title: Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.

acronym: MYLY

summary:
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.

This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.

location_facility:
Hôpital Pitié Salpêtrière
CHU de Rennes Hôpital Pontchaillou
CHRU de Brest


title: Creation and Setting up of Therapeutic Programs, Interprofessional Communication, Patients' Education and Counseling: a Qualitative Study in 3 Physical Therapy and Rehabilitation Departments

acronym: EMCIQUAL

summary: The purpose of this study is to suggest system for improving patients' management through a detail analysis of physical therapy departments functioning

status: Completed

study_completion_date_type: Actual

study_type: Observational

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Coudeyre E, Rannou F, Tubach F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. General practitioners' fear-avoidance beliefs influence their management of patients with low back pain. Pain. 2006 Oct;124(3):330-337. doi: 10.1016/j.pain.2006.05.003. Epub 2006 Jun 5.

ReferenceCitation: Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706.

ReferenceCitation: Poiraudeau S, Rannou F, Le Henanff A, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Revel M, Ravaud P. Outcome of subacute low back pain: influence of patients' and rheumatologists' characteristics. Rheumatology (Oxford). 2006 Jun;45(6):718-23. Epub 2005 Dec 23.

ReferenceCitation: Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.

ReferenceCitation: Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14. Review.

ReferenceCitation: Coudeyre E, Demaille-Wlodyka S, Poizat S, Burton K, Hamonet MA, Revel M, Poiraudeau S. Could a simple educational intervention modify beliefs about whiplash? A preliminary study among professionals working in a rehabilitation ward. Ann Readapt Med Phys. 2007 Oct;50(7):552-7, 545-51. Epub 2007 Jun 18. English, French.

ReferenceCitation: Coudeyre E, Givron P, Vanbiervliet W, Benaïm C, Hérisson C, Pelissier J, Poiraudeau S. [The role of an information booklet or oral information about back pain in reducing disability and fear-avoidance beliefs among patients with subacute and chronic low back pain. A randomized controlled trial in a rehabilitation unit]. Ann Readapt Med Phys. 2006 Nov;49(8):600-8. Epub 2006 May 26. French.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHU Raymond Poincaré- Groupement hospitalier universitaire Ouest

lead_sponsor_type: academique

status_simplified: Completed


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints

summary: To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: NeuroHealing Pharmaceuticals Inc.

location_facility:
Hôpital Haut Lévêque
Hôpital de la Salpêtrière
Hôpital Paul de Viguier

intervention_type: Drug

lead_sponsor_type: industriel


title: Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.

acronym: HRM RTSIO

summary: The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility: Institut des Maladies de l'Appareil Digestif (IMAD)

location_facility: Service d'hépato-gastroentérologie et oncologie digestive

location_facility: Service d'Exploration Fonctionnelle Digestive

intervention_type: Procedure


type: Other Identifier

title: Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay

acronym: HOT

summary: The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

status_simplified: Unknown


title: Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.

acronym: IPEC-GC

summary: If surgery remains the main treatment for gastric cancer without distant metastases; perioperative-chemotherapy increased the likelihood of progression free survival. Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients could received post-chemotherapy, due to post-operative complications and toxicities. To overcome this limitation, the investigators will conduct a phase II clinical trial assessing the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P), epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and paclitaxel/epirubicin combinations, sustain the development of dose density based on PET combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the effectiveness of this PET preoperative regimen

ReferenceType: result

ReferenceCitation: Jary M, Ghiringhelli F, Jacquin M, Fein F, Nguyen T, Cleau D, Nerich V, El Gani M, Mathieu P, Valmary-Degano S, Arnould L, Lassabe C, Lamfichekh N, Fratté S, Paget-Bailly S, Bonnetain F, Borg C, Kim S. Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer. Cancer Chemother Pharmacol. 2014 Jul;74(1):141-50. doi: 10.1007/s00280-014-2482-0. Epub 2014 May 14.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
FNLCC center Georges François Leclerc
Hospital of Belfort-Montbeliard
University hospital of Besançon


type: Registry Identifier

title: Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

summary: The aim of the study is to assess the beneficial effect of the short term consumption of the highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low mineralized water.

primary_purpose: Prevention

lead_sponsor: Neptune

location_facility: Biofortis OPTIMED Naturalpha

intervention_type: Other


title: Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.

acronym: MEDOC

summary:
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with prevalence of patients on this type of therapy steadily increasing. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the relationship thrombosis / hemorrhage.

Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned gradually to the usual practice. However, these procedures are still not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the literature.

It is necessary to achieve a large national multicenter study, to clarify the risk of post recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures used in daily practice by endoscopists in expert centers (clip, ligature and loop devices, preventive adrenalin injection).

The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding after colonic polypectomy and / or EMR for patients on clopidogrel.

It is expected in this work an incidence of post-polypectomy bleeding close to that observed during the implementation of these actions in the population without any anti platelet agents.

study_start_date_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: EXPLORATION OF THE SOCIAL COGNITION IN ADOLESCENTS WITH A Dissociative Disorder OR AUTISM SPECTRUM

summary:
The schizophrenic disorders and pervasive developmental disorders are neurodevelopmental disorders distinct origin who share common challenges to engage and maintain social relationships and mutual disturbances of affective contact. An important issue of research is to determine the cognitive and brain mechanisms underlying social disability in these two pathologies. Several lines of social cognition have been systematically explored: the perception of emotions, the ability to attribute intentionality and mental states to others (theory of mind), the understanding of social situations in different contexts. We made the observation today that research findings clearly in the field of autism and schizophrenic disorders that converge on common patterns neurocognitive abnormalities. Consequently, many programs support published today use the same therapeutic targets and the same tools in both pathologies. This raises two questions of science: (1) whether the disorders of social cognition reported in the field of autism and schizophrenia are "specific deficit" and not "specific condition", that is to say they are inherent social disadvantage whatever condition or (2) if these disorders of social cognition is a pattern common to autism and schizophrenia but are the result of specific neurocognitive mechanisms and different in each these pathologies. Systematic exploration of these issues is a current issue for understanding the pathophysiological borders between the two neurodevelopmental disorders but also to better define the potential targets of therapeutic strategies, psycho-educational and remediation of disorders of social cognition in autism and schizophrenia.

Main objective: To compare clinical cognitive profiles in adolescents with a schizophrenic disorder, autistic or healthy in the three areas of social cognition: perception of emotions, attribution of intentions to others (theory of mind) and style attribution. We shall constitute three population groups of patients, a group of patients meeting the diagnosis of schizophrenia, a group of patients with autism and a control group (healthy subjects).

design_allocation: Non-Randomized

enrollment_type: Anticipated

location_facility: Centre Hospitalier d'Antibes Juans les Pins


title: VERVE* PROJECT: Study of the Acceptability of a Virtual Reality System on the Cognitive Stimulation of Patients With Alzheimer's Disease or Related Conditions. (*Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment)

acronym: VERVE

summary:
Virtual environments and information communication technologies (ICT) offer large perspectives in the field of assistive care and rehabilitation.

As potentially endless, the scenarios and environment used using 3D can provide immersive social and interactive context for enjoyable and therapeutic exercises in the aging population. In addition it is also possible to use this type of serious game and scenario in very easy to use devices such as lap top or tablet.

Social exclusion has many causes, Apathy as one of the most common behavioural disturbances found in old adults populations alters significantly social and emotional interaction.

Even though, progress in VR has been made over the past year, the presence of such technology in daily living space is still at the embryonic stage.

The European e-Inclusion policy stresses the importance of ICT in improving the quality of life in potentially disadvantaged groups, including older people and persons.

The VERVE project is developing ICT tools to support the treatment of people who are at risk of social exclusion due to apathy associated with a disability.

As people aged and autonomy worsen fear for safety and comfortable means to maintain social and Health Related Quality of Life (HRQL) status are public health issues.

Moreover, even though older adults would like to perform some activities such as walking in the streets some are reluctant to go out of their homes as the external environment is perceived as potentially unsafe.

Apathy, the most common behavioural symptoms in aging population is characterized by symptoms of reduced initiation and responsiveness to environmental interactions. The syndrome of Apathy takes form of diminished goal-directed behaviour, characterised by emotional blunting, loss of initiative and loss of interest. Apathy along with the nosological characteristics of dementia induces impairment in autonomy level and therefore dependence as cognitive impairments worsened.

The importance of stimulation could be related to the concept of engagement defined as the act of being occupied or involved with an external stimulus. Engaging older person with or without Alzheimer's disease and related disorders in appropriate activities has been shown to yield beneficial HRQL effects such increasing positive emotion, improving cognition, functional autonomy and quality of life.

Accordingly, enriched environments with high definition virtual representation of cities and activities of interest have the potentials not only to encourage patients to get active in a safe and interactive environment but also to create access to enjoyable and stimulating settings for the more severe patients.

The VR setting from VERVE proposed personalised and populated environments available on two different, but interlinked hardware platforms: 1/: standard gaming set-up in the home, nursing home or day hospital therapy group; and 2/ mobile tracked internet devices (e.g.,IPad). The system will ensure maximum openness and dissemination by using 3D Web technologies.

primary_purpose: Health Services Research

location_facility:
EHPAD Villa Hélios Saint Jean
EHPAD Valrose
CHU de Nice


acronym: TOCIDYS

title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.

lead_sponsor: Hospices Civils de Lyon

source: euctr

location_facility: Service de Rhumatologie, Groupe Hospitalier Pellegrin

location_facility: Service de rhumatologie, Hopital Edouard Herriot, HCL

location_facility: Service de rhumatologie, Hôpital Lariboisière

summary: Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.


title: Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human

acronym: CESNA

summary: The purpose of this project is to determine during moderate rise of intracranial pressure (ICP) in awake patient, the change in autonomic function and its influence on cerebral and systemic haemodynamics.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital of Toulouse
University Hospital Toulouse
University Hospital


title: Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.

acronym: Pascal

summary: The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de la Croix Rousse
Hôpital Lariboisière
CHU Dijon


title: Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

summary:
The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
University Hospital of Toulouse
University Hospital of Grenoble
Centre Hospitalier Sud Francilien


title: Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III

summary:
TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of RD94 in patients needing endodontic care, medical device class III.

SPONSOR:

SEPTODONT, 58 rue de Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91

Reference protocol: 09/001

PRODUCT NAME: Biodentine™ (RD94)

MEDICAL DEVICE:

Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class III)

lead_sponsor: Ascopharm Groupe Novasco

location_facility: Service d'Odontologie Hôpital Rothschild

location_facility: Cabinet de Chirurgie Dentaire rue Saint Didier

location_facility: Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière

intervention_type: Device


title: Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

acronym: TENOR

summary:
Phase 1:

Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.

Phase 2:

All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .

ReferenceType: derived

ReferenceCitation: Carvajal Alegria G, Garrigues F, Bettacchioli E, Loeuille D, Saraux A, Cornec D, Devauchelle-Pensec V, Renaudineau Y. Tocilizumab controls bone turnover in early polymyalgia rheumatica. Joint Bone Spine. 2021 May;88(3):105117. doi: 10.1016/j.jbspin.2020.105117. Epub 2020 Dec 7.

ReferenceCitation: Laporte JP, Garrigues F, Huwart A, Jousse-Joulin S, Marhadour T, Guellec D, Cornec D, Devauchelle-Pensec V, Saraux A. Localized Myofascial Inflammation Revealed by Magnetic Resonance Imaging in Recent-onset Polymyalgia Rheumatica and Effect of Tocilizumab Therapy. J Rheumatol. 2019 Dec;46(12):1619-1626. doi: 10.3899/jrheum.180958. Epub 2019 Mar 15.

ReferenceCitation: Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.

lead_sponsor: University Hospital, Brest

location_facility:
CHR d'Orléans
Nantes University Hospital
Brest University Hospital


title: Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

summary: Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Centre Oscar Lambret
Institut Gustave Roussy
Hopital Lariboisière


title: Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

summary: This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support

status: Withdrawn

study_completion_date_type: Anticipated

primary_purpose: Supportive Care

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Régional et Universitaire - Hopital CALMETTE

location_facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ


title: Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms

acronym: abl LMC

summary: The main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence of primary resistance to the treatment of CML by imatinib.

time_perspective: Cross-Sectional

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Phase I Trial of Afatinib in Combination With 3 Weekly Trastuzumab in Patients With Tumours Overexpressing HER2. Once the MTD of Afatinib With 3 Weekly Trastuzumab Was Established the Safety of This Dose Will be Assessed Also in Combination With Weekly Trastuzumab.

summary: The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.

lead_sponsor: Boehringer Ingelheim

location_facility:
CTR Georges-François Leclerc
CTR René Gauducheau, Onco, St Herblain
INS Claudius Regaud


acronym: HYDRAREA

summary: The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

lead_sponsor: University Hospital, Caen

location_facility:
Surgical Intensive Care Unit
Intensive care unit
Medical Intensive Care Unit


acronym: LYLO

summary: Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been shown to be altered very early, up to 13 years before dementia. This test, as many others executive function tests, requires a fine control of visuomotor coordination. Like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).

time_perspective: Prospective

location_facility:
Lyon UniversityHospital
AP-HM
CHU de Bordeaux Hôpital Haut Lévêque


title: Living Conditions and Breast Cancer

summary: The main objective of this study is to estimate of the link (odds ratio) between the precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at diagnosis (2 groups: CAS: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).

location_facility: IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique


title: Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma: Chest Radiograph Versus Chest CT

summary:
Cancer surveillance has a significant cost and generate anxiety for the patient.

It is important to avoid exams that will not modify health support or whose results wont allow to decide.

ipd_sharing: No

location_facility:
Léon BERARD Center
Centre Georges François Leclerc
Oscar Lambret Center


title: Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants

summary:
Hospital-acquired infections are common complications in preterm infants. The diagnosis has to be fast and accurate. Indeed, the early identification of a suspected infection is very important, since the early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Besides, a high specificity in the diagnosis of infection allows for the reduction of inappropriate treatment and thus prevents the emergence of antibiotic resistance.

The aim of this study is to develop a computer-assisted diagnosis tool, based on the real time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of infection of the preterm infant, at the bedside.

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Lille
CHU Angers
CHU de Rennes


acronym: IDEALE

title: Prospective, Multicenter, Randomized, Open-label, Phase 2, Lasting 12 Weeks, Evaluating the Pharmacodynamics, Efficacy and Safety of Basiliximab in de Novo Adult Renal Transplant Patients at Low Risk Receiving Either a Cumulative Dose of Basiliximab of 40 or 80 mg in Combination With Cyclosporine Microemulsion, or a Cumulative Dose of 80 mg of Basiliximab Without Calcineurin Inhibitor, With Additional Follow-up of 12 Weeks

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Thibault G, Paintaud G, Legendre C, Merville P, Coulon M, Chasseuil E, Ternant D, Rostaing L, Durrbach A, Di Giambattista F, Büchler M, Lebranchu Y. CD25 blockade in kidney transplant patients randomized to standard-dose or high-dose basiliximab with cyclosporine, or high-dose basiliximab in a calcineurin inhibitor-free regimen. Transpl Int. 2016 Feb;29(2):184-95. doi: 10.1111/tri.12688. Epub 2015 Oct 8.

summary:
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®.

It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.


title: Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain

summary: The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Polyclinique de L'Europe
Hôtel-Dieu CHU Nantes
Ambroise Paré Hospital


title: Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment

acronym: OPTIVUS

summary: Coronary angioplasty is rather frequently performed in such situations, presumably because, changes in the atherosclerotic plaque under drug treatment, have remained poorly described so far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma, better than the one provided by coronary angiography.

location_facility:
UH Limoges
UH Bordeaux Haut-Lévêque
UH Toulouse


title: Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

acronym: RoboProstate

summary:
The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.

The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

status_simplified: Ongoing


title: Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

acronym: CONTACT

summary:
This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.

On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed.

The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.

Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making.

For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :

Ruling out malignancy for patients with benign appearing nCLE images.
Characterizing more malignant tumors in the pancreas.
Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.

status: Unknown status

ReferenceCitation: Adsay NV. Cystic neoplasia of the pancreas: pathology and biology. J Gastrointest Surg. 2008 Mar;12(3):401-4. Epub 2007 Oct 24. Review.

ReferenceCitation: Levy MJ, Clain JE. Evaluation and management of cystic pancreatic tumors: emphasis on the role of EUS FNA. Clin Gastroenterol Hepatol. 2004 Aug;2(8):639-53. Review.

ReferenceCitation: Hutchins GF, Draganov PV. Cystic neoplasms of the pancreas: a diagnostic challenge. World J Gastroenterol. 2009 Jan 7;15(1):48-54. Review.

ReferenceCitation: Attasaranya S, Pais S, LeBlanc J, McHenry L, Sherman S, DeWitt JM. Endoscopic ultrasound-guided fine needle aspiration and cyst fluid analysis for pancreatic cysts. JOP. 2007 Sep 7;8(5):553-63.

ReferenceCitation: Becker V, Vercauteren T, von Weyhern CH, Prinz C, Schmid RM, Meining A. High-resolution miniprobe-based confocal microscopy in combination with video mosaicing (with video). Gastrointest Endosc. 2007 Nov;66(5):1001-7. Epub 2007 Sep 4.

ReferenceCitation: Meining A, Saur D, Bajbouj M, Becker V, Peltier E, Höfler H, von Weyhern CH, Schmid RM, Prinz C. In vivo histopathology for detection of gastrointestinal neoplasia with a portable, confocal miniprobe: an examiner blinded analysis. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1261-7. Epub 2007 Aug 6.

ReferenceCitation: Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. Epub 2006 Jul 13.

ReferenceCitation: Pohl H, Rösch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28.

ReferenceCitation: Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.

ReferenceCitation: Meining A, Frimberger E, Becker V, Von Delius S, Von Weyhern CH, Schmid RM, Prinz C. Detection of cholangiocarcinoma in vivo using miniprobe-based confocal fluorescence microscopy. Clin Gastroenterol Hepatol. 2008 Sep;6(9):1057-60. doi: 10.1016/j.cgh.2008.04.014. Epub 2008 Jul 17.

ReferenceCitation: Meining A, Phillip V, Gaa J, Prinz C, Schmid RM. Pancreaticoscopy with miniprobe-based confocal laser-scanning microscopy of an intraductal papillary mucinous neoplasm (with video). Gastrointest Endosc. 2009 May;69(6):1178-80. doi: 10.1016/j.gie.2008.06.013. Epub 2009 Jan 18.

ReferenceCitation: Konda VJ, Aslanian HR, Wallace MB, Siddiqui UD, Hart J, Waxman I. First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos). Gastrointest Endosc. 2011 Nov;74(5):1049-60. doi: 10.1016/j.gie.2011.07.018. Epub 2011 Sep 15.

ReferenceCitation: Giovannini M, Caillol F, Poizat F, Bories E, Pesenti C, Monges G, Raoul JL. Feasibility of Intratumoral Confocal Microscopy under Endoscopic Ultrasound Guidance. Endosc Ultrasound. 2012 Jul;1(2):80-3. doi: 10.7178/eus.02.005.

ReferenceCitation: Wallace MB, Meining A, Canto MI, Fockens P, Miehlke S, Roesch T, Lightdale CJ, Pohl H, Carr-Locke D, Löhr M, Coron E, Filoche B, Giovannini M, Moreau J, Schmidt C, Kiesslich R. The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract. Aliment Pharmacol Ther. 2010 Mar;31(5):548-52. doi: 10.1111/j.1365-2036.2009.04207.x. Epub 2009 Nov 30.

ReferenceCitation: Becker V, Wallace MB, Fockens P, von Delius S, Woodward TA, Raimondo M, Voermans RP, Meining A. Needle-based confocal endomicroscopy for in vivo histology of intra-abdominal organs: first results in a porcine model (with videos). Gastrointest Endosc. 2010 Jun;71(7):1260-6. doi: 10.1016/j.gie.2010.01.010. Epub 2010 Apr 24.

ReferenceCitation: Khalid A, Brugge W. ACG practice guidelines for the diagnosis and management of neoplastic pancreatic cysts. Am J Gastroenterol. 2007 Oct;102(10):2339-49. Epub 2007 Aug 31. Review.

ReferenceCitation: Bhutani MS. Role of endoscopic ultrasonography in the diagnosis and treatment of cystic tumors of the pancreas. JOP. 2004 Jul;5(4):266-72. Review.

ReferenceCitation: Sahani DV, Kadavigere R, Saokar A, Fernandez-del Castillo C, Brugge WR, Hahn PF. Cystic pancreatic lesions: a simple imaging-based classification system for guiding management. Radiographics. 2005 Nov-Dec;25(6):1471-84. Review.

ReferenceCitation: Palazzo M, Sauvanet A, Gincul R, Borbath I, Vanbiervliet G, Bourdariat R, Lemaistre AI, Pujol B, Caillol F, Palazzo L, Aubert A, Maire F, Buscail L, Giovannini M, Marque S, Napoléon B. Impact of needle-based confocal laser endomicroscopy on the therapeutic management of single pancreatic cystic lesions. Surg Endosc. 2020 Jun;34(6):2532-2540. doi: 10.1007/s00464-019-07062-9. Epub 2019 Aug 13.

ReferenceCitation: Napoleon B, Palazzo M, Lemaistre AI, Caillol F, Palazzo L, Aubert A, Buscail L, Maire F, Morellon BM, Pujol B, Giovannini M. Needle-based confocal laser endomicroscopy of pancreatic cystic lesions: a prospective multicenter validation study in patients with definite diagnosis. Endoscopy. 2019 Sep;51(9):825-835. doi: 10.1055/a-0732-5356. Epub 2018 Oct 22.

ReferenceCitation: Giovannini M, Caillol F, Monges G, Poizat F, Lemaistre AI, Pujol B, Lucidarme D, Palazzo L, Napoléon B. Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy in solid pancreatic masses. Endoscopy. 2016 Oct;48(10):892-8. doi: 10.1055/s-0042-112573. Epub 2016 Aug 30.

ReferenceCitation: Napoléon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Filoche B, Giovannini M. A novel approach to the diagnosis of pancreatic serous cystadenoma: needle-based confocal laser endomicroscopy. Endoscopy. 2015 Jan;47(1):26-32. doi: 10.1055/s-0034-1390693. Epub 2014 Oct 17.

lead_sponsor: Mauna Kea Technologies

location_facility:
Institut Paoli Calmettes
Hôpital Jean Mermoz
Hôpital Saint-Philibert


title: A Phase I Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib (BSI-201) in Multiple Non Operable Brain Metastases

acronym: RAPIBE

summary:
Recent pre-clinical and clinical data have indicated that BSI-201 does not possess characteristics typical of the PARP inhibitor class. Based on the results from in vitro and in vivo studies, this trial aims to evaluate the combination of BSI-201 concomitantly with radiotherapy in patients who present with multiple non operable brain metastases. As radiotherapy is a local treatment targeting only the tumor, and because the molecule BSI-201 has shown no major toxicity against tissues without DNA alterations, the proposed combination is expected to provide tumor-selective therapy and leading to a clinical benefit improvement.

Primary objective is to determine the recommended phase II dose (RP2D) and evaluate acute toxicity (CTC-AE v4.0 grading scale) of concurrent administration of whole brain radiotherapy (WBR) and a small molecule BSI-201 in non operable brain metastases.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility:
AP-HP Hôpital Saint-Louis
Institut Gustave-Roussy
CRLC Val d'Aurelle-Paul Lamarque

intervention_type: Radiation


title: Role of Complement System in Human Allogeneic Haematopoietic Stem Cell Transplantation

summary: Allogeneic haematopoietic stem cell transplantation (HSCT) often remains the only curative treatment for haematological malignancies. The anti-leukaemic effect of allogeneic HSCT, called the GvL (Graf-versus-Leukemia) effect, is often associated to the development of an immune response against healthy recipient cells leading to a graft-versus-host disease (GvHD) in 20 to 70% of allogeneic HSCT. Acute GvHD, that usually targets the skin, the gastrointestinal (GI) tract and the liver, is an important cause of morbidity and mortality after allogeneic HSCT, particularly in the case of GI GvHD. The main goal of the research in the field of allogeneic HSCT is to determine strategies that could decrease the risk of GvHD without affecting the GvL effect. According to GVHD experimental models, it is likely that GvL but not GvHD may occur in the absence of inflammatory signals induced by the transplant-associated conditioning. Based on this hypothesis, we have chosen to analyse the role of Complement system in patients who received allogeneic HSCT. Indeed, Complement system is a major actor of inflammation and in the generation of tissue destruction, both of which are involved in the physiopathology of GVHD. Furthermore, it might be a potential target of some available inhibitory drugs (purified C1-Inhibitor, anti-C5 antibodies) in a preventive or curative manner in such patients. Preliminary data obtained from 34 allografted patients in our institution suggest that Complement activation by the classical pathway is correlated to the occurrence of GI GVHD. The goal of our current project, in order to confirm these preliminary results in a larger series, is to explore Complement system activation in patients who received allogeneic HSCT in three Adult Hematology departments in Paris fot two years and to correlate the biological results to the clinical events occurring after HSCT.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Saint Louis Hospital
Necker Hospital
Saint Antoine Hospital


title: Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room.

lead_sponsor: University Hospital, Montpellier

ReferenceCitation: Milési C, Baleine J, Mura T, Benito-Castro F, Ferragu F, Thiriez G, Thévenot P, Combes C, Carbajal R, Cambonie G. Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2018 May;103(3):F221-F226. doi: 10.1136/archdischild-2017-312808. Epub 2017 Aug 17.

location_facility:
Centre Hospitalier Général
Centre Hospitalier Universitaire

summary:
Anesthesia is rarely used to intubate newborns in delivery room because of the very difficulty of accessing veins. The investigators hypothesized that intranasal administration of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used during neonates' intubation. They are also used intranasally in the absence of venous access-In a pilot study the investigators have demonstrated that sedation with Midazolam was effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS < 4 (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor < 0.2 spike/s.

The investigators hypothesized that intranasal ketamine would increase procedure effectiveness from 67 to 90%.

Main objective: To compare newborns sedation quality as they are sedated either by intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.
Secondary Objectives: To compare intubation quality, hemodynamic and respiratory tolerance, and neurological outcomeat 2 years within the two groups.


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

acronym: IMACORS

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

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

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

location_facility:
CHU Besançon
CHU Dijon
CGFL

intervention_type: Biological


acronym: ORTHOSENS

summary: Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. The clinical study Orthosens will evaluate the efficacy and safety of the Sensory Feedback Ortheses.

lead_sponsor: Thuasne

location_facility: Institut de Chirurgie Orthopédique et Sportive


title: Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers

summary: The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs

lead_sponsor: University Hospital, Lille

location_facility: CHRU de Lille/ Centre d'investigation Clinique


title: S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients

summary: Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in Intensive Care Unit (ICU). That is called " sedation " and aimed to reduce both pain and anxiety and also to allow an effective and atraumatic mechanical ventilation. However, sedation excess and ventilator support excess, both in duration and intensity, are associated with an excess morbidity. Patients usually are systematically sedated after having been intubated. Then, sedation is stopped first before ventilator support is weaning. Several studies shown that rationalized protocols of sedation and ventilation orderings had a beneficial impact on non surgical patients' outcome. Feasibility of these protocols in surgical patients is still unknown. Moreover, no study has evaluated an optimized paired strategy of sedation-ventilation based on the priority setting of ventilation. This priority setting of ventilation should increase patient's comfort in spite of increasing sedatives and analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and intensity of these treatments could improve surgical patients' outcome in ICU.

ReferenceCitation: Chanques G, Conseil M, Roger C, Constantin JM, Prades A, Carr J, Muller L, Jung B, Belafia F, Cissé M, Delay JM, de Jong A, Lefrant JY, Futier E, Mercier G, Molinari N, Jaber S; SOS-Ventilation study investigators. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial. Lancet Respir Med. 2017 Oct;5(10):795-805. doi: 10.1016/S2213-2600(17)30304-1. Epub 2017 Sep 18.

location_facility: Department of Anesthesiology & Critical Care, Estaing University Hospital

location_facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital

location_facility: Department of Anesthesiology & Critical Care, Caremeau University Hospita


title: A Phase 1b Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Subjects With Relapsed Multiple Myeloma

summary: The purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.

ReferenceCitation: Moreau P, Facon T, Touzeau C, Benboubker L, Delain M, Badamo-Dotzis J, Phelps C, Doty C, Smit H, Fourneau N, Forslund A, Hellemans P, Leleu X. Quisinostat, bortezomib, and dexamethasone combination therapy for relapsed multiple myeloma. Leuk Lymphoma. 2016 Jul;57(7):1546-59. doi: 10.3109/10428194.2015.1117611. Epub 2016 Jan 12.

lead_sponsor: Janssen Research & Development, LLC


title: Provision of a Mobile Geriatric Team Extra-Community Hospital in Assessing and Regulating the Hospitalization of Frail Elderly Patients With Complex Medical and Social Situation

acronym: UMG

summary:
The purpose of this study is to demonstrate the effectiveness of the mobile unit to reduce the geriatric hospital inappropriate (especially for emergencies) to 1 month.

The primary endpoint: survival without hospitalization through the emergency inappropriate to 1 month.

ReferenceCitation: Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P. Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998 May 2;316(7141):1348-51.

ReferenceCitation: Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6.

ReferenceCitation: Elkan R, Kendrick D, Dewey M, Hewitt M, Robinson J, Blair M, Williams D, Brummell K. Effectiveness of home based support for older people: systematic review and meta-analysis. BMJ. 2001 Sep 29;323(7315):719-25. Review.

lead_sponsor: University Hospital, Grenoble

location_facility:
CH Annecy
University Hospital of Grenoble
CH Roanne


title: A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors

summary: The purpose of this study was to determine the maximum tolerated dose and the recommended dose of BN80927 in patients with advanced malignant solid tumors.

lead_sponsor: Ipsen

location_facility:
Centre Rene Huguenin
Centre Paul Papin
Centre Eugene Marquis


title: Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus

acronym: VITALUP

summary:
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.

SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).

Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.

Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.

location_facility:
Nathalie Costedoat-Chalumeau
Hopital la Pitie Salpétrière
Chu Pitie Salpetriere


title: Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus

acronym: MagTIN

summary: The objective of the investigators study is to assess conventional repetitive transcranial magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized, double-blind, sham-controlled procedure, with four increasing levels of magnetic "pseudo-dose" has been designed, in order to characterize the effectiveness of rTMS while controlling its safety and tolerability. By combining various rTMS protocols with a twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of therapeutic management.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud

location_facility: Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot

location_facility: Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud


title: Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy

acronym: FORTIS

summary: The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.

ReferenceCitation: Ysebaert L, Larcher M, Compaci G, Oberic L, Sahnes L, Banos A, Araujo C, Sommet A, Laurent G, Despas F. Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia. Ann Hematol. 2019 Apr;98(4):931-939. doi: 10.1007/s00277-019-03631-z. Epub 2019 Feb 18.

lead_sponsor: University Hospital, Toulouse

location_facility:
CH Saint Jean
CHU Purpan
Centre Hospitalier de la côte basque


title: Probiotics Supplementation and Nutritional Benefit in Premature Infants

summary: The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.

ReferenceCitation: Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16.

lead_sponsor: Nestlé

location_facility: Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve

location_facility: Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

location_facility: Service de Nénatologie, Hôpital Femme Mère Enfant

intervention_type: Dietary Supplement


acronym: NOSTRIL

title: Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients

location_facility:
Clinical Investigation center
Lens Hospital
Dunkerque Hospital

summary:
Background :

Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have been shown to influence survival and MUC5B expression in mice model of chronic pulmonary infection.

Method :

To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1, MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study end point will be assessed two times: before randomization and after 60 days of treatment.

Statistical analysis :

Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per protocol.


title: Study of the Natural History of Cerebral White Matter Involvement in Metachromatic Leukodystrophy, Using High-field MRI and Diffusion Tensor Imaging

acronym: HCIT-MLD

summary: High-field MRI and diffusion tensor imaging with 3D reconstruction of the myelin tracks, in combination with multivoxel proton spectroscopy, will allow to precise more accurately the evolution of the white matter lesions in patients affected with Metachromatic Leukodystrophy (particularly in the initial phase of the disease). This will increase the knowledge of the disease and provide new indicators for the selection and evaluation of patients eligible for new therapeutic approaches.

location_facility: Unité de recherche biomédicale, Neurospin, I2BM / DSV / SAC/ CEA,

location_facility: Bâtiment Lavoisier - Unité INSERM U 663,Hôpital Necker Enfants Malades

location_facility: Service de Neurologie Pédiatrique, Hôpital Bicêtre


title: Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)

summary: The primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.

location_facility: Centre Hospitalier Universitaire de Nîmes


title: L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial

summary:
Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.

The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.

The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Caen University Hospital
Lens Hospital
Amiens University Hospital


title: Search a Correlation Between Lipoprotein(a) Rate and TFPI(Tissue Factor Pathway Inhibitor)Activity in Obese Patients With Chest Pain Like Angina

summary:
Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is associated with an increase risk of cardiovascular complications.

Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.

Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .

The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de cardiologie - CHU de Saint-Etienne


title: Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance

summary: The main objective of this study is to determine the rate of healthy surgical margins after tumor resection in transoral robot-assisted surgery for glottic and/or supraglottic early stage (T1-T2) laryngeal cancer.

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: A Phase I Dose Escalation Trial of Once Daily Oral Treatment Using Afatinib (BIBW2992) Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors.

summary:
To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.

To assess the safety of the combination. To investigate the PK characteristics of docetaxel or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess antitumor activity.

ReferenceCitation: Hiret S, Isambert N, Gomez-Roca C, Bennouna J, Sassi M, de Mont-Serrat H, Fan J, Schnell D, Delord JP. Phase I dose-escalation trial of afatinib, an irreversible ErbB family blocker, in combination with gemcitabine or docetaxel in patients with relapsed or refractory solid tumors. Invest New Drugs. 2018 Dec;36(6):1044-1059. doi: 10.1007/s10637-018-0601-1. Epub 2018 May 29.

lead_sponsor: Boehringer Ingelheim

location_facility: 1200.93.33002 Boehringer Ingelheim Investigational Site

location_facility: 1200.93.33003 Boehringer Ingelheim Investigational Site

location_facility: 1200.93.33001 Boehringer Ingelheim Investigational Site


title: Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction

acronym: NASEPT

summary: The aim of this project is to evaluate the safety and efficacy of the biomaterial made of HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this biomaterial will avoid the graft sampling and we expect it to be a good substitute to support the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would confirm previous in vitro and in vivo studies.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'Oto-rhino-laryngologie - Hôpital Dupuytren

location_facility: Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux

location_facility: Service d'Oto-rhino-laryngologie - Clinique St Augustin


title: Phase II Study Evaluating According to the Polymorphism of CYP2D6, the Rate of Biological Response to Treatment With Tamoxifen (TAM) Administered in Pre-operative Situation in Patients With Breast Cancer Non Metastatic HR+

acronym: TAM

summary:
The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.

The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.

primary_purpose: Screening

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancerologie de l'Ouest (ICO)


title: STUDY OF PHASE ID'ACIDE ZOLEDRONIC ASSOCIATED WITH A STRONG DOSE Hypofractionated Radiotherapy in Bone Metastases Vertebral Prostate Adenocarcinoma

acronym: GEMO

summary:
This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high dose irradiation (3 Gy x 9) associated with zoledronic acid.

The administration of zoledronic acid repeat dosages defined under the Authorisation on the Market.

All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at least 48 hours apart each, for a treatment to J1, J3 and J5.

location_facility:
Centre Léon Bérard
Centre René Gauducheau
Centre Paul Papin


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

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

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

lead_sponsor: Eli Lilly and Company

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


title: Auto-immunity and Prognosis of Pulmonary Arterial Hypertension

acronym: Auto-HTAP

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

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

location_facility: Pneumology Department, Antoine Béclère Hospital

location_facility: Internal Medicine Department, Cochin Hospital

location_facility: Internal Medicine Department, Claude Huriez Hospital


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

acronym: AVASTEM

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

lead_sponsor: Institut Paoli-Calmettes

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


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

acronym: CAPSCOL

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

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

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

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

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

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

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

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

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

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

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

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

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

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chru Lille
Hopital Beaujon
Chu Nantes


title: Phase I Dose-escalation, Pharmacokinetic and Pharmacodynamic Study of Debio 0932, a Novel Hsp90-inhibitor, Administered Orally, in Patients With Advanced Solid Tumours or Lymphoma

summary: The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when administered orally, every-other-day or daily during the first 30 days, in patients with solid tumours or lymphoma.

ReferenceCitation: Croce CM. Oncogenes and cancer. N Engl J Med. 2008 Jan 31;358(5):502-11. doi: 10.1056/NEJMra072367. Review.

ReferenceCitation: Workman P, Burrows F, Neckers L, Rosen N. Drugging the cancer chaperone HSP90: combinatorial therapeutic exploitation of oncogene addiction and tumor stress. Ann N Y Acad Sci. 2007 Oct;1113:202-16. Epub 2007 May 18. Review.

ReferenceCitation: Maloney A, Workman P. HSP90 as a new therapeutic target for cancer therapy: the story unfolds. Expert Opin Biol Ther. 2002 Jan;2(1):3-24. Review.

ReferenceCitation: Kamal A, Boehm MF, Burrows FJ. Therapeutic and diagnostic implications of Hsp90 activation. Trends Mol Med. 2004 Jun;10(6):283-90. Review.

ReferenceCitation: Chiosis G, Vilenchik M, Kim J, Solit D. Hsp90: the vulnerable chaperone. Drug Discov Today. 2004 Oct 15;9(20):881-8. Review.

ReferenceCitation: Mosser DD, Morimoto RI. Molecular chaperones and the stress of oncogenesis. Oncogene. 2004 Apr 12;23(16):2907-18.

ReferenceCitation: Obermann WM, Sondermann H, Russo AA, Pavletich NP, Hartl FU. In vivo function of Hsp90 is dependent on ATP binding and ATP hydrolysis. J Cell Biol. 1998 Nov 16;143(4):901-10.

ReferenceCitation: Vilenchik M, Solit D, Basso A, Huezo H, Lucas B, He H, Rosen N, Spampinato C, Modrich P, Chiosis G. Targeting wide-range oncogenic transformation via PU24FCl, a specific inhibitor of tumor Hsp90. Chem Biol. 2004 Jun;11(6):787-97.

ReferenceCitation: Powers MV, Workman P. Targeting of multiple signalling pathways by heat shock protein 90 molecular chaperone inhibitors. Endocr Relat Cancer. 2006 Dec;13 Suppl 1:S125-35. Review.

ReferenceCitation: Banerji U, Judson I, Workman P. The clinical applications of heat shock protein inhibitors in cancer - present and future. Curr Cancer Drug Targets. 2003 Oct;3(5):385-90. Review.

ReferenceCitation: Chiosis G, Lucas B, Huezo H, Solit D, Basso A, Rosen N. Development of purine-scaffold small molecule inhibitors of Hsp90. Curr Cancer Drug Targets. 2003 Oct;3(5):371-6. Review.

ReferenceCitation: Eccles SA, Massey A, Raynaud FI, Sharp SY, Box G, Valenti M, Patterson L, de Haven Brandon A, Gowan S, Boxall F, Aherne W, Rowlands M, Hayes A, Martins V, Urban F, Boxall K, Prodromou C, Pearl L, James K, Matthews TP, Cheung KM, Kalusa A, Jones K, McDonald E, Barril X, Brough PA, Cansfield JE, Dymock B, Drysdale MJ, Finch H, Howes R, Hubbard RE, Surgenor A, Webb P, Wood M, Wright L, Workman P. NVP-AUY922: a novel heat shock protein 90 inhibitor active against xenograft tumor growth, angiogenesis, and metastasis. Cancer Res. 2008 Apr 15;68(8):2850-60. doi: 10.1158/0008-5472.CAN-07-5256.

ReferenceCitation: Chandarlapaty S, Sawai A, Ye Q, Scott A, Silinski M, Huang K, Fadden P, Partdrige J, Hall S, Steed P, Norton L, Rosen N, Solit DB. SNX2112, a synthetic heat shock protein 90 inhibitor, has potent antitumor activity against HER kinase-dependent cancers. Clin Cancer Res. 2008 Jan 1;14(1):240-8. doi: 10.1158/1078-0432.CCR-07-1667.

ReferenceCitation: Böll B, Eltaib F, Reiners KS, von Tresckow B, Tawadros S, Simhadri VR, Burrows FJ, Lundgren K, Hansen HP, Engert A, von Strandmann EP. Heat shock protein 90 inhibitor BIIB021 (CNF2024) depletes NF-kappaB and sensitizes Hodgkin's lymphoma cells for natural killer cell-mediated cytotoxicity. Clin Cancer Res. 2009 Aug 15;15(16):5108-16. doi: 10.1158/1078-0432.CCR-09-0213. Epub 2009 Aug 11.

ReferenceCitation: Abramson JS, Chen W, Juszczynski P, Takahashi H, Neuberg D, Kutok JL, Takeyama K, Shipp MA. The heat shock protein 90 inhibitor IPI-504 induces apoptosis of AKT-dependent diffuse large B-cell lymphomas. Br J Haematol. 2009 Feb;144(3):358-66. doi: 10.1111/j.1365-2141.2008.07484.x. Epub 2008 Nov 13.

ReferenceCitation: Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990 Feb;28(2):72-8.

ReferenceCitation: Isambert N, Delord JP, Soria JC, Hollebecque A, Gomez-Roca C, Purcea D, Rouits E, Belli R, Fumoleau P. Debio0932, a second-generation oral heat shock protein (HSP) inhibitor, in patients with advanced cancer-results of a first-in-man dose-escalation study with a fixed-dose extension phase. Ann Oncol. 2015 May;26(5):1005-1011. doi: 10.1093/annonc/mdv031. Epub 2015 Feb 2.

lead_sponsor: Debiopharm International SA

location_facility:
Institut Claudius Regaud
Centre Georges-François Leclerc
Institut Gustave Roussy


acronym: DRAG

summary: Objective: This research agreement brings together French and Canadian teams of scientists, HIV testing centers and community based partners. The aim is to explore the feasibility and limitations of offering community based rapid HIV testing to men who have sex with men (MSM).

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

location_facility: CDAG (Free Anonymous Screening Consultation) center


acronym: Immunogenicity and Safety of a Vaccine against Influenza (2010-2011 NH season, intramuscular route)

title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route)

lead_sponsor: Sanofi Pasteur, a Sanofi Company

summary:
The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96

Objectives:

To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups
To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups


title: The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

acronym: VAPARA

summary: The purpose of this study is to verify and validate the intrinsic diagnostic value in terms of sensitivity and specificity of proteomic profiles determined during a pre-study for discriminating between allergy related asthma and allergy related rhinitis.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Assistance Publique - Hopitaux de Marseille


title: An Open-Label Dose Escalation Safety Study of PVS-10200 for the Treatment of Restenosis in Patients Undergoing Minimally Invasive Peripheral Revascularization (TRIUMPH)

acronym: TRIUMPH

summary: The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD).

ReferenceCitation: Sevestre MA, Larghero J, Castier Y, Nugent HM, Visonneau S, Alsac JM. Pilot safety study of perivascular injection of tissue-engineered allogeneic aortic endothelial cells in patients undergoing minimally invasive peripheral revascularization. J Vasc Surg. 2014 Jun;59(6):1597-606. doi: 10.1016/j.jvs.2014.01.014. Epub 2014 Mar 7.

lead_sponsor: Shire

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Phase IV Multicentric Study, 30 Patients Suffering of Meibomian Glands Dysfunction.

acronym: ESPOIR

summary:
Multicentric study, open label, uncontrolled phase IV in 30 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.

lead_sponsor: Laboratoires Thea

location_facility:
HÃ´pital Gabriel Montpied
C.H.N.O des XV-XX
Hôpital Bichat - Claude Bernard


title: Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children

acronym: BUMEA

summary: The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism

ReferenceCitation: Lemonnier E, Degrez C, Phelep M, Tyzio R, Josse F, Grandgeorge M, Hadjikhani N, Ben-Ari Y. A randomised controlled trial of bumetanide in the treatment of autism in children. Transl Psychiatry. 2012 Dec 11;2:e202. doi: 10.1038/tp.2012.124.

lead_sponsor: University Hospital, Brest

location_facility: Lemonnier DUPIN Chevreuil


title: Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT).

summary: The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.

lead_sponsor: University Hospital, Caen

location_facility:
CHU Saint Louis Dept of Hematology
CHU Henri Mondor
CHU CAEN Dept of Hematology


title: Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

location_facility:
Chu de Saint-Etienne
Assistance Publique - Hôpitaux de Paris
Clinique de la Mutualiste

summary: After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare.


title: Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

summary: The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).

lead_sponsor: Centre Oscar Lambret

location_facility:
Institut Bergonié
Centre Oscar Lambret
Centre Léon Bérard


title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Lidocaine

acronym: Propofols

summary: The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.

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.

lead_sponsor: Hopital Foch

location_facility: Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré


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

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

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

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

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

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

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


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

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

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

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

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon


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

acronym: DIPROCOL

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

location_facility:
Centre Oscar Lambret
Centre Hospitalier Régional
Centre Hospitalier Regional


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
Institut Curie


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

acronym: EPIALHICE B

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

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

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

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU Montpellier
CHU Nice
CHU Toulouse


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

acronym: Drone-Curare

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

location_facility:
CHU Besançon
Hôpital Foch
Institut Paoli-Calmette