte Lausen

given: Birgitte

family: Culic

full_name: Srdjana Culic

given: Srdjana

family: de Moerloose

full_name: Barbara de Moerloose

given: Barbara

family: Biondi

full_name: Andrea Biondi

given: Andrea

family: Millot

full_name: Frédéric Millot

given: Frédéric

journal_name: European Journal of Cancer

ReferenceCitation: Millot F, Maledon N, Guilhot J, Güneş AM, Kalwak K, Suttorp M. Favourable outcome of de novo advanced phases of childhood chronic myeloid leukaemia. Eur J Cancer. 2019 Jul;115:17-23. doi: 10.1016/j.ejca.2019.03.020. Epub 2019 May 10.

family: Maledon

full_name: Natacha Maledon

given: Natacha

family: Güneş

full_name: Adalet Meral Güneş

given: Adalet Meral

ReferenceCitation: Millot F, Guilhot J, Suttorp M, Güneş AM, Sedlacek P, De Bont E, Li CK, Kalwak K, Lausen B, Culic S, Dworzak M, Kaiserova E, De Moerloose B, Roula F, Biondi A, Baruchel A. Prognostic discrimination based on the EUTOS long-term survival score within the International Registry for Chronic Myeloid Leukemia in children and adolescents. Haematologica. 2017 Oct;102(10):1704-1708. doi: 10.3324/haematol.2017.170035. Epub 2017 Aug 24.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Università degli Studi di Milano - Institutional Research Information System

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_country: Austria Brazil Chile Lebanon Netherlands Germany Croatia Czechia France Greece Japan Poland Slovakia Argentina Australia Belgium Belarus Turkey Denmark China

location_facility: Saint George Hospital University Medical Centre

location_facility: National Research Center for Pediatric Oncology and Hematology


type: Other Grant/Funding Number

title: Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex

acronym: EPISTOP

summary:
The primary objective of clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC.

Secondary objective of the clinical part of EPISTOP is to compare the effects of standard antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.

ReferenceCitation: van der Poest Clement E, Jansen FE, Braun KPJ, Peters JM. Update on Drug Management of Refractory Epilepsy in Tuberous Sclerosis Complex. Paediatr Drugs. 2020 Feb;22(1):73-84. doi: 10.1007/s40272-019-00376-0. Review.

family: van der Poest Clement

full_name: Emma van der Poest Clement

given: Emma

family: Jansen

full_name: Floor E. Jansen

given: Floor E.

family: Braun

full_name: Kees P. J. Braun

given: Kees P. J.

family: Peters

full_name: Jurriaan M. Peters

given: Jurriaan M.

journal_name: Pediatric Drugs

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Sergiusz Jozwiak

location_country:
Italy
Austria
Netherlands
France
Poland
Belgium
Germany
Czech Republic

location_facility: Institut National De La Sante et de la Recherche Medicale

location_facility: Universita Degli Studi Di Roma Tor Vergata


title: Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)

acronym: Exception

summary: This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

time_perspective: Other

lead_sponsor: Zimmer Biomet

location_country: Belgium France

location_facility:
CH Annecy Genevois
Hôpital Princesse Paola
Hopital Renee Sabran
Hôpitaux Du Léman
Clinique Basseres Kacem-Boudhar
CH Alpes Léman


title: An Open-label Phase I Dose Finding Study of BI 765063, a Monoclonal Antibody (mAb) Antagonist of SIRPα, as Single Agent and in Combination With BI 754091, a Programmed Death-1 (PD-1) mAb, to Characterize Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumours

summary: This trial will be a two steps Phase I clinical study in patients with advanced solid tumors with an escalating phase (Step 1) followed by an expansion phase (Step 2) of BI 765063, a monoclonal antibody (mAb) antagonist to signal regulatory protein alpha (SIRPα) receptor, a myeloid checkpoint inhibitor administered as single agent, and in combination with BI 754091, a mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor.

ipd_sharing: Undecided

lead_sponsor: OSE Immunotherapeutics

location_facility:
Centre Léon Berard
Centre Oscar Lambret
Institut Claudius Regaud
Institut Jules Bordet
Institut Gustave Roussy
Institut Bergonie


title: Intérêt de la règle CARE Pour Exclure l'hypothèse d'un Syndrome Coronarien Aigu Sans Dosage Biologique - ICARE

acronym: ICARE

summary:
Acute coronary syndrome (ACS) is a major health problem and its diagnosis remains a challenge for the emergency physician. The management of a suspected ACS is well codified, based on troponin assays, renewed if necessary.

Conversely, the criteria leading to initiate a diagnostic procedure in chest pain to the Emergency department are unclear. The fear is, firstly, to miss a potentially life treating diagnosis and, secondly, exposing many patients to unnecessary examinations. The advent of highly sensitive troponin assays also increases the risk of over-investigation by a larger number of elevations of the biomarker in non-coronary circumstances leading to a prolongation of hospitalization and, possibly, unnecessary treatments and invasive investigations.

CARE rule could help to streamline this first step. It is established by assigning a value from 0 to 2 to the items: Characteristic of pain, Age, Risk factors and ECG. The search for an ACS is not justified if the sum of points is ≤1 (negative rule) and, conversely, a troponin should be performed if the sum is > 1 (positive rule).

Indeed, CARE rule corresponds to the first 4 items of the HEART score (the latter standing for troponin at admission) whose reliability has been demonstrated, a ≤3 income excluding ACS with a risk of false negatives <2%. A negative CARE rule always corresponds to a HEART score ≤3.

Our study aims to confirm the interest of CARE rule to streamline the search for an ACS in chest pain as an observational European multicenter prospective study.

ReferenceCitation: Moumneh T, Penaloza A, Cismas A, Charpentier S, Schotté T, Pernet S, Malatest S, Prunier F, Warnant A, Mezdad TH, Gangloff C, Soulat L, Douillet D, Riou J, Roy PM. Evaluation of HEAR score to rule-out major adverse cardiac events without troponin test in patients presenting to the emergency department with chest pain. Eur J Emerg Med. 2021 Aug 1;28(4):292-298. doi: 10.1097/MEJ.0000000000000791.

family: Moumneh

full_name: Thomas Moumneh

given: Thomas

family: Penaloza

full_name: Andrea Penaloza

family: Cismas

full_name: Anda Cismas

given: Anda

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

family: Schotté

full_name: Thibault Schotté

given: Thibault

family: Pernet

full_name: Sabrina Pernet

given: Sabrina

family: Malatest

full_name: Stéphanie Malatest

given: Stéphanie

family: Prunier

full_name: Fabrice Prunier

given: Fabrice

family: Warnant

full_name: Alexandra Warnant

given: Alexandra

family: Mezdad

full_name: Tin-Hinan Mezdad

given: Tin-Hinan

family: Gangloff

full_name: Cédric Gangloff

given: Cédric

family: Soulat

full_name: Louis Soulat

given: Louis

family: Douillet

full_name: Delphine Douillet

given: Delphine

family: Riou

full_name: Jérémie Riou

given: Jérémie

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

journal_name: European Journal of Emergency Medicine

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

location_facility:
University Hospital Angers
Cliniques Universitaires Saint-Luc
Hospital of Saint-Malo
University Hospital Toulouse
SCHOTTE Thibault
Hospital of Cholet


title: A Proof of Concept Study to Investigate the Effect of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain or Osteoarthritic Pain of Knee or Hip

summary: The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response

primary_purpose: Basic Science

location_facility: CIC Clermont-Ferrand, CHU Clermont-Ferrand

location_facility: Centre d'Evaluation et Traitement de la Douleur, CHU Saint-Etienne


ReferenceCitation: Ofori-Anyinam O, Leroux-Roels G, Drame M, Aerssens A, Maes C, Amanullah A, Schuind A, Li P, Jain VK, Innis BL. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults ≥50years of age: Results from a phase III, randomized, non-inferiority trial. Vaccine. 2017 Nov 1;35(46):6321-6328. doi: 10.1016/j.vaccine.2017.09.012. Epub 2017 Oct 5.

family: Ofori-Anyinam

full_name: Opokua Ofori-Anyinam

given: Opokua

family: Leroux-Roels

full_name: Geert Leroux-Roels

given: Geert

family: Drame

full_name: Mamadou Drame

given: Mamadou

family: Aerssens

full_name: Annelies Aerssens

given: Annelies

family: Maes

full_name: Cathy Maes

given: Cathy

family: Amanullah

full_name: Arshad Amanullah

given: Arshad

family: Schuind

full_name: Anne Schuind

given: Anne

family: Li

full_name: Ping Li

given: Ping

family: Jain

full_name: Varsha K. Jain

given: Varsha K.

family: Innis

full_name: Bruce L. Innis

given: Bruce L.

title: Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults ≥50 years of age: Results from a phase III, randomized, non-inferiority trial

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

acronym: FLU D-QIV-010 PRI

ipd_sharing: Yes

title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older

summary: The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections.


title: Cross-validation of the Finger Prick Dried Blood Spot Assay Method With the Established Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

summary: The principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick DBS (Dry Blood Spot) method and those determined from blood samples collected by venepuncture in transplant recipients.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
United Kingdom
France

location_facility:
Site: 5
Site: 6
Site: 3
Site: 2
Site: 7
Site: 1


summary: This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.

lead_sponsor: Genzyme, a Sanofi Company

location_country: Germany France

location_facility: Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin

location_facility: Centre de Medecine et Traumatologie du Sport Clinique du Sport


title: A Phase II Randomized, Blinded, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Different Regimens of 1592U89 Monotherapy Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy-Naive Patients

summary: The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and effective in lowering viral load (level of HIV in the blood) and raising the level of CD4 cells (cells of the body that help fight infection).

ReferenceCitation: Staszewski S, Katlama C, Harrer T, Massip P, Yeni P, Cutrell A, Tortell SM, Harrigan RP, Steel H, Lanier RE, Pearce G. A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects. AIDS. 1998 Nov 12;12(16):F197-202.

lead_sponsor: Glaxo Wellcome

location_facility: Group Hospier Pitie-Salpetriere / Maladies Infec et Trop

location_facility: Groupe Hospitalier Bichat-Claude Bernard

location_facility: Hopital de Purpan / CHU de Rangueil / Medecine Interue

location_facility: Hopital de Purpan / Service du Professeur Auvergnat