title: Patient Dyspnea Under Veno-arterial Extracorporeal Circulation: Quality, Mechanisms and Sensitivity to Increased Sweep Gas Flow Through the Membrane Lung and Positive Expiratory Pressure

summary:
Rationale: Patients with severe heart failure increasingly benefit from extracorporeal circulatory assistance (Extracorporeal Membrane Oxygenation - ECMO) that completely replaces the function of the heart and is in addition to mechanical ventilation (veno-arterial ECMO). In clinical practice, some of these patients have been found to be dyspneic, although circulatory assistance ensures satisfactory hematosis. Indeed, nearly half of the patients undergoing mechanical ventilation in intensive care have a generally intense dyspnea. In addition to the immediate discomfort caused by dyspnea, which can be assimilated to pain, this symptom is associated with a prolonged duration of mechanical ventilation and contributes to the genesis of neuropsychological sequelae of resuscitation such as post-traumatic stress syndrome.

Objectives :

To study the effectiveness and impact of an increase in ECMO sweep gas flow through the membrane lung or positive tele-expiratory pressure (PEP) on dyspnea in patients under ECMO.
To understand the mechanism involved in this relief of dyspnea. Methods: in 30 patients of Intensive Care Unit, dyspnea will be evaluated by psychophysiological scales and scores as well as by neurophysiological tools (electromyography of inspiratory muscles) during sweep gas flow through the membrane lung incrementation and PEP increase.

Ethical framework: Changes in ventilation parameters and ECMO will be performed in the usual manner, without additional or unusual diagnostic, treatment or monitoring procedures.

Expected results and outlook: the investigators hypothesize that half of the patients on veno-arterial ECMO have dyspnea related to pulmonary edema. Therefore, an increase in PEP would alleviate this dyspnea. The investigators hypothesize that by using a relief method related to increased sweep gas flow through the membrane lung, the investigators can reduce the discomfort without inducing any associated complication.

This study will improve the knowledge of the mechanisms determining dyspnea in patients under ECMO and the principle of therapeutic strategy to improve it.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière


title: Hypophosphatemia In Infants With Severe Bronchiolitis: Prevalence And Risk Factors

summary: Bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. Hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. Our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Hopital Femme Mere Enfant - Groupement Hospitalier Est

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Contribution of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) to Optimize Maternal Pre-oxygenation and Anaesthetic Preparation Time for General Anaesthesia for Urgent Caesarean Section A Prospective Experimental Study on Healthy Volunteers.

acronym: PREOXCE

summary: The main objective of this study is to determine if the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) can reduce by 90 seconds the time between the entry into the operating room of the volunteer and the moment when the anaesthetic drugs are ready and when the Oxygen Reserve Index has reached a plateau value for more than 10 seconds, a moment which would therefore allow the induction of general anaesthesia, compared to the pre-oxygenation with the face mask applied by the anaesthetist alone in charge of anaesthesia.

study_start_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

intervention_type: Procedure


title: Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts

acronym: VAC-WARTS

summary: Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. For the palms and soles, HPV 2 has been the most frequently found but HPV 1, 4, 27, and 57 have also been described. Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.

status: Not yet recruiting

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: VASCular Impact of Angiogenic Treatment in Patients With Advanced Colorectal Cancer

acronym: VASCATAQ

summary:
Antiangiogenic treatments are used in many tumor locations such as metastatic colorectal cancer (mCRC) with a significant improvement in carcinological results on overall survival and / or progression-free survival. However, their use is characterized by an increase in side effects and in particular cardiovascular effects such as high blood pressure (hypertension). One of the main classes of antiangiogens used in this indication is that of monoclonal antibodies, the leader of which is bevacizumab (Avastin®, Roche, Bale, Switzerland). Bevacizumab works by inhibiting endothelial vascular growth factor-dependent neoangiogenesis (vascular endothelial growth factor VEGF). In the reference studies, the inhibition of VEGF, whether extracellular (monoclonal antibody directed against VEGFA) or intracellular (receptor inhibitors with tyrosine kinase activity), induces hypertension of all grades, observed in 25% to 40 % of patients including 8 to 17% of severe grades (≥ grade 3 NCI-CTCAE). In terms of pathophysiology, inhibition of VEGFA results in a decrease in the availability of nitric oxide (NO) at the endothelial level and the appearance of arteriolar rarefaction. This induces an increase in peripheral resistance responsible ultimately for an increase in blood pressure. The occurrence of hypertension induced by anti-VEGF treatment seems to be predictive of the carcinological response in certain oncological situations such as metastatic breast cancer9, glioblastoma and mRCC. Furthermore, it has also been shown that there is an early attack on the elastic conductance arteries (branches of the aorta and its main ones) characterized by an increase in their rigidity in patients exposed to a VEGF receptor inhibitor with tyrosine activity. kinase or bevacizumab. This increase, whose poor prognostic impact is known at the cardiovascular level is largely independent of the rise in blood pressure and reflects a direct toxicity of treatments at the level of the artery wall. This increase in rigidity, refused when the pressure rises, would be predictive of a low carcinological response rate at 6 months. However, these data are based on populations that are heterogeneous in terms of carcinology and the position prior to or concomitant with other antineoplastic treatments.

In this context, the evaluation of arterial stiffness in the same patient population would make it possible to better define the involvement of the conductive arteries in a clearly defined clinical situation. Joint measurements of the plasma concentration of the treatment as well as those of factors derived from the endothelium and circulating tumor markers which, to our knowledge, have never been carried out in these patients, would make it possible to better specify the mechanisms of involvement and the links between exposure, arterial toxicity and carcinologic efficacy of bevacizumab. Of course, in order to assess more precisely the inherent impact of chemotherapy on the conductance arteries, the evolution of arterial stiffness must take into account the possible effects in patients receiving, for essentially clinical and biological reasons, systemic treatment without antiangiogenic.

lead_sponsor: University Hospital, Rouen

intervention_type: Drug


title: Statement of Care of Anemia in Delivering Patients at Nord Franche-Comte Hospital

acronym: ANEMIA

summary: Anemia is a common pregnancy condition that has multiple origins. Its frequency and severity seem to be increasing, despite the existing management recommendations and the awareness of health professionals. The objective of this study is to make a statement of this pathology within our establishment, to evaluate the proportion of patients presenting this pathology and to highlight possible risk factors.

time_perspective: Cross-Sectional

lead_sponsor: Hopital Nord Franche-Comte

intervention_type: Other


title: Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC)

summary: This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms

design_allocation: Non-Randomized

lead_sponsor: InflaRx GmbH

lead_sponsor_type: industriel


title: Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years : a Multicentre Controlled Cross-sectional Study

acronym: QoLCHD

summary: Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Phase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum

acronym: PIPACOVA

summary:
Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks).

The primary objective of the study is to determine the maximum tolerated dose (MDT).

During cycle 1, limiting dose toxicity must be collected in real time. Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1.

The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial.

Secondary objectives are :

to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy
to describe the pharmacokinetic of the PIPAC chemotherapy
to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment
and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous).

At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized..

In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.


title: Study of Macrophage Function and of the GM-CSF Signaling Pathway in Alveolar Proteinosis by Mutations of the MARS Gene

acronym: MacroMARS

summary:
Mutations in the MARS gene encoding methionyl-tRNA synthetase are responsible for a genetic form of alveolar proteinosis (PAP), but the pathophysiological mechanisms of the respiratory phenotype are not known.

The main hypothesis is that the PAP phenotype in these patients is secondary to a defective clearance of the surfactant by the alveolar macrophages.

The main objective of the study is to study the clearance capacity of lipoproteinaceous material by macrophages of patients with MARS related PAP. This will be investigate in cultured macrophages derived from peripheral blood monocytes of patients (patients with MARS related PAP) and controls (patients without MARS related PAP).

time_perspective: Prospective


title: Pharmaceutical Consultation and Exchange Between the Pharmacy and the Hospital

acronym: EPHET

summary: Investigators hypothesize that the implementation of a hospital pharmacy consultation and the transmission of its report to pharmacies may improve knowledge, adherence and encourage the development of pharmacist medication reviews. A before-and-after study of the implementation of pharmaceutical consultations will allow the investigators to evaluate the validity of the hypothesis.

intervention_type: Behavioral


status: Completed

lead_sponsor: Sanofi Pasteur, a Sanofi Company

enrollment_type: Actual

primary_purpose: Prevention

acronym: Open, phase II trial. 200 subjects aged 18 to 60 years will receive the non-adjuvanted vaccine

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects

summary:
This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.

The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

status_simplified: Completed


title: Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment

acronym: MASI

summary:
Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.

The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.

The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)

ReferenceType: background

ReferenceCitation: Donnelly LF, Bisset GS 3rd. Airway compression in children with abnormal thoracic configuration. Radiology. 1998 Feb;206(2):323-6.

ReferenceCitation: Dubousset J, Charpak G, Skalli W, de Guise J, Kalifa G, Wicart P. [Skeletal and spinal imaging with EOS system]. Arch Pediatr. 2008 Jun;15(5):665-6. doi: 10.1016/S0929-693X(08)71868-2. French.

ReferenceCitation: Heary RF, Bono CM, Kumar S. Bracing for scoliosis. Neurosurgery. 2008 Sep;63(3 Suppl):125-30. doi: 10.1227/01.NEU.0000320387.93907.97. Review.

ReferenceCitation: Jones RS, Kennedy JD, Hasham F, Owen R, Taylor JF. Mechanical inefficiency of the thoracic cage in scoliosis. Thorax. 1981 Jun;36(6):456-61.

ReferenceCitation: Margonato V, Fronte F, Rainero G, Merati G, Veicsteinas A. Effects of short term cast wearing on respiratory and cardiac responses to submaximal and maximal exercise in adolescents with idiopathic scoliosis. Eura Medicophys. 2005 Jun;41(2):135-40.

lead_sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

location_facility: Ecole Nationale Supérieure des Arts et Metiers


title: Neurotrophins Implications in Primary Sjögren Syndrome

acronym: Neuro-SGSp

summary:
Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF " Nerve Growth Factor ", BDNF " Brain-Derived Neurotrophic Factor " and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific "neuro-immunomodulation" through these neuropeptides.

The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.

lead_sponsor: University Hospital, Limoges

location_facility:
Opthalmologie
Médecine Interne


title: Evaluation of Muscle StO2 as a Prognostic Factor After Out of Hospital Cardiac Arrest

summary: Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after return to spontaneous circulation. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the exploration of microvascular function in human. Muscle StO2 is a technique allowing the assessment of microvascular function non-invasively. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.

status: Unknown status

lead_sponsor: Department of Clinical Research and Innovation

location_facility:
CHU de Nice Hôpital Saint Roch
CHU de Nice -Hôpital l'Archet

status_simplified: Unknown


title: Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)

acronym: KILLSLEEP

summary: Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because of conflicts between physiological needs and social or professional activities, it is necessary to develop affordable countermeasure to sleepiness. In real-life driving studies, nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect of caffeine is quick but brief and varies between individuals. There is a need for more knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic light (blue light) decreases subjective sleepiness and improves performances. One objective of this project is to investigate whether blue light exposure during driving would be useful in a real driving situation when sleepiness becomes acute. Owing to the fact that our knowledge of the effects of exercise on driving is very sparse and to the absolutely need to standardize the bouts of exercise that will be applied to the subjects. One objective of the present study will be to investigate in a simulator study the effects of a bout of moderate exercise on participants driving ability when sleepiness becomes acute. Nocturnal neurobehavioral performance varies widely between individuals and only certain subjects seem significantly affected by sleep loss. It is of interest to find biological markers for sleep drive to identify vulnerable drivers to sleep deprivation or to identify responders to sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to determine individual differences (genetic, hormonal and cognitive) in the impairment of driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and coffee).

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Taillard J, Capelli A, Sagaspe P, Anund A, Akerstedt T, Philip P. In-car nocturnal blue light exposure improves motorway driving: a randomized controlled trial. PLoS One. 2012;7(10):e46750. doi: 10.1371/journal.pone.0046750. Epub 2012 Oct 19.

family: Taillard

full_name: Jacques Taillard

given: Jacques

sequence: first

family: Capelli

full_name: Aurore Capelli

given: Aurore

sequence: additional

family: Sagaspe

full_name: Patricia Sagaspe

given: Patricia

family: Anund

full_name: Anna Anund

given: Anna

family: Akerstedt

full_name: Torbjorn Akerstedt

given: Torbjorn

family: Philip

full_name: Pierre Philip

given: Pierre

bso_classification: Biology (fond.)

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLoS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: In-Car Nocturnal Blue Light Exposure Improves Motorway Driving: A Randomized Controlled Trial

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux Groupe Hospitalier Pellegrin


title: Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis

acronym: IQUALYSEP

summary: Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis

primary_purpose: Health Services Research

lead_sponsor: Rennes University Hospital

location_facility:
CHU Rennes
CHU Cavale Blanche


title: The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study

summary:
The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect.

Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid arthritis.

Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and ultrasonography synovitis, 45% of cases with synovial activity.

To our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression.

On the other hand, no studies with extremity dedicated RMI in patients with remission are reported.

In this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated MRI synovitis the structural radiographic progression at one year.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Rheumatology Department, Nice University Hospital


title: Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease

acronym: NAVASYNC

summary: NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).

primary_purpose: Supportive Care

lead_sponsor: Hôpital Européen Marseille

location_facility:
Hopital Paul Desbief
Fondation Hôpital Ambroise Paré


title: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

acronym: IMMUTRI

summary: The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.

ReferenceCitation: Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3.

lead_sponsor: Institut Jerome Lejeune

location_facility: Laboratoire d'Immunologie Biologique (Unité INSERM U580)


title: Pilot Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First Line Treatment of Hormone Independent Metastatic Prostate Cancer

acronym: PROTAXY

summary: RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer.

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Jean Perrin
Institut Jean Godinot

intervention_type: Dietary Supplement


title: Individual and Environmental Risk Factors of Unplanned Admissions of Elderly : RIEHO Inception Cohort

acronym: RIEHO

summary: The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution.

location_facility: Service de Court Séjour Gériatrique, CHU DE REIMS, HOPITAL MAISON-BLANCHE


title: Anatomo-functional Determinants of Cognitive Impairment After Acute Coronary Syndrome: A Brain MRI and Cerebral Perfusion Scintigraphy Study

acronym: COSCA

summary: The general purpose of the present pathophysiological study is to investigate the relation between cognitive impairment observed after an acute coronary syndrome and the presence of cerebral anatomo-functional abnormalities. This study will improve the investigators' understanding of the disease and will help in early diagnosis and prevention of vascular dementia in this population.

location_facility: Hôpital Cardiologique du Haut-Lévêque (CEPTA)


title: Identification of Genes Involved in the Pathogenesis of Gliomas by Transcriptome Analysis

summary:
RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue samples from patients with glioma or other brain tumors.

location_facility:
CHU Montpellier
Clinique Gui de Chauliac


title: Study of the Effect of the Chronic Electric Stimulation of the Hypothalamus/Fornix on Memory Impairment in Alzheimer Disease.

summary:
Alzheimer's Disease (AD) is the most common cause of dementia. Today no treatment had shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus suggests that neuromodulation of circuits involved in memory processes may have therapeutic implications in AD patients with memory decline.

The primary objectives of this prospective, non-controlled, pilot study are to assess the feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and specific impairment of episodic memory will be included in a 2-year period. The evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated using numerous cognitive and memory testing including classical instrument used in AD clinical trials. Changes in behavioral scales, and changes in hypothalamic functions (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.

The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to AD patient the possibility to slow down/stabilize their symptoms, which no other treatment can currently offer, and to increase their quality of life.

location_facility: Service de Neurochirurgie Hôpital Universitaire de Pasteur

intervention_type: Device


acronym: Immunogenicity and Safety of a Vaccine Against Influenza (2009-2010 Northern Hemisphere Season)

title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route)

summary:
This study is in support of the annual application for the variation of the vaccine strains for a marketing authorisation.

Objectives:

To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.
To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.


title: Evolution of Pulmonary Capillary Blood Volume (Vc) in Patients After a First Episode of Pulmonary Embolism.

acronym: VcEP

summary: The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Department of Medicine and Therapeutic, CHU Saint-Etienne

location_facility: Departement of pneumology, CHU Saint-Etienne


title: IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS

acronym: IntensVIH

summary:
To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r).

To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by:

residual plasma replication between 0 and 50 copies/ml
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL).
proviral HIV DNA levels in PBMC and RL.

ReferenceCitation: Lafeuillade A, Assi A, Poggi C, Bresson-Cuquemelle C, Jullian E, Tamalet C. Failure of combined antiretroviral therapy intensification with maraviroc and raltegravir in chronically HIV-1 infected patients to reduce the viral reservoir: the IntensHIV randomized trial. AIDS Res Ther. 2014 Oct 7;11(1):33. doi: 10.1186/1742-6405-11-33. eCollection 2014.

family: Lafeuillade

full_name: Alain Lafeuillade

given: Alain

family: Assi

full_name: Assi Assi

given: Assi

family: Poggi

full_name: Cécile Poggi

given: Cécile

family: Bresson-Cuquemelle

full_name: Caroline Bresson-Cuquemelle

given: Caroline

family: Jullian

full_name: Eric Jullian

given: Eric

family: Tamalet

full_name: Catherine Tamalet

given: Catherine

bso_classification: Medical research

currency_apc_doaj: GBP

journal_name: AIDS Research and Therapy

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur mer


title: Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers

summary: The primary objective of this study is to assess the sensitivity and specificity of a MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow up visit.

lead_sponsor: University Hospital, Grenoble

location_facility: Service de Diabétologie du Pr Halimi, CHU Grenoble


title: Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing

summary:
This study is a clinical, multicentric, randomised open trial. The objective is to evaluate the efficiency, in terms of wound healing speed, of peroperative application of autologous platelets gel versus standardized wound dressing. The wound Healing model used in this study is the " open palm " surgical treatment of Dupuytren's disease.

Dupuytren's disease is a fibroproliferative disease of the palmar and digital fascia of the hand that may lead to a fixed flexion contracture of the fingers.

The main indication for surgery is the loss of finger extension. In some cases of palmar Dupuytren's disease the surgical removal of diseased tissues may lead to a cutaneous loss of substance (" open palm technique "). This loss of substance is treated using vaseline dressing and the wound healing is obtained in 4 weeks.

Autologous platelets gel (Platelet Rich Fibrin) is obtained from the patient's own blood. Some recent studies have shown that it speeds up the wound healing and enhances the quality of the scar.

PRF belongs to a new generation of autologous platelet gel that are easily obtained after centrifugation of patient's own blood.

The Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor (VEGF).

The study will be running on 60 days, starting from the operation day. The wound healing evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.

The inclusion criteria are : age over 18, Dupuytren's disease with an indication of surgical treatment using the open palm technique, patients having signed the agreement form.

80 patients will be included in the study and divided into 2 groups . The first group of patients will receive PRF and the other group will receive vaseline dressings.

The speed and the quality of wound healing will be compared.We will also compare the number of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain during the dressings' change and the bleeding of the palmar wound.

For the wound healing speed , a difference of 7 days between the two groups will be considered as statistically significant.

Statistical analysis will be achieved using Chi2 test and Logrank test.

ReferenceCitation: Chignon-Sicard B, Georgiou CA, Fontas E, David S, Dumas P, Ihrai T, Lebreton E. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial. Plast Reconstr Surg. 2012 Dec;130(6):819e-829e. doi: 10.1097/PRS.0b013e31826d1711.

family: Chignon-Sicard

full_name: Bérengère Chignon-Sicard

given: Bérengère

family: Georgiou

full_name: Charalambos A. Georgiou

given: Charalambos A.

family: Fontas

full_name: Eric Fontas

family: David

full_name: Sylvain David

given: Sylvain

family: Dumas

full_name: Pierre Dumas

family: Ihrai

full_name: Tarik Ihrai

given: Tarik

family: Lebreton

full_name: Elisabeth Lebreton

given: Elisabeth

journal_name: Plastic and Reconstructive Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Efficacy of Leukocyte- and Platelet-Rich Fibrin in Wound Healing

location_facility: Centre Hospitalier Universitaire de Nice Hôpital de Cimiez


title: Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.

acronym: ECP

summary:
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson] according to the following schedule:

Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.

Total = 8 ECP after transplantation.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Santé - Etablissement Français du Sang (EFS)

location_facility: Hôpital Edouard Herriot, Service d'Hématologie


title: Age Influence on the Modifications of the Oral, Pharyngeal and Laryngeal Axis Alignment in Children Induced by Head Extension: an MRI Study

summary:
In pediatric anesthesia and in pediatric intensive care, tracheal intubation is one of the most important procedure. To achieve this procedure as fast as possible and in is best conditions, the physician should choose the head posture which a priori will enable at first the best glottic visualisation during laryngoscopy, and at second will facilitate the route of the tube from the larynx to the trachea.

Tracheal intubation is a procedure used for years, and many textbooks recommendations on the best head posture for tracheal intubation in paediatrics have been made. Briefly summarized, depending on the age of the child, the head should (or not) be slightly extended, and a pillow should (or not) be positioned under the occiput. These recommendations are questionable for three majors reasons:

despite an apparent consensus, some recommendations are quite different.
none are based on anatomical nor clinical studies
if for all of them, the age of the child is considered as critical point, but children are only grossly categorized in three categories (newborn, infants and old children). And the clinician has no way, facing a child, to make his choice between dichotomic attitudes.

Actually, the responses to these questions should need rigourous clinical studies on laryngoscopy, hard to design and very difficult to make. P.Adnet et coll. (Anesthesiology 2001) showed that an anatomical study with resonance magnetic imaging (MRI) can bring indirect but strong evidence and can be a first step leading to clinical studies. Many children need MRI study for different reasons, and it is fast and easy to get during their examination additional images of the superior airway.

In their unit, the investigators are experienced in this kind of study, as they recently published (Pediatric Anesthesia 2008) an MRI study demonstrating that in children, head extension improves the alignment of the visualisation axis on the laryngeal axis, but worsens the alignment of the pharyngeal axis on the laryngeal axis. However, patients included in their study were in major part infants, so the influence of the age could not be properly analyzed. Morevover, this study suffered of two main limitations, the lack of standardisation of head postures, and that a laryngeal mask the children, who were on general anesthesia (required for the MRI examination) were made using a laryngeal mask (as it was at this time the standard in their institution).

The investigators propose an MRI study of the influence of age on the consequences of head extension on the anatomic axes of the superior airway in children, with a prospective stratified on age study. Several modifications and improvement in the design of this study would diminished the limitations of the first study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hopitaux de Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Phase II Study Evaluating the Effectiveness of the Exemestane (Aromasin) With Tamoxifen on the Rate of Clinical Response Menopausal in Patients With Locally Advanced Breast Tumors

acronym: TAMARO

summary: This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.

lead_sponsor: Institut Claudius Regaud

location_facility:
CHU de Toulouse Rangueil
Institut Claudius Regaud


title: Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE

acronym: UVEXATE

summary: The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.

status: Terminated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Avicenne - Service de Médecine Interne


title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.

acronym: AUTOSOP

summary: The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil Attention Transport). It will stimulate data acquisition in technological research to better understand the difference between real and simulated driving

primary_purpose: Diagnostic

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ReferenceCitation: Sangal RB, Thomas L, Mitler MM. Maintenance of wakefulness test and multiple sleep latency test. Measurement of different abilities in patients with sleep disorders. Chest. 1992 Apr;101(4):898-902.

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location_facility:
GENNPHASS - CHU de Bordeaux
AP-HP - Hôpital de l'Hôtel-Dieu


title: Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR

summary: To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine

lead_sponsor: Boehringer Ingelheim

location_facility: 1200.69.3302 Boehringer Ingelheim Investigational Site

location_facility: 1200.69.3301 Boehringer Ingelheim Investigational Site


type: Registry Identifier

title: Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology

summary:
RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.

PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.

lead_sponsor: Centre Oscar Lambret

location_facility:
Laboratoire URECA
Centre Oscar Lambret


title: Potential Role for Nocturnal PtcCO2 Monitoring in the Close Follow up of ALS Patients.

summary:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons, with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS and remains the main prognostic factor. Timing and rate of progression of this respiratory muscle involvement is also highly variable among individuals.

Respiratory manifestations justify a careful follow up including clinical evaluation, pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment has been clearly demonstrated in ALS, although several cut off values have been published. The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the optimal criteria for its initiation remain debated .

The 1999 consensus for NIV selected classical criteria to consider NIV in patients with respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 > 45 mmHg), nocturnal SaO2 < 89 % more than 5 consecutive minutes and for progressive neuromuscular disorders (NMD) (mainly ALS), a vital capacity (VC) < 50 % pred or a PImax < 60 cmH2O.

Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The prevalence of sleep apnea ranges from 16 % to 76 %.

Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal hypoventilation. The technique is well validated in different settings. Its use in neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To our knowledge, this technique has not been specifically assessed in ALS. There is a potential role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close respiratory follow up of ALS patients is essential to determine the optimal timing of NIV, avoiding the occurence of unexpected acute respiratory failure.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Pôle des maladies respiratoires et service EFR- Centre hospitalier Regional Universitaire


title: Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients

acronym: Nutri-PA

summary:
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.

The primary endpoint is the outcome of fat-free mass measured by multiple frequence bio-impedance analysis.

lead_sponsor: University Hospital, Rouen

location_facility:
UHRouen
Centre Hospitalier de Dieppe


title: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.

acronym: READ

summary: The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.

lead_sponsor: University Hospital, Caen

location_facility:
Centre Hospitalier de la Côte Fleurie
William Harvey Center


title: Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome

summary:
Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the upper airway. However the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with minimal pressure.

Different models of autoCPAP function with different signals and event detection algorithms with different modes of reaction to events. These machines are marketed with CE certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. These machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. Thus these bench tests need to be supplemented by clinical studies. The investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. We develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. These clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. The perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.

location_facility: Service explorations fonctionnelles - Hopital La Miletrie


title: Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis.

acronym: DTP

summary:
The purpose of this study is to compare the efficacy of 5 days versus 10 days treatment duration in uncomplicated acute pyelonephritis.

Acute pyelonephritis is a common disease and the treatment duration is not found on scientific evidence. If a short treatment is equal to standard duration, it will possible to shortening antibiotherapy with ecologic and economic advantage.

location_facility:
University hospital of Garches
university hospital of TOURS


title: Damage to DNA Caused by UV-A Irradiation: Photochemical Mechanism and Cutaneous Parameters Involved in the Formation of Cyclobutane Pyrimidine Dimers

acronym: DIMUVA

summary: The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.

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ReferenceCitation: Melnikova VO, Ananthaswamy HN. Cellular and molecular events leading to the development of skin cancer. Mutat Res. 2005 Apr 1;571(1-2):91-106. Review.

ReferenceCitation: Cadet J, Sage E, Douki T. Ultraviolet radiation-mediated damage to cellular DNA. Mutat Res. 2005 Apr 1;571(1-2):3-17. Epub 2005 Jan 26. Review.

ReferenceCitation: Douki T, Reynaud-Angelin A, Cadet J, Sage E. Bipyrimidine photoproducts rather than oxidative lesions are the main type of DNA damage involved in the genotoxic effect of solar UVA radiation. Biochemistry. 2003 Aug 5;42(30):9221-6.

ReferenceCitation: Dumaz N, Drougard C, Sarasin A, Daya-Grosjean L. Specific UV-induced mutation spectrum in the p53 gene of skin tumors from DNA-repair-deficient xeroderma pigmentosum patients. Proc Natl Acad Sci U S A. 1993 Nov 15;90(22):10529-33.

location_facility: Centre d'investigation Clinique ,University Hospital Grenoble

location_facility: Department of Dermatology, University Hospital Grenoble

intervention_type: Radiation


title: Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

acronym: DARTAGNAN

summary: Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.

lead_sponsor: Association Pour La Promotion A Tours De La Reanimation Medicale

location_facility: Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU

location_facility: Service de réanimation médicale. Hôpital La Source. CH Orléans


title: Effects of Parenteral L-carnitine Supplementation in Premature Neonates

acronym: CarniPrema

summary:
Background: Carnitine is the essential cofactor for various enzyme activities of human metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain fatty acids as acylcarnitine esters across the inner mitochondrial membrane for Beta-oxidation and energy production. Intracellular carnitine deficiency induces an impairment of long-chain fatty acid oxidation. In human, approximately 75% of carnitine comes from the diet and 25% from endogenous liver synthesis. In the neonatal period, more specifically in the premature, liver synthesis capacity is reduced because of immaturity of the biosynthetic pathway, and carnitine levels are related to exogenous sources. Traditionally, carnitine is not added to parenteral nutrition. Indeed, without enteral feeds and carnitine supplementation of parenteral nutrition, preterm infants' plasma carnitine levels fall during the first weeks of life, particularly in subjects requiring a prolonged exclusive parenteral nutrition. The potential deleterious role of carnitine deficiency has not been clearly demonstrated in these infants. However, most patients with primary carnitine deficiency, a genetic defect of carnitine transport inducing a severe carnitine deficiency, commonly develop liver symptoms (encompassing visceral steatosis, hyperammonemia and recurrent hypoketotic hypoglycemias) and/or cardiomyopathy and myopathy. In these latter patients, carnitine supplementation improves all the symptoms.

Hypothesis: Carnitine deficiency of the premature and very low birth weight infants may be one of the factors involved in the liver disease frequently associated with prolonged parenteral nutrition, and may have deleterious effects on cardiac and muscle metabolism and functions.

Aims: To demonstrate beneficial effects of parenteral carnitine supplementation in premature neonates for liver, heart and muscle metabolism and functions.

Study Type: Multicentric prospective and randomised study

Subjects: Premature and very low birth weight neonates, defined by gestational age minor or equal to 28 weeks and/or birth weight minor or equal to 1000 grams, 80 subjects will be enrolled during 2.5 years

Interventions: Arm 1 (experimental): parenteral carnitine supplementation (9 ± 1 mg/kg/d), from day 4, until than enteral nutrition provides sufficient carnitine source; Arm 2 (Placebo comparator): parenteral supplementation with an equivalent volume of sterile water.

lead_sponsor: University Hospital, Tours

location_facility: Hôpital Clocheville, University Hospital, Tours


title: Efficacy of Median Nerve Block Performed Using Echographic Guidance

summary: Observational study of the efficacy of median nerve blocks performed using echographic guidance in patients presenting with or without carpal tunnel syndrome.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Hôpital Privé de l'Ouest Parisien


title: Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine

acronym: MOH-PET

summary:
Medication Overuse Headache (MOH) is an illness affecting about 1,5 % of the general population. It is characterized by chronic headache occurring for at least 15 days a month, by a use of antimigraine drugs during at least 3 months for more than 10 days a month (for ergots, triptans, opiate derivates and combined analgesics) or for more than 15 days a month (for simple analgesics). The chronic headache must have occurred during the period of antimigraine drug abuse and the headache must have returned to its episodical pattern after withdrawal of antimigraine drugs. But, about 50% of the MOH patients will relapse during the first year following the antimigraine drugs withdrawal.

The pathophysiology of MOH is still largely unknown, and the role of antimigraine drug abuse in the transformation from migraine through MOH is not fully understood.

ReferenceCitation: Meyer M, Di Scala G, Edde M, Dilharreguy B, Radat F, Allard M, Chanraud S. Brain structural investigation and hippocampal tractography in medication overuse headache: a native space analysis. Behav Brain Funct. 2017 Apr 8;13(1):6. doi: 10.1186/s12993-017-0124-5.

apc_source: openAPC

family: Meyer

full_name: M. Meyer

given: M.

family: Di Scala

full_name: G. Di Scala

given: G.

family: Edde

full_name: M. Edde

family: Dilharreguy

full_name: B. Dilharreguy

given: B.

family: Radat

full_name: F. Radat

given: F.

family: Allard

full_name: M. Allard

family: Chanraud

full_name: S. Chanraud

given: S.

journal_name: Behavioral and Brain Functions

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur

location_facility: C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire


title: Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery

summary:
Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment)

Primary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand)

ReferenceCitation: Long JA, Descotes JL, Skowron O, Troccaz J, Cinquin P, Boillot B, Terrier N, Rambeaud JJ. [Use of robotics in laparoscopic urological surgery: state of the art]. Prog Urol. 2006 Feb;16(1):3-11. Review. French.

ReferenceCitation: Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy. Surg Endosc. 2002 Sep;16(9):1267-70. Epub 2002 Jun 14.

ReferenceCitation: Jarry J, Moreau Gaudry A, Long JA, Chipon E, Cinquin P, Faucheron JL. Miniaturized robotic laparoscope-holder for rectopexy: first results of a prospective study. J Laparoendosc Adv Surg Tech A. 2013 Apr;23(4):351-5. doi: 10.1089/lap.2012.0233. Epub 2013 Mar 11.

name: Department of Surgery, Desgenettes Hospital, Lyon, France.

family: Jarry

full_name: Julien Jarry

given: Julien

name: Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques, et Applications de Grenoble (TIMC-IMAG) Laboratory, Computer-Aided Medical Interventions (CAMI) Team, Université Joseph Fournier (UJF), Grenoble, France.

family: Moreau Gaudry

full_name: Alexandre Moreau Gaudry

given: Alexandre

name: University Hospital of Grenoble, Grenoble, France.

family: Long

full_name: Jean Alexandre Long

given: Jean Alexandre

name: Clinical Investigation Centre—Innovative Technology, INSERM, Grenoble, France.

family: Chipon

full_name: Emilie Chipon

given: Emilie

family: Cinquin

full_name: Philippe Cinquin

given: Philippe

family: Faucheron

full_name: Jean Luc Faucheron

given: Jean Luc

journal_name: Journal of Laparoendoscopic & Advanced Surgical Techniques

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Miniaturized Robotic Laparoscope-Holder for Rectopexy: First Results of a Prospective Study

location_facility:
University Hospital, Saint-Etienne
University Hospital, Grenoble


title: Urinary Ratio of the Coproporphyrins Isomers I and III and Its Relationships With Methotrexate Elimination in Patients With a Lymphoid Malignancy

acronym: COMETH

summary: High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known but some patients still experience toxicity despite adequate measures being taken. Our hypothesis is that renal tubular secretion may be impaired in these patients. This study aims at evaluating the performance of the UCP ratio (urinary ratio of coproporphyrins), a putative biomarker of tubular secretion, in predicting delayed MTX elimination.

ReferenceCitation: Benz-de Bretagne I, Zahr N, Le Gouge A, Hulot JS, Houillier C, Hoang-Xuan K, Gyan E, Lissandre S, Choquet S, Le Guellec C. Urinary coproporphyrin I/(I + III) ratio as a surrogate for MRP2 or other transporter activities involved in methotrexate clearance. Br J Clin Pharmacol. 2014 Aug;78(2):329-42. doi: 10.1111/bcp.12326.

name: Laboratoire de Biochimie et Biologie Moléculaire; CHRU de Tours; Tours France

name: Université François Rabelais de Tours; PRES Centre Val de Loire Université; EA4245 Tours France

family: Benz-de Bretagne

full_name: Isabelle Benz-de Bretagne

given: Isabelle

name: Service de Pharmacologie; CHU Pitié-Salpêtrière; AP-HP Paris France

family: Zahr

full_name: Noël Zahr

given: Noël

name: CHRU de Tours; Centre d'investigation clinique; Tours France

name: Université François Rabelais de Tours; PRES Centre Val de Loire Université; Inserm 202 Tours France

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

name: UPMC Université Paris 06; UMR_S 956 Paris France

family: Hulot

full_name: Jean-Sébastien Hulot

given: Jean-Sébastien

name: Service de Neurologie; CHU Pitié-Salpêtrière; Centre expert national LOC; AP-HP Paris France

family: Houillier

full_name: Caroline Houillier

given: Caroline

family: Hoang-Xuan

full_name: Khe Hoang-Xuan

given: Khe

name: Service d'Hématologie et Thérapie Cellulaire; CHRU de Tours; Tours France

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

family: Lissandre

full_name: Séverine Lissandre

given: Séverine

name: Service d'Hématologie; CHU Pitié-Salpêtrière; AP-HP Paris France

family: Choquet

full_name: Sylvain Choquet

family: Le Guellec

full_name: Chantal Le Guellec

given: Chantal

journal_name: British Journal of Clinical Pharmacology

oa_colors: green hybrid

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility:
University Hospital Centre of Tours
Pitié-Salpêtrière Hospital


title: Comparison of Externally Versus Internally Cooled Tip Catheter in Achieving Long-term Electrical Isolation of Pulmonary Veins in Paroxysmal Atrial Fibrillation

acronym: CATAFABL

summary:
There is no study comparing safety/efficacy of externally vs internally cooled tip catheters in patients undergoing ablation for paroxysmal atrial fibrillation (pAF).

The primary objective is to compare safety and efficacy of externally irrigated-tip catheter versus internally irrigated-tip catheter in achieving long term electrical isolation (EI) of pulmonary veins (PV) in paroxysmalatrial fibrillation (pAF).

location_facility:
University Hospital
Clinique Pasteur


title: Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers

summary: To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.

lead_sponsor: UCB Pharma


title: Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant

summary: Impact of fermented milk in prevention of cow's milk allergy in new born and infants

lead_sponsor: Bledina

location_facility:
Hôpital Saint Vincent de Paul
Hôpital central


title: A Multicentre Phase II Trial to Determine the Efficacy of the Anti-Tyrosine Kinase Sunitinib (Sutent®) as Second Line Therapy in Patients With Transitional Cell Carcinoma (TCC) of the Urothelium Which Failed or Progressed After First Line Chemotherapy for Advanced or Metastatic Disease

summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line therapy in treating patients with locally advanced or metastatic transitional cell cancer.

lead_sponsor: Institut Curie

location_facility:
Centre Rene Huguenin
Hopital Foch


title: Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients

summary: Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).

ReferenceCitation: Demoule A, Molinari N, Jung B, Prodanovic H, Chanques G, Matecki S, Mayaux J, Similowski T, Jaber S. Patterns of diaphragm function in critically ill patients receiving prolonged mechanical ventilation: a prospective longitudinal study. Ann Intensive Care. 2016 Dec;6(1):75. doi: 10.1186/s13613-016-0179-8. Epub 2016 Aug 5.

family: Demoule

full_name: Alexandre Demoule

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Jung

full_name: Boris Jung

given: Boris

family: Prodanovic

full_name: Hélène Prodanovic

given: Hélène

family: Chanques

full_name: Gerald Chanques

given: Gerald

family: Matecki

full_name: Stefan Matecki

given: Stefan

family: Mayaux

full_name: Julien Mayaux

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Jaber

full_name: Samir Jaber

given: Samir

journal_name: Annals of Intensive Care

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - @rchiveSIC

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

ReferenceCitation: Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Diaphragm Dysfunction on Admission to the Intensive Care Unit. Prevalence, Risk Factors, and Prognostic Impact—A Prospective Study

location_facility: Department of Anesthesia and Critical Care (DAR B)


title: Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology

summary:
We have developed a positioning cushion for LP which allows the child to be relaxed in an adequate position, and to maintain this position throughout LP. This study was aimed at evaluating the benefit of the device on the technical quality of LPs, on pain, anxiety, post LP syndrome, and on the satisfaction of children, their parents and caregivers.

The study was a two-centre, open, randomized trial, with two parallel groups. Children aged 2 to 18 years undergoing a LP were eligible, if not included in the study before. Those who had used the cushion before, with a medical reason preventing the use of the cushion, those refusing or whose parents refused could not be included. Randomization was stratified by centre.

Four cushion sizes were available for the age ranges: 2-6 years, 6-10 years, 10-15 and 15-18 years. The primary outcome was the rate of success, defined as a LP reaching its objective at the first attempt, without hemorrhage (visible hemorrhage or RBC > 50/mm3 in the CSF sample). Secondary outcomes included: the child's pain using a visual analogic scale (VAS), parents and caregiver perception of the child's pain (VAS); the children, parents, caregiver and physician performing the LP satisfaction; children cooperation using the "Le Baron Scale", and the occurrence of a post LP syndrome.

ReferenceCitation: Marec-Bérard P, Bissery A, Kebaïli K, Schell M, Aubert F, Gaillard S, Rabilloud M, Kassaï B, Cornu C. A positioning pillow to improve lumbar puncture success rate in paediatric haematology-oncology patients: a randomized controlled trial. BMC Cancer. 2009 Jan 15;9:21. doi: 10.1186/1471-2407-9-21.

family: Marec-Bérard

full_name: Perrine Marec-Bérard

given: Perrine

family: Bissery

full_name: Alvine Bissery

given: Alvine

family: Kebaïli

full_name: Kamila Kebaïli

given: Kamila

family: Schell

full_name: Matthias Schell

given: Matthias

family: Aubert

full_name: Françoise Aubert

given: Françoise

family: Gaillard

full_name: Ségolène Gaillard

given: Ségolène

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Kassaï

full_name: Behrouz Kassaï

given: Behrouz

family: Cornu

full_name: Catherine Cornu

given: Catherine

journal_name: BMC Cancer

lead_sponsor: Centre Leon Berard

location_facility:
Hopital Debrousse
centre Leon Berard


title: A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

summary:
Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.

The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.

lead_sponsor: Laboratoires URGO

location_facility:
Clinical Investigation Center
Hopital Cardiovasculaire Louis Pradel


title: Influence of Different Exercise Training Programs in Patients With Coronary Artery Disease on Cardiac and Respiratory Parameters

acronym: FRAXIO

summary: The benefits of cardiac rehabilitation have been clearly demonstrated. In particular exercise training is recognized to be part of modern management after coronary artery disease. However methods of prescribing exercise-training programs and the exercise intensity are difficult to determine. The objective of this randomised clinical trial is to determine whether appropriate endurance exercise training improves the ventilatory threshold, the exercise tolerance and the quality of life in patients with coronary artery disease. Patients are randomized to continuous training or aerobic interval training respectively: 80%-versus maximal-workload at the ventilatory threshold. For each patient, the intensity of exercise training is determined by a first exercise test with gas analysis using parameters of sub maximal exercise capacity such as ventilatory threshold. Others parameters of functional capacity are also considered. Duration of the rehabilitation stage is between 7 to 10 weeks. Dyspnoea assessment at maximal intensity, quality of life measurement by SF36, drugs and events are reported. Maximal exercise tests with gas exchange measurements are performed after training program and at 6 months follow-up to compare the different cardio respiratory parameters in the two groups before and after exercise training and to evaluate the more effective endurance training program.

lead_sponsor: University Hospital, Limoges


title: Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.

summary: The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Clermont-Ferrand
CPC-CIC


title: Evaluation of the Interaction of Rimonabant (Antagonist of CB1 Receptor) on the Analgesic Effect of Paracetamol in Intravenous Administration

summary: Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of Paracetamol in healthy volunteers

location_facility:
CIC-CPC
CHU Clermont-Ferrand


title: Fiberoptic Bronchoscopy With Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol Target Controled Infusion in Patient With Acute Hypoxemic Respiratory Failure. A Randomized Controlled Study : SEDA-FIBRO.

acronym: SEDA-FIBRO

summary:
Fiberoptic bronchoscopy (FOB) is an important tool for the diagnosis of pulmonary diseases, more particularly in infectious pneumonia. In patients with severe acute hypoxemic respiratory failure, FOB may be contra-indicated until the patient is intubated and control of its oxygenation obtained. In the literature several authors showed that performing FOB under non invasive ventilation (NIV) preserved oxygenation of the patient; and the recent French Consensus on NIV recommends performing FOB under NIV in patients with acute hypoxemic respiratory failure.

Nevertheless this procedure remains uncomfortable in most patients with respiratory failure. In addition, patient's agitation may lead to desaturation, and compromise the realization of FOB.

ReferenceCitation: Constantin JM, Schneider E, Cayot-Constantin S, Guerin R, Bannier F, Futier E, Bazin JE. Remifentanil-based sedation to treat noninvasive ventilation failure: a preliminary study. Intensive Care Med. 2007 Jan;33(1):82-7. Epub 2006 Nov 14.

ReferenceCitation: Nieuwenhuijs D, Sarton E, Teppema LJ, Kruyt E, Olievier I, van Kleef J, Dahan A. Respiratory sites of action of propofol: absence of depression of peripheral chemoreflex loop by low-dose propofol. Anesthesiology. 2001 Oct;95(4):889-95.

location_facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin


title: Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study

acronym: CAIMAN

summary:
-Context: Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.

Primary Hypothesis:

More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during cocaine detoxification.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse

location_facility: Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot


title: Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis

acronym: AMBIDEX

summary:
To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.

Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.

The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed

ReferenceCitation: Azoulay E, Timsit JF, Lautrette A, Legriel S, Max A, Ruckly S, Misset B, Cohen Y, Wolff M. Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study. PLoS One. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093. eCollection 2017.

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Lautrette

full_name: Alexandre Lautrette

given: Alexandre

family: Legriel

full_name: Stephane Legriel

given: Stephane

family: Max

full_name: Adeline Max

given: Adeline

family: Ruckly

full_name: Stephane Ruckly

family: Misset

full_name: Benoit Misset

given: Benoit

family: Cohen

full_name: Yves Cohen

given: Yves

family: Wolff

full_name: Michel Wolff

given: Michel

journal_name: PLOS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

lead_sponsor: Fovea

location_facility:
Chu Michallon
Hopital Saint Louis


title: Randomized Phase III Study Comparison Between Conventional Chemotherapy and High-Dose Therapy Followed by Autologous Purged Stem-Cell Transplantation in Patients With Follicular Lymphoma Stage III,IV First-Line Treatment for Patients Younger Than 60 Years Old With a High Tumor Burden

summary: Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to 30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the treatment, no plateau appears on survival curves, and virtually all patients relapse; follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line treatment is clearly defined. One of the most active therapies is still doxorubicin-based chemotherapy with or without interferon.7-9 New therapeutic approaches including purine analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage treatment for patients with relapsing follicular lymphoma is demonstrated by some authors; several reports have shown the superiority of HDT followed by autologous stem-cell transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no relapse and overall survival.14-18 Only a few reports have been published showing HDT results as a first-line treatment for poor-risk patients with follicular lymphoma, and the results remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients with newly diagnosed follicular lymphoma with a high tumor burden. A combined doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT followed by purged autologous stem-cell transplantation.

ReferenceCitation: Gyan E, Foussard C, Bertrand P, Michenet P, Le Gouill S, Berthou C, Maisonneuve H, Delwail V, Gressin R, Quittet P, Vilque JP, Desablens B, Jaubert J, Ramée JF, Arakelyan N, Thyss A, Moluçon-Chabrot C, Delépine R, Milpied N, Colombat P, Deconinck E; Groupe Ouest-Est des Leucémies et des Autres Maladies du Sang (GOELAMS). High-dose therapy followed by autologous purged stem cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by the GOELAMS with final results after a median follow-up of 9 years. Blood. 2009 Jan 29;113(5):995-1001. doi: 10.1182/blood-2008-05-160200. Epub 2008 Oct 27.

name: Department of Hematology, Bretonneau University Hospital, Tours;

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

name: Department of Hematology, University Hospital, Angers;

family: Foussard

full_name: Charles Foussard

given: Charles

name: Department of Biostatistics, Faculty of Medicine, Tours;

family: Bertrand

full_name: Philippe Bertrand

given: Philippe

name: Department of Pathology, Centre Hospitalier, Orléans;

family: Michenet

full_name: Patrick Michenet

given: Patrick

name: Department of Hematology, University Hospital of Nantes, Nantes;

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

name: Department of Hematology, University Hospital, Brest;

family: Berthou

full_name: Christian Berthou

given: Christian

name: Department of Hematology, Centre Hospitalier, La Roche-sur-Yon;

family: Maisonneuve

full_name: Hervé Maisonneuve

given: Hervé

name: Department of Hematology, University Hospital of Poitiers, Jean Bernard Hospital, Poitiers;

family: Delwail

full_name: Vincent Delwail

given: Vincent

name: Department of Hematology, University Hospital, Grenoble;

family: Gressin

full_name: Rémi Gressin

given: Rémi

name: Department of Hematology, University Hospital of Montpellier, Montpellier;

family: Quittet

full_name: Philippe Quittet

name: François Baclesse Anticancer Center, Caen;

family: Vilque

full_name: Jean-Pierre Vilque

given: Jean-Pierre

name: Department of Hematology, University Hospital, Amiens;

family: Desablens

full_name: Bernard Desablens

given: Bernard

name: Department of Hematology, University Hospital, Saint-Etienne;

family: Jaubert

full_name: Jérôme Jaubert

given: Jérôme

name: Department of Hematology, Catherine de Sienne Clinic, Nantes;

family: Ramée

full_name: Jean-François Ramée

name: Department of Hematology, Georges Pompidou European Hospital, Paris;

family: Arakelyan

full_name: Nina Arakelyan

given: Nina

name: Antoine Lacassagne Anticancer Center, Nice;

family: Thyss

full_name: Antoine Thyss

given: Antoine

name: Department of Hematology, University Hospital, Clermont-Ferrand;

family: Moluçon-Chabrot

full_name: Cécile Moluçon-Chabrot

given: Cécile

family: Delépine

full_name: Roselyne Delépine

given: Roselyne

name: Department of Hematology, University Hospital of Bordeaux, Bordeaux; and

family: Milpied

full_name: Noël Milpied

given: Noël

family: Colombat

full_name: Philippe Colombat

name: Inserm, U645, Franche-Comté University and Department of Hematology, Jean Minjoz Hospital, Besançon, France

family: Deconinck

full_name: Eric Deconinck

given: Eric

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology


title: Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI)

acronym: TDA/H

summary: The aim of this study is to investigate the integrity of connectivity between the neocortex and the cerebellum in the Attention Deficit Hyperactivity Disorder (ADHD). Fibers integrity will be measured using magnetic Resonance Imaging Techniques.

location_facility:
University Hospital Bordeaux
Charles Perrens Hospital


title: Double-Blind vs Placebo, Randomized, Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 500 mg QD for One Month in Patients With Non-Alcoholic Steatohepatitis (NASH)

summary: The purpose of this study is to assess the safety, the tolerability and the short term effect on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic Steatohepatitis (NASH).

lead_sponsor: Hoffmann-La Roche

location_facility: Groupe Hospitalier Pitié-Salpétrière - Sce Hépato-Gastroentérologie - 47-83 Bd de l'Hôpital

location_facility: Hôpital Archet 2 - Pôle de Référence Hépatite C (Niveau -2) - 151, route Saint Antoine de Ginestière


title: Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension

acronym: ETHAPE

summary: In order to improve effectiveness of the surgical operation thanks to a reduction in the rate of failure, this study will allow us to identify predictive angiographic and CT finding of surgical failure, starting from standardized reading grids, in order to have a better selection of the operable patients.

location_facility:
Hospital Marie Lannelongue
Hôpital Antoine Beclere


title: Can Ultrasound Predict Success of Median Nerve Block? Relationship Between Diffusion of Local Anesthetic and Effectiveness of a Nerve Block

acronym: Echoalr

summary: Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in orthopedic surgery. Even realised by experienced anaesthetists,a failure rate of 5-15% is noticed. The principal aim of the study is to observe the local anesthetic solution diffusion after a conventional median nerve block technique using neurostimulation. The secondary objective is to compare diffusion and of block efficacy..

location_facility:
Hôpital Foch
Hôpital privé de l'Ouest Parisien


title: ErythroPOietin in Myocardial Infarction

acronym: EPOMI

summary: EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.

ReferenceCitation: Prunier F, Bière L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genée O, Guérin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delépine S, Benard T, Furber A. Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial. Am Heart J. 2012 Feb;163(2):200-7.e1. doi: 10.1016/j.ahj.2011.11.005.

family: Prunier

full_name: Fabrice Prunier

given: Fabrice

family: Bière

full_name: Loïc Bière

given: Loïc

family: Gilard

full_name: Martine Gilard

given: Martine

family: Boschat

full_name: Jacques Boschat

given: Jacques

family: Mouquet

full_name: Frédéric Mouquet

given: Frédéric

family: Bauchart

full_name: Jean-Jacques Bauchart

given: Jean-Jacques

family: Charbonnier

full_name: Bernard Charbonnier

family: Genée

full_name: Olivier Genée

given: Olivier

family: Guérin

full_name: Patrice Guérin

given: Patrice

family: Warin-Fresse

full_name: Karine Warin-Fresse

given: Karine

family: Durand

full_name: Eric Durand

family: Lafont

full_name: Antoine Lafont

family: Christiaens

full_name: Luc Christiaens

given: Luc

family: Abi-Khalil

full_name: Wissam Abi-Khalil

given: Wissam

full_name: Stéphane Delépine

given: Stéphane

family: Benard

full_name: Thomas Benard

given: Thomas

family: Furber

full_name: Alain Furber

given: Alain

journal_name: American Heart Journal

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the Erythropoietin in Myocardial Infarction Trial

lead_sponsor: University Hospital, Angers

location_facility:
CHU Angers
Fabrice PRUNIER, MD, PhD,


title: Effectiveness of Standard Emergency Department Psychiatric Treatment Compared With Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center.

summary:
Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_normalized: University of Melbourne - Minerva Access

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

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Bristol - Bristol Research

lead_sponsor: University Hospital, Toulouse

location_facility:
Service d'Accueil des Urgences
Laboratoire de Stress Post-Traumatique