title: Induction of Regulatory T Cells for the Treatment of Recently Diagnosed Type 1 Diabetes: Dose Finding Study of the Lowest Active Dose of IL-2 in Children

summary: Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key role in the regulation of the immune system. At high doses, rhIL-2 activates the immune effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells (TREGS), a population of immune cells controlling the immune Teff response. In patients with Type 1 Diabetes (T1D), TREGS fail to control the autoimmune destruction by TEFFS of pancreatic beta-cells producing insulin. The investigator recently showed that rhIL-2 at low dose is well tolerated in patients with an autoimmune disease and in adults with established T1D, inducing TREGS without effects on TEFFS. The investigators aim to use rhIL-2 at low dose to induce/stimulate TREGS in young recently diagnosed T1D patients. This study will investigate the dose effect relationship of low dose rhIL-2 on TREG induction such as to optimize the risk benefit ratio of this treatment in T1D. Through Treg induction, the investigators aim to protect the remaining/regenerating pancreatic β-cells from autoimmune destruction, thus improving or even curing T1D.

ReferenceCitation: Rosenzwajg M, Salet R, Lorenzon R, Tchitchek N, Roux A, Bernard C, Carel JC, Storey C, Polak M, Beltrand J, Amouyal C, Hartemann A, Corbeau P, Vicaut E, Bibal C, Bougneres P, Tran TA, Klatzmann D. Low-dose IL-2 in children with recently diagnosed type 1 diabetes: a Phase I/II randomised, double-blind, placebo-controlled, dose-finding study. Diabetologia. 2020 Sep;63(9):1808-1821. doi: 10.1007/s00125-020-05200-w. Epub 2020 Jul 1.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

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

location_facility: Service d'endocrinologie Diabétologie pédiatrique CHU Robert Débré

location_facility: Service d'endocrinologie pédiatrique - CHU de Necker


title: CIRCE: Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients

acronym: CIRCE

summary:
Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well understood in absence of studies taking into account all recognised factors. A large scale clinical, biochemical and molecular studies is potentially relevant to the understanding of nutrition, physical activity, body weight metabolic syndrome whatever the etiology of underlying cirrhosis. It will open new perspectives :

in prevention of hepatocellular carcinoma development in cirrhotic patients through dietary counselling and therapeutics of metabolic syndrome,
in early screening of hepatocellular carcinoma in cirrhotic patients through spectroscopic technology and later proteomic study resulting in an improvement of hepatocellular carcinoma prognosis.

study_start_date_type: Actual

status: Completed

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Clinique médicale B. Hôpital Civil-Hôpitaux Universitaires

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer

acronym: PROFILER

summary:
It is a non-randomized, multicentric, cohort study, combined with a biological sample collection, a clinical data collection and with a genetic and immunologic biomarkers study.

The ProfiLER program aims to implement a personalized cancer medicine approach by proposing to establish the genetic and immunologic profile of the tumor for patients with an advanced malignant tumor, in order to define a map of genetic (for the pre-identified target genes) and immunologic profiles for all the studied types of cancer. This study will also allow adapting the therapeutic management of these patients, if needed, by giving them targeted therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the recommendations of the multidisciplinary molecular board.

The genetic and immunologic profile of the tumor will be determined from archival or fresh collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The correlation between genetic profiles of the tumor, patients immunity status and clinical data (progression, tumor response, etc.) collected from the patient medical records will probably allow us to identify biomarkers with a potential predictive value and to determine if some genetic disorders are linked to immunity status alterations.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: background

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ReferenceType: derived

ReferenceCitation: Benezech S, Saintigny P, Attignon V, Pissaloux D, Paindavoine S, Faure-Conter C, Corradini N, Marec-Berard P, Bergeron C, Cassier P, Eberst L, Dufresne A, Wang Q, Agrapart V, De La Fouchardiere A, Perol D, Garin G, Corset V, Ben Abdesselem L, Chabaud S, Tredan O, Blay JY, Frappaz D. Tumor Molecular Profiling: Pediatric Results of the ProfiLER Study. JCO Precis Oncol. 2020 Nov;4:785-795. doi: 10.1200/PO.20.00023.

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ReferenceCitation: Tredan O, Wang Q, Pissaloux D, Cassier P, de la Fouchardiere A, Fayette J, Desseigne F, Ray-Coquard I, de la Fouchardiere C, Frappaz D, Heudel PE, Bonneville-Levard A, Flechon A, Sarabi M, Guibert P, Bachelot T, Perol M, You B, Bonnin N, Collard O, Leyronnas C, Attignon V, Baudet C, Sohier E, Villemin JP, Viari A, Boyault S, Lantuejoul S, Paindavoine S, Treillleux I, Rodriguez C, Agrapart V, Corset V, Garin G, Chabaud S, Perol D, Blay JY; ProfiLER investigators. Molecular screening program to select molecular-based recommended therapies for metastatic cancer patients: analysis from the ProfiLER trial. Ann Oncol. 2019 May 1;30(5):757-765. doi: 10.1093/annonc/mdz080.

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ReferenceCitation: Jiang X, Pissaloux D, De La Fouchardiere C, Desseigne F, Wang Q, Attignon V, Fondrevelle ME, De La Fouchardiere A, Perol M, Cassier P, Seigne C, Perol D, Ray-Coquard I, Meeus P, Fayette J, Flechon A, Le Cesne A, Penel N, Tredan O, Blay JY. The sum of gains and losses of genes encoding the protein tyrosine kinase targets predicts response to multi-kinase inhibitor treatment: Characterization, validation, and prognostic value. Oncotarget. 2015 Sep 22;6(28):26388-99. doi: 10.18632/oncotarget.4557.

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CHU de Saint-Etienne Hôpital Nord
Hôpital Edouard Herriot
Centre Hospitalier Annecy Genevois
Groupement Hospitalier Mutualiste
Centre Hospitalier Lyon Sud

intervention_type: Genetic

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type: EudraCT Number

title: A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.

acronym: LaserMucite

summary: The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.

status: Unknown status

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Legoute F, Bensadoun RJ, Seegers V, Pointreau Y, Caron D, Lang P, Prevost A, Martin L, Schick U, Morvant B, Capitain O, Calais G, Jadaud E. Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial. Radiat Oncol. 2019 May 22;14(1):83. doi: 10.1186/s13014-019-1292-2.

evidence: oa journal (via doaj)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Centre hospitalier universitaire La Milétrie

location_facility: Institut de Cancerologie de l'Ouest Paul Papin

lead_sponsor_type: industriel

status_simplified: Unknown


title: Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.

acronym: Endophtalmitis

summary: One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.

study_completion_date_type: Actual

location_facility:
CHU de Nancy
CHU
CHU de Strasbourg
CHU de Saint Etienne
CHU de Grenoble
CHU de Besançon


title: A PHASE IB STUDY OF THE BTKi CC-292 COMBINED WITH LENALIDOMIDE IN ADULTS PATIENTS WITH RELAPSED/REFRACTORY B-CELL LYMPHOMA

acronym: CLEAR

summary: This is an open label, 3 + 3 dose escalation study, to determine the MTD, safety, efficacy and PK profiles for subjects with relapsed/refractory B-cell malignancies when using CC-292 and lenalidomide combination therapy. Subjects will be followed for disease progression and collection of second primary malignancy (SPM) events. This dose escalation will be followed by an exploratory expansion phase in 3 cohorts of 12 patients each.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHU Lyon Sud
Institut Paoli Calmette
CHU de Lille
CHU de Toulouse
CHU de Nantes
Hopital henri mondor

intervention_type: Drug


title: A Prospective, Multicenter, Randomized, Controlled, Parallel-group, Open Label Trial Evaluating Benefits of Nasal High Flow Therapy (HFT) in Preoxygenation Before Tracheal Intubation in Acute Hypoxemic Respiratory Failure

acronym: PREOXYFLOW

summary:
Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event.

The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure

ReferenceCitation: Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

oa_colors: green other

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

repositories_concat: HAL

lead_sponsor: Nantes University Hospital

location_facility: Nantes Universitary Hospital, medical intensive care unit

location_facility: Nantes Universitary Hospital, surgical intensive care unit

intervention_type: Device


title: Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE)

acronym: LUPSENIC

summary:
Primary objectives :

To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE,
To determine the maximum tolerated dose of ATO.

Secondary objectives :

Evaluation of the clinical and biological response of the SLE to ATO,
Time of relapse in case of positive response,
Determination of the efficacy,
Pharmacokinetic study of ATO.

status: Terminated

ReferenceCitation: Hamidou M, Neel A, Poupon J, Amoura Z, Ebbo M, Sibilia J, Viallard JF, Gaborit B, Volteau C, Hardouin JB, Hachulla E, Rieger F. Safety and efficacy of low-dose intravenous arsenic trioxide in systemic lupus erythematosus: an open-label phase IIa trial (Lupsenic). Arthritis Res Ther. 2021 Mar 3;23(1):70. doi: 10.1186/s13075-021-02454-6.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

sponsor_collaborators:
Nantes University Hospital
Medsenic Company

location_facility:
AP-HP - la Pitié-Salpétrière
Nantes University Hospital
CHRU de Strasbourg
CHRU de Lille
CHU de Marseille
CHU de Bordeaux


title: A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma

acronym: SUN-CK

summary:
For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered as the reference treatment in first line chemotherapy. However, the outcomes of these patients remain limited and therefore more effective drugs are warranted. The context of the disease and current data on sunitinib suggest that sunitinib may have activity in patients with advanced non resectable cholangiocarcinoma.

Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity of sunitinib in such a patient population.

ReferenceCitation: Dreyer C, Sablin MP, Bouattour M, Neuzillet C, Ronot M, Dokmak S, Belghiti J, Guedj N, Paradis V, Raymond E, Faivre S. Disease control with sunitinib in advanced intrahepatic cholangiocarcinoma resistant to gemcitabine-oxaliplatin chemotherapy. World J Hepatol. 2015 Apr 28;7(6):910-5. doi: 10.4254/wjh.v7.i6.910.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: Baishideng Publishing Group Inc.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Saint Antoine
Institut Mutualiste Montsouris
Hôpital privé Jean Mermoz
CHU La Timone
Hôpital Beaujon
Institut Gustave Roussy


title: Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study

acronym: SIRUP

summary: The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.

ReferenceCitation: Zerbib F, Sacher-Huvelin S, Coron E, Coffin B, Melchior C, Ponchon T, Cholet F, Chabrun E, Vavasseur F, Gorbatchef C, Zalar A, Mion F, Robaszkiewicz M, Le Rhun M, Leroy M, Paul Galmiche J, Bruley des Varannes S. Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn. Aliment Pharmacol Ther. 2020 Aug;52(4):637-645. doi: 10.1111/apt.15936. Epub 2020 Jul 13.

oa_host_type: closed

publisher_dissemination: Wiley

location_facility:
Nantes Universitary Hospital
Rouen Universitary Hospital
Brest universitary hospital
APHP - Louis Mourier hospital
Lyon Universitary Hospital
Bordeaux Universitary Hospital

intervention_type: Other


title: Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65

acronym: LATMM

summary: Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Garderet L, Beohou E, Caillot D, Stoppa AM, Touzeau C, Chretien ML, Karlin L, Moreau P, Fontan J, Blaise D, Polge E, Gueye MS, Ikhlef S, Marjanovic Z, Labopin M, Mohty M. Upfront autologous stem cell transplantation for newly diagnosed elderly multiple myeloma patients: a prospective multicenter study. Haematologica. 2016 Nov;101(11):1390-1397. doi: 10.3324/haematol.2016.150334. Epub 2016 Sep 9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

endpoint_id: HAL

repository_institution: HAL

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

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU
Hôpital Saint Antoine
Institut Paoli Calmette


title: A Multicenter, Open-label, Single Arm, Long-term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis

summary: This open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

lead_sponsor: Hoffmann-La Roche


title: Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility

acronym: ProAcTyon

summary: Non-interventional study consisting of a population of patients who had received for soft tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.

time_perspective: Retrospective

lead_sponsor: Centre Oscar Lambret

location_facility:
Curie Institute
Henri Becquerel Center
Oscar Lambret Center
Bergonie Institute
Cancer Institute of the West
Antoine Lacassagne Center


title: tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study

acronym: STICODEP

summary:
The aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS) applied at the anodal left CDLPF of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant depression stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients and lithium for bipolar patients). The delay of 4 weeks is a minimum to observe a non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8 weeks to observe the non-response to treatment.

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients (48 unipolar plus 12 bipolar patients per group. Patients will be selected in the psychiatric department of the University Hospital of different centers and the two groups are matched for age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).

After giving informed consent, patients will be evaluated by a psychiatrist using the Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS), the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young Mania Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist assessment will be also realized during 20 minutes using the Crossing of Test (COT), the Trail Making Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.

After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 30-minute session. A psychometric assessment will be conducted again at the end of treatment week and 4, 12 and finally 24 weeks after stopping treatment. The neuropsychologist assessment will be conducted again 4 weeks after the end of treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment.

These people will be recruited on a voluntary basis, after notification and consent in the 6 research centers. This study was conducted over a period of 36 months.

This study was supporting by a grant from the French Hospital Program of Clinical Reseach (PHRC N/2011-60-2011-A01074-37)

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators: Clinical Investigation Centre for Innovative Technology Network

collaborators: CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET)

collaborators: EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL)

collaborators: Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy)

location_facility: CHU Grenoble - Clinique de Psychiatrie de l'Adulte

location_facility: Centre Hospitalier Guillaume Régnier - Rennes - Service Hospitalo-Universitaire de Psychiatrie

location_facility: Etablissement Public de Santé Mentale - Unité de Recherche Clinique

location_facility: CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)


acronym: PITAC

summary: The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.

location_facility:
Hôpital Laennec
Institut Bergonié
ICO Paul Papin
Centre Hospitalier
Polyclinique
Centre Oscar Lambret

title: Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.

source: euctr


title: Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

acronym: HAVIR Bi

summary: The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière


title: Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn

acronym: NEOCORD

summary: At birth, the umbilical cord is cut, separating physically and symbolically the mother of his child. Before cord drop, umbilical area is a possible way of bacterial infection. Thus, umbilical cord infections constitute a major cause of neonatal morbidity and mortality in developing countries. In industrialized countries, omphalitis cases have almost disappeared whatever cord care strategies. At this day, care practices appear extremely different between countries, based more on habits and convictions that on evidence-based medicine. The investigators propose to conduct a non inferiority multicenter clustered crossed randomized study. Observations sessions will be performed on two consecutive periods of 5 months: 4 months of recruitment and 1 month follow-up. Main objective is to demonstrate that dry cord care practice would not expose to a higher risk of omphalitis than antiseptic based care approach. The purpose of NEOCORD study is a simplification of cord care for paramedical teams and parents, but also a significant reduction of costs in a medico-economic approach.

ReferenceCitation: Gras-Le Guen C, Caille A, Launay E, Boscher C, Godon N, Savagner C, Descombes E, Gremmo-Feger G, Pladys P, Saillant D, Legrand A, Caillon J, Barbarot S, Roze JC, Giraudeau B. Dry Care Versus Antiseptics for Umbilical Cord Care: A Cluster Randomized Trial. Pediatrics. 2017 Jan;139(1):e20161857. doi: 10.1542/peds.2016-1857.

publisher_dissemination: American Academy of Pediatrics (AAP)

location_facility:
Pr PLADYS Patrick
Dr GREMMO-FREGER Gisèle
Dr SAVAGNER Christophe
Pr SALIBA Elie
Dr DESCOMBES-BARROSO Emmanuelle
Dr GRAS-LEGUEN


title: Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)

acronym: ORISA

summary: The primary objective of this study is to detect differences in anti-S. aureus antibody assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of patients with localized chronic wound infections (control).

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

intervention_type: Biological


acronym: BPOP

summary: The purpose of the study is to determine the efficacity of a simple blind technic of loco regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the prehospital setting and mountain rescue.

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Centre Hospitalier de la Region d'Annecy

location_facility: Centre Hospitalier Universitaire de GRENOBLE

location_facility: Centre Hospitalier d'Albertville moutiers


title: Double Blind Randomized Controlled Trial Comparing "Atropine+Propofol" Versus "Atropine+Atracurium+Sufentanil" as a Premedication Prior to Semi-urgent or Elective Endotracheal Intubation of Term and Preterm Newborns

acronym: PRETTINEO

summary:
Multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome.

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.

ReferenceType: result

ReferenceCitation: Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.

publisher_dissemination: American Medical Association

ReferenceCitation: Tauzin M, Marchand-Martin L, Lebeaux C, Breinig S, Claris O, Tourneux P, Alexandre C, Levy C, Jung C, Dechartres A, Durrmeyer X; PREmedication Trial for Tracheal Intubation of the NEOnate Research Group. Neurodevelopmental Outcomes after Premedication with Atropine/Propofol vs Atropine/Atracurium/Sufentanil for Neonatal Intubation: 2-Year Follow-Up of a Randomized Clinical Trial. J Pediatr. 2021 Apr;231:273-277.e3. doi: 10.1016/j.jpeds.2020.12.001. Epub 2020 Dec 8.

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Association Clinique Thérapeutique Infantile du val de Marne

location_facility: Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord


title: Evaluation of Interests of the Functional Insulin Therapy (FIT Therapy) on Metabolic Control, Hypoglycemia Prevention and Life Quality of Diabetics Children Insulin-dependent Treated With Insulin Pump.

acronym: DIABFIT

summary: Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic control, hypoglycemia prevention and life quality of diabetics children insulin-dependent treated with insulin pump.

ReferenceCitation: Langewitz W, Wossmer B, Iseli J, Berger W. Psychological and metabolic improvement after an outpatient teaching program for functional intensified insulin therapy (FIT). Diabetes Res Clin Pract. 1997 Sep;37(3):157-64. doi: 10.1016/s0168-8227(97)00071-5.

ReferenceCitation: Hartemann-Heurtier A, Sachon C, Masseboeuf N, Corset E, Grimaldi A. Functional intensified insulin therapy with short-acting insulin analog: effects on HbA1c and frequency of severe hypoglycemia. An observational cohort study. Diabetes Metab. 2003 Feb;29(1):53-7. doi: 10.1016/s1262-3636(07)70007-1.

ReferenceCitation: Samann A, Muhlhauser I, Bender R, Kloos Ch, Muller UA. Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study. Diabetologia. 2005 Oct;48(10):1965-70. doi: 10.1007/s00125-005-1905-1. Epub 2005 Aug 18.

ReferenceCitation: Lowe J, Linjawi S, Mensch M, James K, Attia J. Flexible eating and flexible insulin dosing in patients with diabetes: Results of an intensive self-management course. Diabetes Res Clin Pract. 2008 Jun;80(3):439-43. doi: 10.1016/j.diabres.2008.02.003. Epub 2008 Mar 18.

ReferenceCitation: Grimm JJ, Ybarra J, Berne C, Muchnick S, Golay A. A new table for prevention of hypoglycaemia during physical activity in type 1 diabetic patients. Diabetes Metab. 2004 Nov;30(5):465-70. doi: 10.1016/s1262-3636(07)70144-1.

lead_sponsor: University Hospital, Angers

location_facility: University Hospital of Angers Service of Pediatric Diabetology and Endocrinology


title: Management of Nausea and Vomiting Chemotherapy-induced in Normandy

acronym: NAVI

summary: The objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Maurice Tubiana
Centre hospitalier
Centre Jacques Monod
Centre hospitalier public du cotentin
Centre de la Baie
Centre François Baclesse


title: Evaluation of Language and Sensorimotor Constraints of Very Premature Babies at the Age of 3 Years 1 / 2 Without Cerebral Palsy. Randomised Study of Stimulation Training Implicit in Children Vulnerable

acronym: LAMOPRESCO

summary:
The preterm children have more difficulty minor neurological developmental than the general population even without cerebral palsy. Their oral language difficulties of language and writing have been little studied. The investigators propose to study spoken language has 3 years 1/2 and stimulate or not (depending on randomization) children with phonological weaknesses notemment language. The investigators will evaluate stimulation protocol implied short and precise language in a re-education "say and do" in 20 sessions. A new evaluation of language (BILO and N-EEL), sensorimotor and cognitive constraints (KABC) will be performed at 4 years.

Early intervention on the basis of precise language before closing the window developmental (<5 years) is expected to improve as a result of language and cognitive development of preterm infants.

ReferenceCitation: Charollais A, Stumpf MH, Beaugrand D, Lemarchand M, Radi S, Pasquet F, Khomsi A, Marret S. [Evaluation of language at 6 years in children born prematurely without cerebral palsy: prospective study of 55 children]. Arch Pediatr. 2010 Oct;17(10):1433-9. doi: 10.1016/j.arcped.2010.06.012. Epub 2010 Aug 16. French.

lead_sponsor: University Hospital, Rouen

sponsor_collaborators:
University Hospital, Rouen
European Regional Development Fund

location_facility:
Centre Jacques Cartier
University Hospital

intervention_type: Behavioral


title: Evaluation of Post Traumatic Stress Among the Nearest Relatives of Brain-dead, Withdrawal of Life Support, and Sudden Death Patients

summary: This study concerns the nearest relatives of patients who have passed away within 3 days of admission to an ICU due to: (1) brain death with multiple organ donation +/- tissues or (2) death via limitation and / or cessation of active treatment (LATA) without brain death or (3) sudden death of a previously healthy patient (no physical or mental limitations; MacCabe score = 0) within 3 days of admission to ICU without LATA nor brain death. Our primary objective is to determine the proportion of nearest relatives at risk for post traumatic stress disorder as defined by an Impact of Event Scale score greater than 37, and to compare this factor between the three above-mentioned groups.

location_facility: Hôpital Gui De Chauliac (CHU de Montpellier)

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Assistance Publique - Hopitaux de Marseille


title: A Phase II, Randomized, Placebo-controlled Trial of the Safety, Efficacy, Pharmacodynamics and Pharmacokinetics of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A.

summary: The present trial is a randomized, placebo-controlled study evaluating 3 different doses of PXT3003 in patients with CMT1A disease.

ReferenceCitation: Attarian S, Vallat JM, Magy L, Funalot B, Gonnaud PM, Lacour A, Pereon Y, Dubourg O, Pouget J, Micallef J, Franques J, Lefebvre MN, Ghorab K, Al-Moussawi M, Tiffreau V, Preudhomme M, Magot A, Leclair-Visonneau L, Stojkovic T, Bossi L, Lehert P, Gilbert W, Bertrand V, Mandel J, Milet A, Hajj R, Boudiaf L, Scart-Gres C, Nabirotchkin S, Guedj M, Chumakov I, Cohen D. An exploratory randomised double-blind and placebo-controlled phase 2 study of a combination of baclofen, naltrexone and sorbitol (PXT3003) in patients with Charcot-Marie-Tooth disease type 1A. Orphanet J Rare Dis. 2014 Dec 18;9:199. doi: 10.1186/s13023-014-0199-0. Erratum In: Orphanet J Rare Dis. 2016;11(1):92.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;dash.harvard.edu

publisher_dissemination: Springer

lead_sponsor: Pharnext S.C.A.

location_facility:
CHU Dupuytren
CHU Lyon Sud
Hôpital Roger Salengro
Hôpital La Timone
Hôtel Dieu
Groupe Hospitalier Pitié-Salpétrière


type: Registry Identifier

title: Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer

acronym: EXSAL

summary: The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes

location_facility:
Dr Pascaline BERTHET
Centre Eugène MARQUIS
CHU
Centre Henri BECQUEREL
Centre Hospitalier


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


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.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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


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.

status: Active, not recruiting

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.

oa_colors: green hybrid

lead_sponsor: National Cancer Institute (NCI)

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


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.

location_facility: Hôpital Paule de Viguier, CHU de Toulouse


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, Salaun PY, Goldenberg DM, Sharkey RM, Kraeber-Bodere 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.

publisher_dissemination: Frontiers

lead_sponsor: Centre René Gauducheau

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


acronym: RS CAMPTO

lead_sponsor: Institut Cancerologie de l'Ouest

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).

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

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


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.

ReferenceCitation: Leroy A, Cottencin O, Labreuche J, Mascarel P, De Pourtales MA, Molenda S, Paget V, Lemogne C, Bougerol T, Gregory T, Chantelot C, Demarty AL, Meyer S, Warembourg F, Duhem S, Vaiva G. Four Questions Nurses Can Ask to Predict PTSD 1 Year After a Motor Vehicle Crash. J Trauma Nurs. 2022 Mar-Apr 01;29(2):70-79. doi: 10.1097/JTN.0000000000000638.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Lille

location_facility: Georges Pompidou European Hospital, Paris

location_facility: Catholic University Hospital of Lille Saint Vincent

location_facility: Catholic University Hospital of Lille Saint Philibert


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.

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.

lead_sponsor: Centre Hospitalier Departemental Vendee

sponsor_collaborators:
Centre Hospitalier Departemental Vendee
University Hospital, Tours

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


acronym: TALViSoP

lead_sponsor: University Hospital, Limoges

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

location_facility: Centre Hospitalier Universitaire - Hôpital Saint André

status: Suspended

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

primary_purpose: Supportive Care


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

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. doi: 10.1111/j.1471-0528.1989.tb03246.x. No abstract available.

ReferenceCitation: Johanson R, Menon V. Soft versus rigid vacuum extractor cups for assisted vaginal delivery. Cochrane Database Syst Rev. 2000;(2):CD000446. doi: 10.1002/14651858.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. doi: 10.1097/00006254-200111000-00025.

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. doi: 10.1111/j.1471-0528.2005.00729.x.

ReferenceCitation: Vacca A. A randomised controlled trial of a new handheld vacuum extraction device. BJOG. 2006 Apr;113(4):492; author reply 494-5. doi: 10.1111/j.1471-0528.2006.00903.x. No abstract available.

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. doi: 10.1111/j.1471-0528.2005.00834.x.

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(9):CD005455. doi: 10.1002/14651858.CD005455.pub3.

oa_host_type: repository

repository_institution: University of Pretoria - UpSpace Institutional Repository

repository_institution: Keele University - Keele Research Repository

version: acceptedVersion

unpaywall_oa_status: green

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(R) 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.

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

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

lead_sponsor: University Hospital, Grenoble

location_facility:
Hospital
University Hospital


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.

lead_sponsor: Nantes University Hospital

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


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.

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. doi: 10.1038/sj.cgt.7701098. 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.

lead_sponsor: Transgene

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


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

lead_sponsor: Sanofi Pasteur, a Sanofi Company

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: 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


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 Montpellier
CHU Saint Etienne
CHU Bordeaux
CHU Rouen
APHP Charles Foix


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.

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.

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


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 Pitié-Salpétrière

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


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


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:
Cherbourg Hospital
Flers Hospital
Alençon-Mamers Hospital
Lisieux Hospital
Caen University Hospital
Saint-Lo 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, Socie 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.

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

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


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

sponsor_collaborators: Bledina MAPI

location_facility:
Cabinet medical
Hôpital saint Vincent de Paul
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:
CHR Orléans
CH de Châteauroux
CH de Blois
CH de Bourges
CHRU de Tours
CH de Dreux


acronym: FAKIR

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.

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.

evidence: open (via free article)

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

title: Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability 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:
CH Saint Pierre La Réunion
CHU de Nice
CHU de Dijon
University hospital of Bordeaux
CHU Rennes
CHU Limoges


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.

lead_sponsor: Dr Maria-Atonietta D'AGOSTINO

collaborators: Groupe Français d'Etude Génétique des Spondylarthropathies

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


lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

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: 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(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

repository_institution: University of Bern - Bern Open Repository and Information System

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

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

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

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


acronym: NIMFEA

lead_sponsor: UNICANCER

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.

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.

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-Pelissier 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.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories_concat: PubMed Central;oskar-bordeaux.fr

repositories_institution:
PubMed Central - Europe PMC
Universite de Bordeaux - Oskar-Bordeaux

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

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.


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.

lead_sponsor: Centre Jean Perrin

collaborators:
Merck Sharp & Dohme LLC
Sanofi

sponsor_collaborators:
Centre Jean Perrin
Merck Sharp & Dohme LLC
Sanofi

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


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, Doffoel M, Trepo C, Agathon D, Toh ML, Baudin M, Bonnefoy JY, Limacher JM, Inchauspe 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.

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


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.

publisher_dissemination: Oxford University Press

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.

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.

lead_sponsor: Assistance Publique Hopitaux De Marseille

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


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, Ferriere JP, Amat S, Cure HD, Kwiatkowski FG, Feillel VA, Lebouedec 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. doi: 10.3816/cbc.2004.n.035.

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.

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