title: Assessment of Extravascular Lung Water and Hemodynamics Changes in Patients Treated by High Frequency Oscillation-ventilation for Refractory ARDS

summary: The study is intended to evaluate the hemodynamic and the indexed extrapulmonary lung water (ELWI) changes in patients treated by high frequency oscillation-ventilation (HFO-V) for refractory acute respiratory distress syndrome (ARDS). HFO-V may be used as rescue treatment in refractory ARDS but its hemodynamic impact is discussed. Moreover, as Extra Vascular Lung Water (a transpulmonary thermodilution parameter) was proven to be an independent mortality factor in ICU-patients, the investigators decided to monitor it in all ARDS patients who ended up needing HFO-V, from HFO-V plugging under 72 hours of this type of ventilation. All ARDS patients underwent high Positive End Expiratory Pressure (PEEP) with "protective ventilation" and those who remained below a PaO2/FiO2 ratio of 120 after 24h will be considered as "refractory ARDS patients" and, therefore eligible. They will be monitored by the transpulmonary thermodilution PiCCO technique (Pulsion Medical System. Munich, Germany) and placed under HFO-V. Both transpulmonary thermodilution measurements (ELWI , Cardiac Output, Global End-diastolic Volume) and standard transthoracic echocardiographic measurements (Ejection Fraction, End-diastolic Right and Left Ventricular Area, preload indexes) were be performed from HFO-V plugging to Day 3. The investigators suggest that ELWI will be correlated to HFO-V responsiveness and that cardiac output will not change at the HFO-V plugging, regardless of preload indexes variation. Inclusion will be proceeded over a 2 year period and, according to the population, the investigators expect about 50 eligible patients.

ReferenceCitation: Simma B, Fritz M, Fink C, Hammerer I. Conventional ventilation versus high-frequency oscillation: hemodynamic effects in newborn babies. Crit Care Med. 2000 Jan;28(1):227-31.

ReferenceCitation: Traverse JH, Korvenranta H, Adams EM, Goldthwait DA, Carlo WA. Cardiovascular effects of high-frequency oscillatory and jet ventilation. Chest. 1989 Dec;96(6):1400-4.

ReferenceCitation: Arnold JH, Truog RD, Thompson JE, Fackler JC. High-frequency oscillatory ventilation in pediatric respiratory failure. Crit Care Med. 1993 Feb;21(2):272-8.

ReferenceCitation: Zobel G, Dacar D, Rödl S. Hemodynamic effects of different modes of mechanical ventilation in acute cardiac and pulmonary failure: an experimental study. Crit Care Med. 1994 Oct;22(10):1624-30.

ReferenceCitation: Jabot J, Teboul JL, Richard C, Monnet X. Passive leg raising for predicting fluid responsiveness: importance of the postural change. Intensive Care Med. 2009 Jan;35(1):85-90. doi: 10.1007/s00134-008-1293-3. Epub 2008 Sep 16.

ReferenceCitation: Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.

ReferenceCitation: Sakka SG, Klein M, Reinhart K, Meier-Hellmann A. Prognostic value of extravascular lung water in critically ill patients. Chest. 2002 Dec;122(6):2080-6.

ReferenceCitation: Craig TR, Duffy MJ, Shyamsundar M, McDowell C, McLaughlin B, Elborn JS, McAuley DF. Extravascular lung water indexed to predicted body weight is a novel predictor of intensive care unit mortality in patients with acute lung injury. Crit Care Med. 2010 Jan;38(1):114-20. doi: 10.1097/CCM.0b013e3181b43050.

ReferenceCitation: Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.

ReferenceCitation: Ursulet L, Roussiaux A, Belcour D, Ferdynus C, Gauzere BA, Vandroux D, Jabot J. Right over left ventricular end-diastolic area relevance to predict hemodynamic intolerance of high-frequency oscillatory ventilation in patients with severe ARDS. Ann Intensive Care. 2015 Dec;5(1):25. doi: 10.1186/s13613-015-0068-6. Epub 2015 Sep 17.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Réanimation polyvalente, University Hospital Reunion Island - Felix Guyon Site


summary:
The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung cancer.

First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of the study:RAD001 (everolimus) will be administered per os every day one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1, D8, every 21 days.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Activating Receptors and DAP12 Protein in Wegener's Granulomatosis

summary: The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an assortment of activating NK cell receptors and their signaling partners, in particular DAP12. The investigators hypothesize that DAP12, or a downstream signaling target of DAP12, is the missing link between the different cell components involved in WG (neutrophils, macrophages, CD4 T cells).

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological

status_simplified: Completed


title: The Main Objective of This Study is to Evaluate the Virologic Effectiveness at M6 of Regimen Containing Raltegravir in Treatment Naive HIV Subtype Non B or B Infected Subjects

acronym: Ral'inNONB

summary: Pilot open label multicentric study

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Intercommunal Robert Ballanger


title: Uveitis: Medico-economical and Clinical Evaluation of a Standardized Strategy for an Etiological Diagnosis

acronym: ULISSE

summary:
The Uveitis, the inflammation of the uvea, is a rare disease with an incidence of 52/100,000 inhabitants per year and a prevalence of 115 / 100,000 inhabitants per year.

The causes of uveitis are numerous and include infectious diseases, systemic and neurological diseases, ophthalmic entities, neoplasia, and drug-related reactions. The etiological diagnosis is important both for prognosis and therapeutics.

However, clinical evaluations to establish etiological diagnosis are not standardized. Some authors suggest a minimalist examination, common to all kinds of uveitis. On the other hand, others propose an evaluation guided by the anatomo-clinical type of uveitis.

We conducted a retrospective study to assess the contribution of complementary examinations to etiological determination. In this study, we found that most patients benefited from a wide paraclinical evaluation compared to what is usually described in the literature. Complementary examinations were mostly systematic, without any clinical or ophthalmological elements of orientation. This study highlighted the lack of contribution of some examinations.

Using these results, and the literature analysis, we designed a diagnostic algorithm adapted to the anatomo-clinical type of uveitis.

Moreover, we found that the average cost per patient was estimated at €290.51 with the algorithm compared to €560.83 without it.

We would like to carry out a new study to estimate the efficiency as well as the medico-economic impact of the use of a standardized strategy for the etiological diagnosis of uveitis, compared with a free strategy.

Hypothesis:

The standardized strategy for the diagnostic of uveitis is at least as efficient as the free one, and costs half as much.
The examinations prescribed, except for those from the standardized strategy, do not contribute to etiological determination.

design_allocation: Randomized

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: de Parisot A, Kodjikian L, Errera MH, Sedira N, Heron E, Pérard L, Cornut PL, Schneider C, Rivière S, Ollé P, Pugnet G, Cathébras P, Manoli P, Bodaghi B, Saadoun D, Baillif S, Tieulie N, Andre M, Chiambaretta F, Bonin N, Bielefeld P, Bron A, Mouriaux F, Bienvenu B, Vicente S, Bin S, Broussolle C, Decullier E, Sève P; ULISSE group. Randomized Controlled Trial Evaluating a Standardized Strategy for Uveitis Etiologic Diagnosis (ULISSE). Am J Ophthalmol. 2017 Jun;178:176-185. doi: 10.1016/j.ajo.2017.03.029. Epub 2017 Mar 31.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Médecine Interne, Hospices Civils de Lyon (HCL)-Hôpital de la Croix Rousse

intervention_type: Other


title: Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome Definition in Intensive Care Unit

summary:
The ARDS has a clinical definition with criteria of the American-European Consensus Conference (1994). This definition inconveniently applies to a lot of patients with acute respiratory failure.

We know that there are 2 forms of ARDS morphology on CT scan : "lobar attenuation" (loss of aeration with no concomitant excess in lung tissue) predominating in the lower lobes and "non lobar attenuation" with diffuse and massive loss of aeration with excess lung tissue in all the pulmonary parenchyma.

Today, plasmatic biomarkers are used as prognostic and diagnostic markers of ARDS. Some of them are characteristics of the different damages in the ARDS (alveolar epithelium and vascular endothelium lesions) : sRAGE, SP-D, PAI 1 and sICAM 1.

This study's hypothesis is that patients with ARDS criteria and lobar morphology on CT scan present loss of aeration but no inflammatory pulmonary oedema, whereas patients with non lobar morphology on CT scan present both characteristics.

The primary purpose of our protocol is to show that the patients who respond to ARDS criteria and have a lobar morphology on CT scan do not have an elevation of the biomarkers specific to the pulmonary aggression of ARDS.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Procedure


title: Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet

acronym: NAVAHELMET

summary: Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. The use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. However, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.

lead_sponsor: Pierre and Marie Curie University

location_facility: Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care

intervention_type: Device


type: Other Identifier

title: Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren

acronym: REGUL'APS

summary:
In French primary schools, children participate in 3 compulsory hours of physical education (PE) each week unless they have a medical contra-indication. But, there is no scientific evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of PE brings or not the same effects, particularly to prevent overweight or obesity.

Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed of a BMI increase and on health-related quality of life (HRQoL) over the school year.

Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL

primary_purpose: Prevention

lead_sponsor: University of Nancy

location_facility: Public health School, Laboratory EA4360 Apemac


title: Pilot Study of EEG Signs of Awakening Secondary to Injection of Sugammadex: Evaluation by Recording Bispectral Index and NeuroSENSE (Prospective, Double-blind Study)

acronym: Sugarecovery

summary:
It has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1) affects depth of anaesthesia with an increase in bispectral index (mean maximal change of 7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7).

Sugammadex has a quicker and more complete effect than neostigmine. This study aims to demonstrate if sugammadex administration increases bispectral and neurosense indices of the depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.

ReferenceType: background

ReferenceCitation: Vasella FC, Frascarolo P, Spahn DR, Magnusson L. Antagonism of neuromuscular blockade but not muscle relaxation affects depth of anaesthesia. Br J Anaesth. 2005 Jun;94(6):742-7. Epub 2005 Mar 18.

ReferenceType: derived

ReferenceCitation: Le Guen M, Roussel C, Chazot T, Dumont GA, Liu N, Fischler M. Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index. Anaesthesia. 2020 May;75(5):583-590. doi: 10.1111/anae.14897. Epub 2019 Dec 5.

lead_sponsor: Hopital Foch


title: Evaluation of Optimal Anatomical Layer for Continuous Wound Infusion of Local Anesthetics Combined With NSAIDs Through a Multiorifice Catheter for Postoperative Pain Intensity After Elective Cesarean Delivery

summary: The purpose of this randomized double-blind study is to evaluate in which anatomical layer (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery.

ReferenceCitation: Rackelboom T, Strat SL, Silvera S, Schmitz T, Bassot A, Goffinet F, Ozier Y, Beaussier M, Mignon A. Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):893-900. doi: 10.1097/AOG.0b013e3181f38ac6.

lead_sponsor: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

lead_sponsor_type: industriel


title: Study of the Efficacy and Safety of Treatment With Total Freeze-dried Culture of Lactobacillus Casei Var. Rhamnosus (Lcr35®) Administered Intravaginally in the Prevention of Bacterial Vaginosis. Randomized, Phase III, Multi-centre, Double-blind, Placebo-controlled Superiority Trial

summary:
This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III superiority trial.

The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean time before the onset of the first clinical recurrence confirmed by laboratory tests in patients with bacterial vaginosis treated with Lcr35® versus placebo.

Patients with bacterial vaginosis will be enroll by private gynecologists. Each patient will receive a treatment for the initial episode(Metronidazole)and a treatment to prevent the recurrence of bacterial vaginosis (Lcr35®).

lead_sponsor: Laboratoires Lyocentre


title: A Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS (BAFF) Antibody, in Subjects With Primary Sjögren's Syndrome

acronym: BELISS

summary: Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.

ReferenceCitation: Bowman SJ, Fisher BA. Stratifying primary Sjögren's syndrome: killers in the balance? Arthritis Res Ther. 2015 Dec 7;17:351. doi: 10.1186/s13075-015-0878-9.

ReferenceCitation: Seror R, Nocturne G, Lazure T, Hendel-Chavez H, Desmoulins F, Belkhir R, Ravaud P, Benbijja M, Poirier-Colame V, Taoufik Y, Mariette X. Low numbers of blood and salivary natural killer cells are associated with a better response to belimumab in primary Sjögren's syndrome: results of the BELISS study. Arthritis Res Ther. 2015 Sep 4;17:241. doi: 10.1186/s13075-015-0750-y.

location_facility: Assistance Publique - Hôpitaux de Paris : BICETRE Hospital


title: Arterial Microcirculation, Macrocirculation and Thrombophilias

acronym: MICMAC

summary:
Rationale: To analyse the arterial state of women with thrombophilia by techniques studying micro and arterial macrocirculation because of a reported and still discussed increase risk in cardio-vascular events in these women.

Primary objective: To measure endothelium dependent vasodilatation (VDE) in controls and in women with thrombophilia.

location_facility: Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase


title: A Randomized Investigator And Subject-Blind, Sponsor Open, Placebo Controlled Phase 1 Study To Characterize The Safety, Tolerability, And Pharmacokinetics Of Ascending Multiple Doses Of PF-05212377 (SAM-760) Administered Orally To Healthy Young And Elderly Subjects

acronym: MAD

summary: This is a multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to healthy young adults and healthy elderly subjects. The study will be conducted under double-blind conditions (neither the investigator nor the subject will know if he/she has received PF-05212377 or a placebo). The Sponsor will know if the subject has received active treatment or a placebo.

lead_sponsor: Pfizer


type: EudraCT Number

title: A Randomized, Double Blind Study to Assess the Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart

summary:
Primary Objective:

To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes.

Secondary Objectives:

Pharmacodynamic objectives:

To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart.

Pharmacokinetic objective:

To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups

Safety objective:

To assess the safety of insulin glulisine in comparison to insulin aspart

lead_sponsor: Sanofi


title: Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study

summary: A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.

lead_sponsor: Ekkyo


title: Early Cognitive Impairment in Multiple Sclerosis: a Multimodal MRI Study Evaluating the Relative Contribution of Cortical and White Matter Tract Injury

acronym: CogniSEP

summary:
Cognitive impairment is one of the symptoms of Multiple Sclerosis (MS), and it may occur during the first years of the disease. It usually affects attention, information processing speed and short term memory. To date, the mechanisms of this specific symptom remain unclear (local or global inflammation, neurodegenerative processes).

Magnetic Resonance Imaging (MRI) can be useful to understand the pathophysiology of cognitive impairment in MS. The investigators will combine conventional and non conventional MRI sequences to determine the respective role of white matter and grey matter injury and the cortical reorganization of neuronal networks.


title: Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

summary:
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.

The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.


title: Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours

acronym: ACIC

summary: The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects

status: Terminated

lead_sponsor: Nantes University Hospital


title: Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma

acronym: Rice NK

summary:
To date, no curative option exists for patients with relapsed or refractory stage IV neuroblastoma after previous autologous stem cell transplantation. Our preliminary results of RIC allo-HSCT (protocol RICE) indicate the feasability and low toxicity of allograft in heavily pre-treated children. Furthermore RIC SCT and immunomagnetic CD3/CD19 graft depletion may allow HHCT with lower toxicity and faster engraftment. CD3/CD19 depleted grafts not only contain CD34+ stem cells but also graft-facilitating cells, CD34- progenitors, dendritic and natural killer cells which may allow stable engraftment and participate to GvT effect.

After haploidentical stem cell transplantation anti tumour activity exerted by donor derived NK cells could be stimulated by NK cells injections. Those effects may help to reduce the relapse rate and to impove the outcome of those patients. The investigators prospectively evaluated engraftment and immune reconstitution.


title: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)

summary: The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.

lead_sponsor: Laboratoires Thea


title: Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan® in ocular hypertensive or glaucomatous patients. Phase III study, multicentre, international, randomised, investigator-masked, 2 parallel groups, versus Reference product, in 400 evaluable patients treated during 3 months.

source: euctr

summary: The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.


title: clinical efficacy and safety of azyter (azythromycin 1,5%) versus tobramycin 0,3% eye drops in the treatment of purulent bacterial conjonctivitis of children. multicenter, international, investigator-masked, randomised, phase IIIB study, parallel comparaison versus reference product, 2 X 111 evaluable patients.

summary: Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.


title: Safety and Efficacy Assessment of Geltim LP® 1 mg/g (Unpreserved Timolol Gel - TG1030) in Ocular Hypertensive or Glaucomatous Patients Stabilized by Xalatan® With Ocular Intolerance Signs.

summary: This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.


title: Influence of Lidocaine on a Closed-Loop Anesthesia System

acronym: LoopLido

summary: The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.


title: Impact of Ultrasound Guided Central Venous Catheterization on Complications in Obese Patients in Intensive Care Unit

acronym: CATHETER

summary:
Central venous catheterization (CVC) in ICU is very common. It is associated with many complications. These complications are now well identified in the literature. They are primarily mechanical, infectious and thrombotic events. Many measures are taken to reduce them as the choice of insertion site, strict aseptic technique during insertion and type of catheter used. However, despite these measures, it appears that the incidence of these complications is still high. The technique of ultra-sound guided (USG) catheter insertion has shown its effectiveness in reducing complications in the general ICU population. The increase in obesity in the general population is accompanied by an increase in the obese population in the ICU (BMI > 30 kg.m-2). Many studies have investigated the effect of obesity on morbidity and mortality in ICU. Some studies found a higher rate of catheter infections in obese patient. Moreover, insertion of central venous catheter is technically more difficult in obese patients.

To the investigators knowledge there are no studies on the impact of USG central venous catheterization in obese patients in ICU.

The objective of this prospective randomized controlled study is to demonstrate the superiority of USG central venous catheterization (jugular or femoral) on complications in a population of obese patients. 450 patients will be included and dispatched in two groups (jugular or femoral) according to the chosen site of catheter insertion. In both groups, patients will be randomized in the USG technique or the usual anatomical technique.

The rate of complications (mechanical, thrombotic or infectious) will be the primary endpoint. Secondary endpoints will be the following: rate of catheter colonization, rate of catheter-related bacteremia, rate of failure during insertion, number of punctures, procedure timing and mortality The investigators hope to establish a benefit in the use of USG central venous catheterization in obese ICU patients and thus contribute to improve the quality of care.

study_start_date_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Universitaire d'Amiens


type: Registry Identifier

title: CT Coronary Angiography for the Detection of Reimplanted Coronary Lesions in Patients Who Had Undergone Arterial Switch Operation for Transposition of the Great Arteries

acronym: SCANTGV

summary: The purpose of this study is to find a non-invasive alternative (with using ECG gated 64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in patients who had undergone arterial switch operation for transposition of the great arteries


title: Paracetamol Metabolism in Post Operative Conditions

summary: Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)


title: Evaluation Chez Des Sujets Sains d'Une Nouvelle Technique d'étude de la Microcirculation cutanée

acronym: Speckle-move

summary: We aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow during exercise.

ReferenceCitation: Mahé G, Haj-Yassin F, Rousseau P, Humeau A, Durand S, Leftheriotis G, Abraham P. Distance between laser head and skin does not influence skin blood flow values recorded by laser speckle imaging. Microvasc Res. 2011 Nov;82(3):439-42. doi: 10.1016/j.mvr.2011.06.014. Epub 2011 Jul 14.

lead_sponsor: University Hospital, Angers


title: Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic

acronym: Cesar-Dol

summary: Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.

ReferenceCitation: Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloë PA, Fischler M, Le Guen M. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014 Aug 5;9(8):e103971. doi: 10.1371/journal.pone.0103971. eCollection 2014.


title: Prise en Charge Pharmacologique de l'anxiété et de la Douleur Chez Les Patients Qui Souffrent en Situation d'Urgence Traumatique pré-hospitalière : étude randomisée contrôlée en Double Aveugle

lead_sponsor: University Hospital, Toulouse

summary: Unexpected acute pain in an emergency setting causes anxiety, insecurity, and stress that can diminish perceptions of control over pain and diminish ability to decrease pain. This may interfere with the opioid treatment and poses the question of whether an anxiolytic drug added to the morphine titration could relief pain and/or anxiety. This randomized double-blind group clinical trial is designed to determine the efficacy and safety of hydroxyzine in addition to a conventional intravenous morphine titration protocol.


title: Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus

acronym: SAMU-KEPPRA

summary: Compare the efficiency of the association, first line, the intravenous levetiracetam and the intravenous clonazepam, in that of a monotherapy of clonazepam intravenous in the pre-hospital treatment of tonicoclonic generalised status epilepticus.

ReferenceCitation: Navarro V, Dagron C, Demeret S, An K, Lamhaut L, Bolgert F, Baulac M, Carli P. A prehospital randomized trial in convulsive status epilepticus. Epilepsia. 2011 Oct;52 Suppl 8:48-9. doi: 10.1111/j.1528-1167.2011.03236.x.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of the Testicular Function After Iodine 131 Therapy in Patients With Papillary Carcinoma

acronym: SAPIRA

summary: Papillary cancer may affect patients of any age,with a good prognosis. Most of young patients may hence procreate as often as the general population.131iodine is an essential tool during treatment of thyroid cancer. According literature data, 131iodine given patients may experience exocrine testicular dysfunction with transient azoospermia, as a significant growing number of Desoxyribonucleic acid (DNA) damage may concern the patient or his offspring. The primary purpose will be to study a genomic instability within the germinal line, based on a significant mutation rate analysis in their minisatellites regions after 100 mCi 131 iodine irradiation compared to the baseline spermogram of each patient, thus being his own control case in a cross-over study.The inclusion of 50 patients treated by surgery prior to131iodine would result in statistically significant results.This multicentric cross-over study with a multidisciplinary approach will act for a direct benefit on testis function in patients aged 18-45 treated by 131iodine for thyroid cancer. Samples measurements timing will be: after surgery, 2 and 12 months after 131iodine administration.

ReferenceCitation: Bourcigaux N, Rubino C, Berthaud I, Toubert ME, Donadille B, Leenhardt L, Petrot-Keller I, Brailly-Tabard S, Fromigué J, de Vathaire F, Simon T, Siffroi JP, Schlumberger M, Bouchard P, Christin-Maitre S. Impact on testicular function of a single ablative activity of 3.7 GBq radioactive iodine for differentiated thyroid carcinoma. Hum Reprod. 2018 Aug 1;33(8):1408-1416. doi: 10.1093/humrep/dey222.

location_facility: Saint Antoine Hospital, Endocrinology Unit


title: Genetic Epidemiology of Non-syndromic Dominant Deafness

acronym: SURDOM

summary: Hearing impairment is a common disorder that affects at least 7% of individuals in our countries. Even the causes of hearing impairment are numerous, genetic causes represent the main factor of sensorineural deafness. Among hereditary non-syndromic deafness autosomal-dominant inheritance is observed in about 10-20% of the cases. These forms of deafness are usually post-lingual and progressive. To date more than 41 chromosomal localisation and 21 genes associated to non syndromic dominant deafness have been described. It represents an extreme genetic heterogeneity making difficult the studies of these forms of hearing impairment. But, genetic diagnostic testing is crucial in these cases. Indeed, therapeutic research are in the way to prevent the progression of the disorder. The aim of this work is to establish the prevalence of the different genes involved in these forms of deafness.

location_facility: Hôpital Armand-Trousseau, Service d'ORL pédiatrique et de Chirurgie Maxillo Faciale


title: Phase III Multicenter, Randomised and Double-blind Study Comparing an Oral Immunomodulatory Solution Versus a Placebo in Preventing Severe Acute Mucositis in Head and Neck Cancer Patients Treated Surgically and Concomitantly With Radiochemotherapy

acronym: IMPATOX

summary: This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.

ReferenceCitation: Boisselier P, Kaminsky MC, Thézenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.

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

intervention_type: Dietary Supplement


acronym: SEPSISPAM

summary: The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)

ReferenceCitation: Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Hervé F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.


title: Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus

acronym: THROMBI-SCAN

summary: Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation. The primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal acquisition time offering the best diagnostic performance (early, late or both).


title: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR

acronym: CD lam

summary: Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete remission (CR).

ReferenceCitation: Chevallier P, Saiagh S, Dehame V, Guillaume T, Peterlin P, Bercegeay S, Le Bris Y, Bossard C, Gauvrit I, Dreno B, Juge-Morineau N, Béné MC, Gregoire M. A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients. Hum Vaccin Immunother. 2021 Oct 3;17(10):3511-3514. doi: 10.1080/21645515.2021.1943991. Epub 2021 Jun 21.

location_facility: Cellule de Promotion de la recherche clinique


title: Evaluation of the Sensorial Preference for Balance Control

acronym: PREFSENSOR

summary:
Among the components of postural control, sensorial integration is of crucial importance. The most important sensorial inputs for postural maintenance are the vestibular system which provides information regarding accelerations of the head in space (HORAK 1994), the somatosensory system which provides proprioceptive information that are used to determine changes in body position (INGLIS 1994) and the visual system which provides information for self motion in the environment. The receptors and the integration channel of each sensorial system have inner characteristics which lead to different performance of the different input in regards to the task and the environmental context (FITZGERALD 1994). Most of time, sensorial information are congruent but sometimes they are conflicted. This is the case when being in a stationary train, the train beside going on, giving the illusory sensation of movement even if the vestibular system is not activated. A sensory weighting process is then necessary for subjects to control balance. The Central Nervous System (CNS) is thought to adjust the relative contribution of sensory input to control stance depending on environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002, KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide postural stability. Nevertheless the interconnection of the multiple sensorial feedback involved in the postural control is not yet completely understood (CHIARI 2000).

Today, there is no tool available to evaluate the individual use of the sensorial information to postural control. It seems interesting to have such a tool to better understand the sensorial preference of subjects. It would be of particular importance for patients with various pathologies in the aim to design individualized balance rehabilitation programs.

The aim of the study was to test a tool built to evaluate the sensorial preference of subjects by studying their postural reaction related to the 3 main sensorial perturbations. Normal subjects will be first tested to assess the repeatability of the protocol and to collect normal values. Then, patients with post stroke hemiplegia, vestibular disease, neuropathy and fallers will be studied in order to test the feasibility of the protocol and to have preliminary data of sensorial preference among these populations.

location_facility: Service de MPR - Hôpital Lariboisière - Fernand Widal


title: Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome

acronym: GITAB

summary: Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.


title: Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.

acronym: SENTIBRAS

summary: Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.

ReferenceCitation: Nos C, Lesieur B, Clough KB, Lecuru F. Blue dye injection in the arm in order to conserve the lymphatic drainage of the arm in breast cancer patients requiring an axillary dissection. Ann Surg Oncol. 2007 Sep;14(9):2490-6. Epub 2007 Jun 5.

ReferenceCitation: Nos C, Kaufmann G, Clough KB, Collignon MA, Zerbib E, Cusumano P, Lecuru F. Combined axillary reverse mapping (ARM) technique for breast cancer patients requiring axillary dissection. Ann Surg Oncol. 2008 Sep;15(9):2550-5. doi: 10.1245/s10434-008-0030-z. Epub 2008 Jul 11.


title: Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine

acronym: KEMO

summary: This is a randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine.


title: Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation

acronym: CLAAAF

summary: The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter ablation of persistent Atrial fibrillation( pAF).

ReferenceCitation: Combes S, Jacob S, Combes N, Karam N, Chaumeil A, Guy-Moyat B, Treguer F, Deplagne A, Boveda S, Marijon E, Albenque JP. Predicting favourable outcomes in the setting of radiofrequency catheter ablation of long-standing persistent atrial fibrillation: a pilot study assessing the value of left atrial appendage peak flow velocity. Arch Cardiovasc Dis. 2013 Jan;106(1):36-43. doi: 10.1016/j.acvd.2012.09.002. Epub 2012 Dec 20.

lead_sponsor: Clinique Pasteur


summary:
The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.

Primary efficacy criteria: Apathy Inventory clinician score changes
Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes

primary_purpose: Health Services Research

lead_sponsor: Centre Hospitalier Universitaire de Nice


summary: The aim of this study is to analyze the differential expression of the miR transcriptome in the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each biopsy and the miRNA profiles will be characterized using a dedicated miR array.

primary_purpose: Basic Science

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

intervention_type: Genetic


title: A Descriptive Study of Lymphocytic Phosphorylation of ERK1/2 in Patients With Parkinson's Disease With Dyskinesias and in Controls

acronym: BIODYS (1)

summary:
Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and constitutes a debilitating complication of dopaminergic treatment in late stage. Among several neurobiological mechanisms identified so far, the investigators have established in experimental models the key role of D1 receptor hypersensitivity and a"Ras-ERK" signalling pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's Disease.

The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's Disease controls. Blood sampling "off" and "on" levodopa treatment (1 hour post-dose), as well as clinical data collection will be done during a scheduled pre-op work-up (deep brain stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled using an anti-pERK antibody and mean fluorescence intensity and percent of labelled lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will be collected "on" et "off" for dosage of dopamine. The motor effect of levodopa will be assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive oculometric recordings.

lead_sponsor: University Hospital, Bordeaux


title: Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease

acronym: POST-GPS

summary: The purpose of this study is to assess the feasibility of home-based measurement of walking capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System (GPS). This study should state if the GPS technique could be used in clinical routine in order to assess walking capacity in PAD patients. Patients will be assessed a first time (test 1) and six months later (test 2).

ReferenceCitation: Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.


primary_purpose: Supportive Care

acronym: Exacyl

title: Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens

lead_sponsor: Centre Chirurgical Marie Lannelongue

ReferenceCitation: Couturier R, Rubatti M, Credico C, Louvain-Quintard V, Anerkian V, Doubine S, Vasse M, Grassin-Delyle S. Continuous or discontinuous tranexamic acid effectively inhibits fibrinolysis in children undergoing cardiac surgery with cardiopulmonary bypass. Blood Coagul Fibrinolysis. 2014 Apr;25(3):259-65. doi: 10.1097/MBC.0000000000000051.

summary: The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.


acronym: SUF-REM-DDS

title: Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery

lead_sponsor: University Hospital, Clermont-Ferrand

summary:
Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.

The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses.


title: Effect of Dietary Supplement Limicol on LDL-cholesterol Levels in Moderate Hypercholesterolaemia

summary: The purpose of this study is to validate the effectiveness of food supplement Limicol on reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.

lead_sponsor: Lescuyer Laboratory


title: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards: a Multicenter Randomized Controlled Trial.

acronym: ATBREFEMERG

summary:
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.

OBJECTIVES: To show using a randomized trial that patients hospitalized in emergency wards with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.

METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients admitted in emergency wards:

Control group: antibiotic prescriptions will be initiated and managed by the attending physicians Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.

STUDY PROCESS: The study will took place in the emergency wards of 4 university hospitals. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.

lead_sponsor: Henri Mondor University Hospital


title: Comparison of Light-emitting Diodes (LED) Phototherapy Versus Fluorescent Lamps Phototherapy for Treatment of Hyperbilirubinemia in Term Newborn

acronym: DELF

summary: Phototherapy is almost (beside exchange transfusion) the unique treatment for hyperbilirubinemia of the newborn. Its efficacy to decrease bilirubin level (because the light interacts with bilirubin at the skin level to transform it in water soluble products eliminated in urine and stools without liver metabolism) relies on the irradiance dispensed at the skin level by the device (in the 430-490nm range) and on the exposed surface of the baby. In the past years, technology of phototherapy devices moved from fluorescent lamps to LED, improving the amount of light energy emitted but on a smaller surface. The purpose of the study is to compare the efficacy of three ramps of phototherapy, one equipped with fluorescent tubes and two with LED (in a different technological settings) in the treatment of term (35 GW or more) healthy newborn suffering hyperbilirubinemia after 2days of life.

ReferenceCitation: American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. Erratum in: Pediatrics. 2004 Oct;114(4):1138.

ReferenceCitation: Bertini G, Dani C, Pezzati M, Rubaltelli FF. Prevention of bilirubin encephalopathy. Biol Neonate. 2001;79(3-4):219-23. Review.

ReferenceCitation: Bertini G, Perugi S, Elia S, Pratesi S, Dani C, Rubaltelli FF. Transepidermal water loss and cerebral hemodynamics in preterm infants: conventional versus LED phototherapy. Eur J Pediatr. 2008 Jan;167(1):37-42. Epub 2007 Feb 13.

ReferenceCitation: Bertini G, Dani C, Tronchin M, Rubaltelli FF. Is breastfeeding really favoring early neonatal jaundice? Pediatrics. 2001 Mar;107(3):E41.

ReferenceCitation: Bhutani VK, Johnson L, Sivieri EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics. 1999 Jan;103(1):6-14.

ReferenceCitation: Bhutani VK, Johnson L. Prevention of severe neonatal hyperbilirubinemia in healthy infants of 35 or more weeks of gestation: implementation of a systems-based approach. J Pediatr (Rio J). 2007 Jul-Aug;83(4):289-93. doi: 10.2223/JPED.1673.

ReferenceCitation: Bhutani VK, Maisels MJ, Stark AR, Buonocore G; Expert Committee for Severe Neonatal Hyperbilirubinemia; European Society for Pediatric Research; American Academy of Pediatrics. Management of jaundice and prevention of severe neonatal hyperbilirubinemia in infants >or=35 weeks gestation. Neonatology. 2008;94(1):63-7. doi: 10.1159/000113463. Epub 2008 Jan 17.

ReferenceCitation: Bhutani VK, Johnson LH, Keren R. Diagnosis and management of hyperbilirubinemia in the term neonate: for a safer first week. Pediatr Clin North Am. 2004 Aug;51(4):843-61, vii. Review.

ReferenceCitation: Chang YS, Hwang JH, Kwon HN, Choi CW, Ko SY, Park WS, Shin SM, Lee M. In vitro and in vivo efficacy of new blue light emitting diode phototherapy compared to conventional halogen quartz phototherapy for neonatal jaundice. J Korean Med Sci. 2005 Feb;20(1):61-4.

ReferenceCitation: Cohen SM. Jaundice in the full-term newborn. Pediatr Nurs. 2006 May-Jun;32(3):202-8. Review.

ReferenceCitation: Grohmann K, Roser M, Rolinski B, Kadow I, Müller C, Goerlach-Graw A, Nauck M, Küster H. Bilirubin measurement for neonates: comparison of 9 frequently used methods. Pediatrics. 2006 Apr;117(4):1174-83.

ReferenceCitation: Hansen TW. Acute management of extreme neonatal jaundice--the potential benefits of intensified phototherapy and interruption of enterohepatic bilirubin circulation. Acta Paediatr. 1997 Aug;86(8):843-6.

ReferenceCitation: Lindgren C, Nilsson T. [Treatment of neonatal hyperbilirubinemia with BiliBed]. Tidsskr Nor Laegeforen. 1999 Nov 10;119(27):4027-9. Norwegian.

ReferenceCitation: Maisels MJ, Kring E. Transcutaneous bilirubin levels in the first 96 hours in a normal newborn population of > or = 35 weeks' gestation. Pediatrics. 2006 Apr;117(4):1169-73.

ReferenceCitation: Maisels MJ. What's in a name? Physiologic and pathologic jaundice: the conundrum of defining normal bilirubin levels in the newborn. Pediatrics. 2006 Aug;118(2):805-7.

ReferenceCitation: Maisels MJ, McDonagh AF. Phototherapy for neonatal jaundice. N Engl J Med. 2008 Feb 28;358(9):920-8. doi: 10.1056/NEJMct0708376. Review.

ReferenceCitation: Maisels MJ, Newman TB. Surveillance of severe neonatal hyperbilirubinemia: a view from south of the border. CMAJ. 2006 Sep 12;175(6):599.

ReferenceCitation: Newman TB, Liljestrand P, Jeremy RJ, Ferriero DM, Wu YW, Hudes ES, Escobar GJ; Jaundice and Infant Feeding Study Team. Outcomes among newborns with total serum bilirubin levels of 25 mg per deciliter or more. N Engl J Med. 2006 May 4;354(18):1889-900.

ReferenceCitation: Newman TB, Liljestrand P, Escobar GJ. Combining clinical risk factors with serum bilirubin levels to predict hyperbilirubinemia in newborns. Arch Pediatr Adolesc Med. 2005 Feb;159(2):113-9.

ReferenceCitation: Rubaltelli FF, Gourley GR, Loskamp N, Modi N, Roth-Kleiner M, Sender A, Vert P. Transcutaneous bilirubin measurement: a multicenter evaluation of a new device. Pediatrics. 2001 Jun;107(6):1264-71.

ReferenceCitation: Seidman DS, Moise J, Ergaz Z, Laor A, Vreman HJ, Stevenson DK, Gale R. A new blue light-emitting phototherapy device: a prospective randomized controlled study. J Pediatr. 2000 Jun;136(6):771-4.

ReferenceCitation: Seidman DS, Moise J, Ergaz Z, Laor A, Vreman HJ, Stevenson DK, Gale R. A prospective randomized controlled study of phototherapy using blue and blue-green light-emitting devices, and conventional halogen-quartz phototherapy. J Perinatol. 2003 Mar;23(2):123-7.

ReferenceCitation: Shapiro SM. Bilirubin toxicity in the developing nervous system. Pediatr Neurol. 2003 Nov;29(5):410-21. Review.

ReferenceCitation: Smitherman H, Stark AR, Bhutani VK. Early recognition of neonatal hyperbilirubinemia and its emergent management. Semin Fetal Neonatal Med. 2006 Jun;11(3):214-24. Review.

ReferenceCitation: Stokowski LA. Fundamentals of phototherapy for neonatal jaundice. Adv Neonatal Care. 2006 Dec;6(6):303-12. Review. Erratum in: Adv Neonatal Care. 2007 Apr;7(2):65.


acronym: ESTIM-LBH

title: Efficacy and Safety Assessment of Oral LBH589 in Adult Patients With Advanced Soft Tissue Sarcoma After Pre-treatment Failure: an Open-label, Multicenter Phase II Study

lead_sponsor: Centre Leon Berard

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ReferenceCitation: Szyf M. DNA methylation properties: consequences for pharmacology. Trends Pharmacol Sci. 1994 Jul;15(7):233-8. Review.

ReferenceCitation: Herman JG, Merlo A, Mao L, Lapidus RG, Issa JP, Davidson NE, Sidransky D, Baylin SB. Inactivation of the CDKN2/p16/MTS1 gene is frequently associated with aberrant DNA methylation in all common human cancers. Cancer Res. 1995 Oct 15;55(20):4525-30.

ReferenceCitation: Merlo A, Herman JG, Mao L, Lee DJ, Gabrielson E, Burger PC, Baylin SB, Sidransky D. 5' CpG island methylation is associated with transcriptional silencing of the tumour suppressor p16/CDKN2/MTS1 in human cancers. Nat Med. 1995 Jul;1(7):686-92.

ReferenceCitation: Herman JG, Jen J, Merlo A, Baylin SB. Hypermethylation-associated inactivation indicates a tumor suppressor role for p15INK4B. Cancer Res. 1996 Feb 15;56(4):722-7.

ReferenceCitation: Herman JG, Umar A, Polyak K, Graff JR, Ahuja N, Issa JP, Markowitz S, Willson JK, Hamilton SR, Kinzler KW, Kane MF, Kolodner RD, Vogelstein B, Kunkel TA, Baylin SB. Incidence and functional consequences of hMLH1 promoter hypermethylation in colorectal carcinoma. Proc Natl Acad Sci U S A. 1998 Jun 9;95(12):6870-5.

ReferenceCitation: Cameron EE, Baylin SB, Herman JG. p15(INK4B) CpG island methylation in primary acute leukemia is heterogeneous and suggests density as a critical factor for transcriptional silencing. Blood. 1999 Oct 1;94(7):2445-51.

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ReferenceCitation: Lin RJ, Nagy L, Inoue S, Shao W, Miller WH Jr, Evans RM. Role of the histone deacetylase complex in acute promyelocytic leukaemia. Nature. 1998 Feb 19;391(6669):811-4.

ReferenceCitation: Redner RL, Wang J, Liu JM. Chromatin remodeling and leukemia: new therapeutic paradigms. Blood. 1999 Jul 15;94(2):417-28. Review.

ReferenceCitation: Yoshida M, Nomura S, Beppu T. Effects of trichostatins on differentiation of murine erythroleukemia cells. Cancer Res. 1987 Jul 15;47(14):3688-91.

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ReferenceCitation: Itazaki H, Nagashima K, Sugita K, Yoshida H, Kawamura Y, Yasuda Y, Matsumoto K, Ishii K, Uotani N, Nakai H, et al. Isolation and structural elucidation of new cyclotetrapeptides, trapoxins A and B, having detransformation activities as antitumor agents. J Antibiot (Tokyo). 1990 Dec;43(12):1524-32.

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ReferenceCitation: Medina V, Edmonds B, Young GP, James R, Appleton S, Zalewski PD. Induction of caspase-3 protease activity and apoptosis by butyrate and trichostatin A (inhibitors of histone deacetylase): dependence on protein synthesis and synergy with a mitochondrial/cytochrome c-dependent pathway. Cancer Res. 1997 Sep 1;57(17):3697-707.

ReferenceCitation: Biggs JR, Kudlow JE, Kraft AS. The role of the transcription factor Sp1 in regulating the expression of the WAF1/CIP1 gene in U937 leukemic cells. J Biol Chem. 1996 Jan 12;271(2):901-6.

ReferenceCitation: Nakano K, Mizuno T, Sowa Y, Orita T, Yoshino T, Okuyama Y, Fujita T, Ohtani-Fujita N, Matsukawa Y, Tokino T, Yamagishi H, Oka T, Nomura H, Sakai T. Butyrate activates the WAF1/Cip1 gene promoter through Sp1 sites in a p53-negative human colon cancer cell line. J Biol Chem. 1997 Aug 29;272(35):22199-206.

ReferenceCitation: Sowa Y, Orita T, Minamikawa S, Nakano K, Mizuno T, Nomura H, Sakai T. Histone deacetylase inhibitor activates the WAF1/Cip1 gene promoter through the Sp1 sites. Biochem Biophys Res Commun. 1997 Dec 8;241(1):142-50.

ReferenceCitation: Sambucetti LC, Fischer DD, Zabludoff S, Kwon PO, Chamberlin H, Trogani N, Xu H, Cohen D. Histone deacetylase inhibition selectively alters the activity and expression of cell cycle proteins leading to specific chromatin acetylation and antiproliferative effects. J Biol Chem. 1999 Dec 3;274(49):34940-7.

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ReferenceCitation: Edmonson JH, Ryan LM, Blum RH, Brooks JS, Shiraki M, Frytak S, Parkinson DR. Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol. 1993 Jul;11(7):1269-75.

ReferenceCitation: Santoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45.

ReferenceCitation: Prince HM, George DJ, Johnstone R, Williams-Truax R, Atadja P, Zhao C et al. LBH589, a novel histone deacetylase inhibitor (HDACi), treatment of patients with cutaneous T-cell lymphoma (CTCL). Changes in skin gene expression profiles related to clinical response following therapy. J Clin Oncol (Meeting Abstracts) 2006;24:7501.

ReferenceCitation: Beck J, Fischer T, George D, Huber C, Calvo E, Atadja P et al. Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of ORAL LBH589B: A novel histone deacetylase (HDAC) inhibitor. J Clin Oncol (Meeting Abstracts) 2005;23:3148.

ReferenceCitation: Beck J, Fischer T, Rowinsky E, Huber C, Mita M, Atadja P et al. Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of LBH589A: A novel histone deacetylase inhibitor. J Clin Oncol (Meeting Abstracts) 2004;22:3025.

ReferenceCitation: Le Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, Van Hoesel Q, Blay JY, Frisch J, Van Glabbeke M, Hermans C, Van Oosterom A, Tursz T, Verweij J. Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 2000 Jul;18(14):2676-84.

ReferenceCitation: Garcia-Carbonero R, Supko JG, Manola J, Seiden MV, Harmon D, Ryan DP, Quigley MT, Merriam P, Canniff J, Goss G, Matulonis U, Maki RG, Lopez T, Puchalski TA, Sancho MA, Gomez J, Guzman C, Jimeno J, Demetri GD. Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J Clin Oncol. 2004 Apr 15;22(8):1480-90.

ReferenceCitation: Le Cesne A, Blay JY, Judson I, Van Oosterom A, Verweij J, Radford J, Lorigan P, Rodenhuis S, Ray-Coquard I, Bonvalot S, Collin F, Jimeno J, Di Paola E, Van Glabbeke M, Nielsen OS. Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. J Clin Oncol. 2005 Jan 20;23(3):576-84. Erratum in: J Clin Oncol. 2005 Aug 1;23(22):5276.

ReferenceCitation: Bay JO, Ray-Coquard I, Fayette J, Leyvraz S, Cherix S, Piperno-Neumann S, Chevreau C, Isambert N, Brain E, Emile G, Le Cesne A, Cioffi A, Kwiatkowski F, Coindre JM, Bui NB, Peyrade F, Penel N, Blay JY; Groupe Sarcome Français. Docetaxel and gemcitabine combination in 133 advanced soft-tissue sarcomas: a retrospective analysis. Int J Cancer. 2006 Aug 1;119(3):706-11. Erratum in: Int J Cancer. 2007 Jan 15;120(2):450. Penel, Nicolas [added].

ReferenceCitation: Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31.

ReferenceCitation: Bolden JE, Peart MJ, Johnstone RW. Anticancer activities of histone deacetylase inhibitors. Nat Rev Drug Discov. 2006 Sep;5(9):769-84. Review.

ReferenceCitation: Ito T, Ouchida M, Ito S, Jitsumori Y, Morimoto Y, Ozaki T, Kawai A, Inoue H, Shimizu K. SYT, a partner of SYT-SSX oncoprotein in synovial sarcomas, interacts with mSin3A, a component of histone deacetylase complex. Lab Invest. 2004 Nov;84(11):1484-90.

ReferenceCitation: Wunder JS, Nielsen TO, Maki RG, O'Sullivan B, Alman BA. Opportunities for improving the therapeutic ratio for patients with sarcoma. Lancet Oncol. 2007 Jun;8(6):513-24. Review. Erratum in: Lancet Oncol. 2007 Aug;8(8):670.

ReferenceCitation: Kutko MC, Glick RD, Butler LM, Coffey DC, Rifkind RA, Marks PA, Richon VM, LaQuaglia MP. Histone deacetylase inhibitors induce growth suppression and cell death in human rhabdomyosarcoma in vitro. Clin Cancer Res. 2003 Nov 15;9(15):5749-55.

ReferenceCitation: Sakimura R, Tanaka K, Nakatani F, Matsunobu T, Li X, Hanada M, Okada T, Nakamura T, Matsumoto Y, Iwamoto Y. Antitumor effects of histone deacetylase inhibitor on Ewing's family tumors. Int J Cancer. 2005 Sep 20;116(5):784-92.

ReferenceCitation: Prince HM, George D, Patnaik A, Mita M, Dugan M, Butterfoss D et al. Phase I study of oral LBH589, a novel deacetylase (DAC) inhibitor in advanced solid tumors and non-hodgkin's lymphoma. J Clin Oncol (Meeting Abstracts) 2007;25:3500. 66. A'Hern RP. Sample

ReferenceCitation: A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66.

ReferenceCitation: Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.

ReferenceCitation: Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.

ReferenceCitation: van Maldegem AM, Bovée JV, Gelderblom H. Panobinostat-A Potential Treatment for Metastasized Ewing Sarcoma? A Case Report. Pediatr Blood Cancer. 2016 Oct;63(10):1840-3. doi: 10.1002/pbc.26077. Epub 2016 Jun 1.

ReferenceCitation: Cassier PA, Lefranc A, Amela EY, Chevreau C, Bui BN, Lecesne A, Ray-Coquard I, Chabaud S, Penel N, Berge Y, Dômont J, Italiano A, Duffaud F, Cadore AC, Polivka V, Blay JY. A phase II trial of panobinostat in patients with advanced pretreated soft tissue sarcoma. A study from the French Sarcoma Group. Br J Cancer. 2013 Aug 20;109(4):909-14. doi: 10.1038/bjc.2013.442. Epub 2013 Aug 6.

summary: The purpose of this study is to assess efficacy and safety of LBH589 - Panobinostat®, a potent HDACi, in patients with advanced STS who experiment disease progression after or during first-line chemotherapy. The rational is based on the observation of activity of deacetylase inhibitor (DACi) in several pre-clinical models of STS including Synovial sarcoma and Ewing sarcoma.


acronym: Oberab

summary: This study aims to determine, in obese subjects, the antisecretory effect of a single dose of placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days. The main outcome criteria of analysis is the percentage of time with gastric pH above 3 during 24hours.

ReferenceCitation: Belhocine K, Vavasseur F, Volteau C, Flet L, Touchefeu Y, Bruley des Varannes S. Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole. BMC Gastroenterol. 2014 Jul 15;14:128. doi: 10.1186/1471-230X-14-128.


title: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.

acronym: ATBREFSURMED

summary:
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.

OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.

METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients:

Control group: antibiotic prescriptions will be initiated and managed by the attending physicians
Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.

STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical wards will participate by hospital. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.

ReferenceCitation: Lesprit P, de Pontfarcy A, Esposito-Farese M, Ferrand H, Mainardi JL, Lafaurie M, Parize P, Rioux C, Tubach F, Lucet JC. Postprescription review improves in-hospital antibiotic use: a multicenter randomized controlled trial. Clin Microbiol Infect. 2015 Feb;21(2):180.e1-7. doi: 10.1016/j.cmi.2014.08.015. Epub 2014 Oct 14.


title: Cardiac MRI for the Detection of Cellular Rejection in Patients With Heart Transplantation

summary: To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant in childhood.


acronym: R-GVHD

title: Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab

ReferenceCitation: Malard F, Labopin M, Yakoub-Agha I, Chantepie S, Guillaume T, Blaise D, Tabrizi R, Magro L, Vanhove B, Blancho G, Moreau P, Gaugler B, Chevallier P, Mohty M. Rituximab-based first-line treatment of cGVHD after allogeneic SCT: results of a phase 2 study. Blood. 2017 Nov 16;130(20):2186-2195. doi: 10.1182/blood-2017-05-786137. Epub 2017 Sep 1.

summary: The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.


title: Role of the Cortico-basal Ganglia Loops in Visual Attention: Effects of Dopaminergic and Subthalamic Nucleus Stimulation in Parkinson's Disease

acronym: VSA-PD

summary:
Parkinson's disease (PD), which is generally considered to be a motor disorder, is now known to be accompanied in many instances by a variety of cognitive defects. This can be explained considering that PD is a neurodegenerative and progressive disorder of the basal ganglia system, which works modulating not only motor, but also cognitive and emotional behaviours.

Concerning this, some studies suggest that non-demented PD patients may suffer from a voluntary selective visual attention orienting deficit, showing a reduced skill in focusing upon one target, and may be easily distracted from irrelevant but salient stimuli, with a consequent negative impact on their physical health, social interactions and quality of life.

Up to now, the evidence of the role of the basal-ganglia system in modulating visual attention functions is poor and indirect and the effects of dopaminergic and subthalamic nucleus (STN) stimulation (two usual and effective treatments in PD) on attention performances are controversial.

The main objectives of the project are: 1) to assess the visual selective attention as well as the distractibility in PD patients; 2) to study the effects of patient's usual antiparkinsonian treatments, that is dopaminergic and STN stimulation, on visual attention performances.

Secondly, from a clinical and neurophysiologic point of view, the investigators want to study the respective role of the dopaminergic pathways and the sensorimotor and associative/limbic cortico-basal ganglia loops passing across the STN in the visual attention performances.

To precisely answer the objectives of the protocol, the investigators will record the performances of participants during the administration of 3 computerized tests, which are suitable to study visual attention, decision making and motor performances.

The investigators will compare the performances on the computerized tests of two groups of PD patients, one evaluated in different sets of electrical (without stimulation, or selective stimulation of the sensorimotor or associative/limbic part of the STN) stimulation, the other in different conditions of medication (with or without dopaminergic treatment) with those of a group of healthy subjects.

lead_sponsor: University Hospital, Grenoble

location_facility: Unité des Troubles du Mouvement, Clinique de Neurologie, Grenoble University Hospital


title: Assessment of Quality of Life in Disorders of the Pelvic Floor

acronym: U-GYN-QOL

summary: The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


title: A Phase 1/2, Open Label Study in Men With Prostate Cancer to Assess the Safety. Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448, Administered as a 1-Month Depot, Including a Randomized Portion With a Group Administered Leuprorelin

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_facility: Hôpital Edouard Herriot, 5, Place d'Arsonval, Pavillon V - Urologie et chirurgie de la transplantation

summary: The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of 1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The phase 2 portion of this study is an open-label, multicenter, randomized study in men with prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)- lowering potential of up to 2 dose levels of 1-month depot TAK-448.


title: A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo

acronym: AZD6765 EEG

summary: This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.

ReferenceCitation: Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.

lead_sponsor: AstraZeneca


title: Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)

acronym: ABOS

summary:
Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment interactions. However, this interaction, as well as the specific effect of each polymorphism, remains poorly understood.

We now proposed a prospective cohort study to improve our understanding of the influence of phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid metabolism by collecting different biological samples.

status: Recruiting

ReferenceCitation: Margerie D, Lefebvre P, Raverdy V, Schwahn U, Ruetten H, Larsen P, Duhamel A, Labreuche J, Thuillier D, Derudas B, Gheeraert C, Dehondt H, Dhalluin Q, Alexandre J, Caiazzo R, Nesslany P, Verkindt H, Pattou F, Staels B. Hepatic transcriptomic signatures of statin treatment are associated with impaired glucose homeostasis in severely obese patients. BMC Med Genomics. 2019 Jun 3;12(1):80. doi: 10.1186/s12920-019-0536-1.

ReferenceCitation: Lien F, Berthier A, Bouchaert E, Gheeraert C, Alexandre J, Porez G, Prawitt J, Dehondt H, Ploton M, Colin S, Lucas A, Patrice A, Pattou F, Diemer H, Van Dorsselaer A, Rachez C, Kamilic J, Groen AK, Staels B, Lefebvre P. Metformin interferes with bile acid homeostasis through AMPK-FXR crosstalk. J Clin Invest. 2014 Mar;124(3):1037-51. doi: 10.1172/JCI68815. Epub 2014 Feb 17.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

status_simplified: Ongoing


title: An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects

summary:
The objectives of the study are to:

Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

lead_sponsor: Sanofi


summary:
Beta amyloid immunoreactivity is probably due to a significant number of Ab catabolites corresponding to N-terminally truncated and Cterminally truncated or extended forms which display distinct propensity to aggregation. Very few things are known concerning the mechanisms and proteases by which they are generated. Furthermore, the link between truncation and toxicity has not been delineated.

Finally, little is known concerning Ab fragments in biological fluids and whether they could be seen as early biomarkers and thereby, as putative targets for AD diagnostic. The present project will allow to examine the human biological samples and to identify various cohorts after complete clinical evaluation.


title: A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease

lead_sponsor: Shire

ReferenceCitation: Ureña-Torres P, Prié D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.

summary: To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.


summary: Land military missions generally combine prolonged walking/moderate-pace-running and other physical actions such as creeping, jumping, shooting,… which are associated with the direct carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers. For an infantry section, "typical" intervention phases last about 20-24 h and combine variable intensity grades. Consequently, military mission characteristics are an interesting investigation field of human fatigue. Previous studies have investigated human neuromuscular alterations after prolonged "normal" locomotion exercises [Millet et al., 2004, 2009], thus the aim of this study is to characterize the neuromuscular determinants of fatigue induced by a 24-h Simulated Military Effort (SME) and a 4-h Military Road March (MM), both performed with high load carriage. Additionally, the consequences of fatigue on physiological and biomechanical parameters of locomotion will be investigated.

ReferenceCitation: Grenier JG, Millet GY, Peyrot N, Samozino P, Oullion R, Messonnier L, Morin JB. Effects of extreme-duration heavy load carriage on neuromuscular function and locomotion: a military-based study. PLoS One. 2012;7(8):e43586. doi: 10.1371/journal.pone.0043586. Epub 2012 Aug 22.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration

acronym: ARIBA

summary:
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension.

In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy.

Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.

ReferenceCitation: Greau E, Lascarrou JB, Le Thuaut A, Maquigneau N, Alcourt Y, Coutolleau A, Rousseau C, Erragne V, Reignier J. Automatic versus manual changeovers of norepinephrine infusion pumps in critically ill adults: a prospective controlled study. Ann Intensive Care. 2015 Dec;5(1):40. doi: 10.1186/s13613-015-0083-7. Epub 2015 Nov 14.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

acronym: LIP-RE-I

summary: This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.

ReferenceCitation: Garin E, Rakotonirina H, Lejeune F, Denizot B, Roux J, Noiret N, Mesbah H, Herry JY, Bourguet P, Lejeune JJ. Effect of a 188 Re-SSS lipiodol/131I-lipiodol mixture, 188 Re-SSS lipiodol alone or 131I-lipiodol alone on the survival of rats with hepatocellular carcinoma. Nucl Med Commun. 2006 Apr;27(4):363-9.

lead_sponsor: Center Eugene Marquis


title: Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisatnce Publique Hopitaux de Marseille

summary: The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.


title: Secondary Adult's Hemophagocytic Lymphohistiocytosis and Innate Immunity

summary:
Hemophagocytic lymphohisticytosis (HLH) is a rare and severe disease of genetic origin in children (familial-HLH, F-HLH) or affecting adults secondary to infections, hematologic malignancies or auto-immune diseases (secondary_HLH, S-HLH). F-HLH are due to genetic mutations affecting the genes of perforin or proteins involved in its secretion, resulting in the complete loss of lymphocyte cytotoxicity without affecting lymphocyte number. In S-HLH, the investigators have observed a severe NK cell lymphopenia and a transient loss of cytotoxicity of unknown mechanism. In this study, the investigators will dissect macrophage activation mechanisms as well as NK cytotoxicity inability in adults patients suffering of S-HLH.

Macrophage activation could result from the loss of the retro-control normally exerted by NK cells, thus the investigators will analyze reciprocal interactions of macrophages and NK cells during the acute phase and after recovery of S-HLH.

location_facility: Assistance Publique Hopitaux de Marseille


title: Head to Head Comparison of Multidetector Coronary Tomography and Conventional Coronary Angiogram in the Setting of Systematic Screening of Coronary Vasculopathy After Orthotopic Heart Transplantation.

summary: Coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation. It is mainly asymptomatic because of the denervation of the heart transplant. Currently, annual invasive coronary angiogram is performed to ensure the lack of coronary narrowing. But invasive coronary angiography caries risks of serious adverse events and some concern rise from its repetition in that population. Recent advance in coronary multidetector computed tomography (CT) may allow non invasive visualization of the coronary tree. But, it remains unknown if the encouraging data observed in native coronary artery analysis can be extrapolated to transplant heart recipients. Indeed, only very small sample size studies (20 patients) have been conducted in this particular setting. Thus, the investigators decide to assess the diagnostic accuracy of the 64-row CT and 256-row CT compared to the gold standard coronary angiogram in a larger sample size study. The practice aim of this study is to determine if the conventional invasive coronarography can be switched by the 64-row CT or the 256-row CT to assess coronary anatomy especially for the patient without any coronary artery disease (CAD) or those with CAD not suitable for percutaneous coronary intervention.

lead_sponsor: French Cardiology Society


title: Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

acronym: NESAKI

summary:
Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more effectively and faster than serum creatinine and urea levels.

The purpose of this study is to take a blood sample from patients at admission and then at 24 and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine and urea.

lead_sponsor: Université Victor Segalen Bordeaux 2

location_facility: Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital


title: Comparative Efficacy and Safety of Combined Radiotherapy and Adjuvant Hormone Therapy (Leuprorelin SR 11.25 mg) and Hormone Therapy Alone (Leuprorelin SR 11.25 mg) in Locally Advanced Prostate Cancer (T3-T4 or pT3 on Biopsy, N0, M0)

summary: The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).

ReferenceCitation: Sargos P, Mottet N, Bellera C, Richaud P. Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial. BJU Int. 2020 Jun;125(6):810-816. doi: 10.1111/bju.14768. Epub 2020 Mar 2.

lead_sponsor: Takeda

intervention_type: Radiation


title: Impact of Oral Magnesium on Neuropathic Pain

summary:
Use lay language.

The aim of this study is to evaluate on pain scores (neuropathic pain questionnaire and pain numeric scale) and on quality of life, the effect of oral magnesium intake on patients with neuropathic pain comparing with patients receiving placebo,. The study drug will be taken during 4 weeks.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.

acronym: COLIBIS

summary: Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Physiopathology of Rapid Aspirin Desensitization in Patients With Coronary Artery Disease and a History of Hypersensitivity to Aspirin or NSAIDs

summary: Aspirin is very effective in protecting patients with coronary artery disease against adverse cardiac events, because it is a potent "antiplatelet agent". Some patients may develop a history of hypersensitivity to aspirin and treatment cannot usually be resumed in these patients. We have developed a rapid procedure to induce tolerance in these patients (SILBERMAN et al, Am J CARDIOL 2005;95:509-10) and wish to test whether aspirin is as effective as antiplatelet agent in patients with a history of allergy to aspirin and who undergo desensitization as it is in patients without history of hypersensitivity

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre hospitalier Bichat Claude Bernard