title: Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer.

acronym: DOPMET

summary: Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA), is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent MTC without evidence of recurrence or metastases on several imaging modalities.


title: Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.

acronym: SOREVAS

summary: Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. The major aim of our study is to examine the effect of CPAP treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology

summary: In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the preparation of the painful procedures of a short duration such as spinal taps or osseous at the adult.The objective of this study thus is to clarify the appropriate efficiency and the tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures realized in adult oncology with regard to the analgesic reference methods and to the effect placebo leads by the accompaniment of the patient during the procedure.

status: Completed

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Air Liquide Santé International

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Cardiovascular Evaluation of a Rare Condition With Hyperaldosteronism Without Hypertension: PHA 1

acronym: PHACARV

summary: Vascular and cardiac alterations are associated with aldosterone effects are evidenced in experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease (heart failure). The study aims at assessing vascular and cardiac alterations in adults with a chronic increase in circulating aldosterone without hypertension. The investigated population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to heterozygous inactivating mutations of the mineralocorticoid receptor.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Pujo L, Fagart J, Gary F, Papadimitriou DT, Claës A, Jeunemaître X, Zennaro MC. Mineralocorticoid receptor mutations are the principal cause of renal type 1 pseudohypoaldosteronism. Hum Mutat. 2007 Jan;28(1):33-40.

ReferenceCitation: Sacré K, Brihaye B, Hyafil F, Serfaty JM, Escoubet B, Zennaro MC, Lidove O, Laissy JP, Papo T. Asymptomatic myocardial ischemic disease in antiphospholipid syndrome: a controlled cardiac magnetic resonance imaging study. Arthritis Rheum. 2010 Jul;62(7):2093-100. doi: 10.1002/art.27488.

ReferenceType: derived

ReferenceCitation: Escoubet B, Couffignal C, Laisy JP, Mangin L, Chillon S, Laouénan C, Serfaty JM, Jeunemaitre X, Mentré F, Zennaro MC. Cardiovascular effects of aldosterone: insight from adult carriers of mineralocorticoid receptor mutations. Circ Cardiovasc Genet. 2013 Aug;6(4):381-90. doi: 10.1161/CIRCGENETICS.113.000115. Epub 2013 Jul 14.


title: Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome

summary:
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.

Precisely, the study was designed to :

evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
determine the sensitivity and specificity of the device in adequately detecting respiratroy events
compare effective pressure Peff determined by the device and during manual titration
compare the impact of the two-speed descent pressure algorithm

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Tyco Healthcare Group

location_facility: Hospital Michalon, sleep disorders center


title: Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

summary: Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. To investigate the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters of patients with metabolic neuropathies.

lead_sponsor: Henri Mondor University Hospital

intervention_type: Behavioral


title: Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control

summary: The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.


title: Evaluation of the Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet Rich in Fruits and Vegetables, on the Evolution of Body Fat in Overweight or Obese Women, as Part of Type 2 Diabetes Prevention in Reunion Island.

acronym: LIPOXmax-RUN

summary: The purpose of this study is to evaluate the efficacy of 3 of physical exercise training programs, with a supplementation in fruits and vegetables, on body composition. 126 women will be randomized into 3 groups (42 subjects per group). The first program will be conducted at a relatively low intensity of effort, corresponding to the maximum rate of lipid oxidation (LIPOXmax)measured by indirect calorimetry. The second program will be at 60% of VO2peak and the third program will be prescribed according to the Good Practices physical Guidelines (30 minutes per day at a moderate intensity). All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 5 months in total.

primary_purpose: Prevention

ReferenceCitation: Besnier F, Lenclume V, Gérardin P, Fianu A, Martinez J, Naty N, Porcherat S, Boussaid K, Schneebeli S, Jarlet E, Hatia S, Dalleau G, Verkindt C, Brun JF, Gonthier MP, Favier F. Individualized Exercise Training at Maximal Fat Oxidation Combined with Fruit and Vegetable-Rich Diet in Overweight or Obese Women: The LIPOXmax-Réunion Randomized Controlled Trial. PLoS One. 2015 Nov 10;10(11):e0139246. doi: 10.1371/journal.pone.0139246. eCollection 2015.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

intervention_type: Dietary Supplement


title: Effect on Hemodynamics of Automated Band Chest Compression Device in Cardiac Arrest Resuscitation

summary: To evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures are expected.

time_perspective: Prospective

lead_sponsor: Beaujon Hospital

location_facility: Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital


type: EudraCT Number

title: A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.

summary: This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.

lead_sponsor: Hoffmann-La Roche


title: Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora

acronym: AlimIntest

summary: The main objective of the study is to realized a collection of feces in order to study the modification of the intestinal microflora according to alimentary fibres

primary_purpose: Basic Science

ReferenceCitation: Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Doré J. Direct analysis of genes encoding 16S rRNA from complex communities reveals many novel molecular species within the human gut. Appl Environ Microbiol. 1999 Nov;65(11):4799-807.

ReferenceCitation: Aaltonen LA, Peltomäki P, Leach FS, Sistonen P, Pylkkänen L, Mecklin JP, Järvinen H, Powell SM, Jen J, Hamilton SR, et al. Clues to the pathogenesis of familial colorectal cancer. Science. 1993 May 7;260(5109):812-6.

ReferenceCitation: Moore WE, Moore LH. Intestinal floras of populations that have a high risk of colon cancer. Appl Environ Microbiol. 1995 Sep;61(9):3202-7.

ReferenceCitation: Black AE, Coward WA, Cole TJ, Prentice AM. Human energy expenditure in affluent societies: an analysis of 574 doubly-labelled water measurements. Eur J Clin Nutr. 1996 Feb;50(2):72-92.

ReferenceCitation: Robinson RR, Feirtag J, Slavin JL. Effects of dietary arabinogalactan on gastrointestinal and blood parameters in healthy human subjects. J Am Coll Nutr. 2001 Aug;20(4):279-85.

ReferenceCitation: Tuohy KM, Kolida S, Lustenberger AM, Gibson GR. The prebiotic effects of biscuits containing partially hydrolysed guar gum and fructo-oligosaccharides--a human volunteer study. Br J Nutr. 2001 Sep;86(3):341-8.

ReferenceCitation: Chinda D, Nakaji S, Fukuda S, Sakamoto J, Shimoyama T, Nakamura T, Fujisawa T, Terada A, Sugawara K. The fermentation of different dietary fibers is associated with fecal clostridia levels in men. J Nutr. 2004 Aug;134(8):1881-6.

lead_sponsor: University Hospital, Grenoble


type: Other Identifier

title: Evaluation of Psychological Defense Mechanisms Used by Liver Transplant Patients on Their Somatic Psychological and Social Outcome. Research for Protective or Vulnerability Factors.

acronym: GHEPA

summary:
Organ transplantation has a special place in the medical field. It symbolizes a medicine whose limits always seem to be repelled. Because transplantation is unusual, it places people in front of outstanding issues which he has to cope with his personality and history. Factors involved in the psychology of patient presenting with graft are past and present psychic functioning, object relations, experience of transplantation itself and quality of social environment.

Before or after graft defense mechanisms can be so intense that they can make the patient unable to overcome the graft. Yet as a pathological mechanism that denial was considered beneficial provided it is short.

The aim of this study is to evaluate on psychopathological influence of psychological defense mechanisms used by liver transplant patients on their somatic psychological and social outcome.

lead_sponsor: University Hospital, Lille


title: Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.

acronym: TALOS

summary: The aim of our study is to determine the most efficient radiologic examination to assess the ankle sprain seriousness and so improve the therapeutic care.

ReferenceCitation: Picard F, Tourné Y, Montbarbon E, Saragaglia D. [Ankle trauma. Diagnostic orientation]. Rev Prat. 1995 Nov 15;45(18):2335-42. French.

ReferenceCitation: Braun BL. Effects of ankle sprain in a general clinic population 6 to 18 months after medical evaluation. Arch Fam Med. 1999 Mar-Apr;8(2):143-8.

ReferenceCitation: Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. Review. French.

ReferenceCitation: Raatikainen T, Putkonen M, Puranen J. Arthrography, clinical examination, and stress radiograph in the diagnosis of acute injury to the lateral ligaments of the ankle. Am J Sports Med. 1992 Jan-Feb;20(1):2-6.

ReferenceCitation: Brasseur JL, Morvan G, Godoc B. [Dynamic ultrasonography]. J Radiol. 2005 Dec;86(12 Pt 2):1904-10. Review. French.

ReferenceCitation: Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41.

location_facility: Emergency department - University Hospital of Grenoble South

intervention_type: Other


title: Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention

acronym: VEDROP

summary: To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the classical lipid-soluble form in a population of patients with intestinal malabsorption (hypocholesterolemias family by retention of chylomicrons).

lead_sponsor: Hospices Civils de Lyon

location_facility: Hopital Femme Mere Enfant-Hospices Civils de Lyon


summary: Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.

lead_sponsor: Sanofi


title: Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome

acronym: JOQUER

summary:
Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done.

Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales.

ReferenceCitation: Gottenberg JE, Ravaud P, Puéchal X, Le Guern V, Sibilia J, Goeb V, Larroche C, Dubost JJ, Rist S, Saraux A, Devauchelle-Pensec V, Morel J, Hayem G, Hatron P, Perdriger A, Sene D, Zarnitsky C, Batouche D, Furlan V, Benessiano J, Perrodeau E, Seror R, Mariette X. Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial. JAMA. 2014 Jul 16;312(3):249-58. doi: 10.1001/jama.2014.7682.


title: First Line Mantle Cell Lymphoma (MCL) Treatment by RiBVD Schema in Patients Older Than 65 Years or 18 to 65 Years Old Who Cannot or Refuse Receive Conditioning Regimen Followed by Autograft

acronym: RIBVD

summary: Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.

ipd_sharing: No

lead_sponsor: French Innovative Leukemia Organisation


title: Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.

acronym: NEUROHD

summary: Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in average (with high variability) in the fourth decade. The disease progression is classically characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining depression and irritability) and metabolic disorder (cachexia). The disease is fatal within 15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also beneficial and adverse effects on other disease characteristics (motor, psychiatric, cognitive or metabolic). Their profile between beneficial and adverse effects could be different according the neuroleptics and their classification. The aim of this study is to compare beneficial and adverse effects of 3 different neuroleptics in HD.

study_start_date_type: Actual


title: A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia

acronym: PRIMAL

summary: This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia .


title: Evaluation of the Efficacy of "MEOPA" Used to Obtain Better ROM Immediately After Multilevel Surgery in Children With Spastic Diplegia, Quadriplegia or Hemiplegia.

acronym: KINOPA

summary: Children with cerebral palsy commonly undergo "multilevel surgery", meaning several lower limb combined procedures performed during the same surgical intervention. The aim of this type of surgery is to correct all deformities together in order to restore near to normal anatomy and muscular function. It is very important to be able to obtain good range of motion after surgery, in order to consolidate surgical results. During the first days after the operation, children are sore and it may be difficult to realize adequate physical therapy. In order to palliate this situation, MEOPA gaz is used during REHAB sessions. Good results have been obtained so far but no study is available to demonstrate these results. The goal of our research is to prove that there is a benefit in using MEOPA postoperatively in these patients.

ReferenceCitation: Delafontaine A, Presedo A, Mohamed D, Lopes D, Wood C, Alberti C. Equimolar mixture of nitroux oxyde and oxygen during post-operative physiotherapy in patients with cerebral palsy: A randomized, double-blind, placebo-controlled study. Eur J Pain. 2017 Nov;21(10):1657-1667. doi: 10.1002/ejp.1071. Epub 2017 Jul 20.


title: Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)

acronym: EPIPOD

summary: Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and strategies have significantly evolved during these last years, influenced by Baker nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity and cardio-vascular pathology prevalence in this target population at adulthood. In this context many studies emerged since 2000 and try to assess the trade-off between neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between heterogenous proteic input dispensed in our NICU (described by tercil methods on population) and fat mass phenotype variations at discharge (described by tercil methods); and its consequences on neurodevelopmental growth. Understanding how particular nutritional exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main goal.

ReferenceCitation: Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Rozé JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.

lead_sponsor: Nantes University Hospital


title: Evaluation Of The Efficacy, Tolerance And Acceptability Of URGO Dressing 310 3082 Versus A Hydrofibre Dressing In The Local Management Of Venous Or Predominantly Venous Mixed Leg Ulcers

summary: The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.

lead_sponsor: Laboratoires URGO


title: Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion

acronym: ALCOOTAX

summary: The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.

lead_sponsor: Institut Curie


title: Randomized Strategy Trial Comparing Detection of Silent Ischemia With no Detection of Silent Ischemia in Asymptomatic Patients With Type 2 Diabetes Mellitus. Effects on Cardiovascular Events.

acronym: DYNAMIT

summary: DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors are randomized to screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316), or follow-up without screening (N=315). All have access to cardiovascular prevention according current guidelines. The main end point is time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention.

ReferenceCitation: Lièvre MM, Moulin P, Thivolet C, Rodier M, Rigalleau V, Penfornis A, Pradignac A, Ovize M; DYNAMIT investigators. Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening. Trials. 2011 Jan 26;12:23. doi: 10.1186/1745-6215-12-23.


title: Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort

summary: The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum (PXE) disease in various tissues (eye, skin, arteries, etc).

ReferenceCitation: Naouri M, Boisseau C, Bonicel P, Daudon P, Bonneau D, Chassaing N, Martin L. Manifestations of pseudoxanthoma elasticum in childhood. Br J Dermatol. 2009 Sep;161(3):635-9. doi: 10.1111/j.1365-2133.2009.09298.x. Epub 2009 Jun 9.

ReferenceCitation: Martin L, Maître F, Bonicel P, Daudon P, Verny C, Bonneau D, Le Saux O, Chassaing N. Heterozygosity for a single mutation in the ABCC6 gene may closely mimic PXE: consequences of this phenotype overlap for the definition of PXE. Arch Dermatol. 2008 Mar;144(3):301-6. doi: 10.1001/archderm.144.3.301.

ReferenceCitation: Bière L, Donal E, Terrien G, Furber A, Martin L, Prunier F. Left ventricular function in a large cohort of pseudoxanthoma elasticum patients. PLoS One. 2014 Mar 20;9(3):e90364. doi: 10.1371/journal.pone.0090364. eCollection 2014.

lead_sponsor: University Hospital, Angers


title: Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.

PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

lead_sponsor: Groupe D'Etude des Tumeurs Uro-Genitales


title: recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients

acronym: Alloforb

summary: The usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists of intensification of systemic immunosuppressive therapy.

ReferenceCitation: Bergeron A, Belle A, Chevret S, Ribaud P, Devergie A, Esperou H, Ades L, Gluckman E, Socié G, Tazi A. Combined inhaled steroids and bronchodilatators in obstructive airway disease after allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 May;39(9):547-53. Epub 2007 Mar 12.

ReferenceCitation: Bergeron A, Chevret S, Chagnon K, Godet C, Bergot E, Peffault de Latour R, Dominique S, de Revel T, Juvin K, Maillard N, Reman O, Contentin N, Robin M, Buzyn A, Socié G, Tazi A. Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2015 Jun 1;191(11):1242-9. doi: 10.1164/rccm.201410-1818OC.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of the Temporospatial Gait Parameters With the Electronic Carpet "GAITRite" in Patients With Walking Impairment After Stroke and in Old Faller Subjects

acronym: GAITRITE

summary: A large proportion of falls in older people occurs when walking. Most studies have recently demonstrated correlation between the variations in spatiotemporal gait parameters and fall risk in elderly and in several diseases. The investigators objective is to analyse this parameters in population with gait stability disorders (post-stroke patients and fallers) to identify the most valuable and to develop/test a conglomerate stability score.

ReferenceCitation: Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6.

ReferenceCitation: Hausdorff JM, Nelson ME, Kaliton D, Layne JE, Bernstein MJ, Nuernberger A, Singh MA. Etiology and modification of gait instability in older adults: a randomized controlled trial of exercise. J Appl Physiol (1985). 2001 Jun;90(6):2117-29.

ReferenceCitation: Bilney B, Morris M, Webster K. Concurrent related validity of the GAITRite walkway system for quantification of the spatial and temporal parameters of gait. Gait Posture. 2003 Feb;17(1):68-74.

ReferenceCitation: Menz HB, Latt MD, Tiedemann A, Mun San Kwan M, Lord SR. Reliability of the GAITRite walkway system for the quantification of temporo-spatial parameters of gait in young and older people. Gait Posture. 2004 Aug;20(1):20-5.

ReferenceCitation: Balasubramanian CK, Neptune RR, Kautz SA. Variability in spatiotemporal step characteristics and its relationship to walking performance post-stroke. Gait Posture. 2009 Apr;29(3):408-14. doi: 10.1016/j.gaitpost.2008.10.061. Epub 2008 Dec 3.

ReferenceCitation: Gouelle A, Megrot F, Presedo A, Pennecot GF, Yelnik A. Validity of Functional Ambulation Performance Score for the evaluation of spatiotemporal parameters of children's gait. J Mot Behav. 2011;43(2):95-100. doi: 10.1080/00222895.2010.538768.


title: Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study

acronym: ITEP

summary: The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. Nevertheless, current consensual morphological and biological examinations are not very contributory, of difficult interpretation and expensive. The metabolic imagery in tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows detecting more often recurrences accessible to a curative surgery. We make the hypothesis that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC allows to decrease non curative recurrences appearance during the 3 years follow-up after a curative surgery.

ReferenceCitation: Sobhani I, Itti E, Luciani A, Baumgaertner I, Layese R, André T, Ducreux M, Gornet JM, Goujon G, Aparicio T, Taieb J, Bachet JB, Hemery F, Retbi A, Mons M, Flicoteaux R, Rhein B, Baron S, Cherrak I, Rufat P, Le Corvoisier P, de'Angelis N, Natella PA, Maoulida H, Tournigand C, Durand Zaleski I, Bastuji-Garin S. Colorectal cancer (CRC) monitoring by 6-monthly 18FDG-PET/CT: an open-label multicentre randomised trial. Ann Oncol. 2018 Apr 1;29(4):931-937. doi: 10.1093/annonc/mdy031.


title: Phase II, Multicentric Randomized Trial, Evaluating the Efficacy of Fluoropyrimidine-based Standard Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab

lead_sponsor: UNICANCER

source: euctr

ReferenceCitation: Bennouna J, Hiret S, Bertaut A, Bouché O, Deplanque G, Borel C, François E, Conroy T, Ghiringhelli F, des Guetz G, Seitz JF, Artru P, Hebbar M, Stanbury T, Denis MG, Adenis A, Borg C. Continuation of Bevacizumab vs Cetuximab Plus Chemotherapy After First Progression in KRAS Wild-Type Metastatic Colorectal Cancer: The UNICANCER PRODIGE18 Randomized Clinical Trial. JAMA Oncol. 2019 Jan 1;5(1):83-90. doi: 10.1001/jamaoncol.2018.4465.

summary:
The main objective is to evaluate progression-free survival (PFS) at 4 months.

The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria.

The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.


title: In-hospital Assessment of the New Medical Device AL539 Developed for the Home Monitoring of Continuous Positive Airway Pressure (CPAP) Treatment in Patients With Obstructive Sleep Apnea Syndrome by Comparison With Respiratory Polygraphy

summary:
Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS).

The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.

primary_purpose: Health Services Research

ReferenceCitation: Leger D, Elbaz M, Piednoir B, Carron A, Texereau J. Evaluation of the add-on NOWAPI® medical device for remote monitoring of compliance to Continuous Positive Airway Pressure and treatment efficacy in obstructive sleep apnea. Biomed Eng Online. 2016 Feb 27;15:26. doi: 10.1186/s12938-016-0139-4.

lead_sponsor: Air Liquide Santé International

location_facility: Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance


title: Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between bi-, Three-dimensional and Cardiac Magnetic Resonance

summary: compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

acronym: ABT737 exvivo

summary: The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.

lead_sponsor: Centre Francois Baclesse


title: A Phase I, Pharmacokinetic and Tolerability Study of Intravenous Unfractionated Heparin After Subcutaneous Enoxaparin 1mg/kg Bid Repeated Administration in Healthy Subjects

summary:
Primary objective:

to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects.

Secondary objective(s):

to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH
to assess the tolerability of the different anticoagulation protocols

ReferenceCitation: Drouet L, Bal dit Sollier C, Martin J. Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study. Am Heart J. 2009 Aug;158(2):177-84. doi: 10.1016/j.ahj.2009.05.022.


title: Randomized and Double-blind Clinical Trial of N-acetylcysteine Versus Placebo Efficacy in the Cannabis Withdrawal

acronym: MUCOCRAV

summary: The primary purpose is to assess the efficacy in human of N-acetylcysteine versus placebo during 4 weeks in cannabis withdrawal.

location_facility: Service de Psychiatrie - Hôpital Lariboisière


title: Cellular and Molecular Mechanisms Governing Bone Marrow Stem Cells, Macrophages and Plasma Cell Biology in Gaucher Disease.

acronym: MGMC

summary: Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside particularly in cells of the macrophage lineage. Clinical manifestations associate hematological, neurological and bone disorders.


title: NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.

acronym: NOMAC

summary: The consumption of cereals-based foods with low glycemic indexes, high micronutrients and fibers contents are highly recommended. The target of this work is to provide new solutions for cereal based foods: the knowledge and understanding on the in vivo fate will be used to define structural features to gain in foods.

lead_sponsor: Rennes University Hospital


title: A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.

summary: Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.


title: Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence

acronym: AVSAS

summary:
Stroke is the third leading cause of death in industrialized countries and the first cause of handicap in adults. Several stroke risk factors were identified such as high blood pressure, diabetes mellitus, hypercholesterolemia or cardiac arrhythmias. Sleep respiratory disorders have been found to be frequent among patients with stroke. Among them obstructive sleep apnea (OSA) syndrome seems to be the most important due to its association with high blood pressure and atrial fibrillation.

Stroke can be responsible of central apneas, therefore the differential diagnosis between central apneas and pure OSA after stroke is sometimes difficult. The misidentification of OSA can explain the poor tolerance of CPAP treatment by these patients. The purpose of the present study is to investigate the association between pre-stroke OSA syndrome OSA diagnosed on specific scales and confirmed by polygraphic studies and stroke occurrence.

lead_sponsor: University Hospital, Bordeaux

location_facility: Groupe Hospitalier Pellegrin - Place Amélie Raba Léon


title: Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study

summary: Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking. The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients.

ReferenceCitation: Jabaudon M, Chabanne R, Sossou A, Bertrand PM, Kauffmann S, Chartier C, Guérin R, Imhoff E, Zanre L, Brénas F, Bazin JE, Constantin JM. Epidural analgesia in the intensive care unit: An observational series of 121 patients. Anaesth Crit Care Pain Med. 2015 Aug;34(4):217-23. doi: 10.1016/j.accpm.2014.12.002. Epub 2015 May 23.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Parallel Randomised Open Phase II Study of Oxaliplatin (L-OHP) Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Locally Advanced or Metastatic Endometrial Cancer Previously Treated With Cisplatin or Arboplatin

summary: To determine the efficacy (response rate [RR], time to progression and survival) of oxaliplatin as a single agent and oxaliplatin in combination with 5 FU in patients with advanced/metastatic endometrial cancer pretreated with one prior chemotherapy regimen containing cisplatin (CDDP) or carboplatin and to define the safety profile of each arm of the above mentioned regimens in these patients


title: Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia

acronym: FPRMCI

summary:
Background: Dementias (Alzheimer's disease and related syndromes), in their sporadic form, have multifactorial origin. Several risk factors (RF) are currently recognized like the cardiovascular RF, some genes of susceptibility, but the impact [1] of traumatic life events (TLE), considered as psychosocial RF (Persson & Skoog, 1996; Charles et al, 2006), [2] of anxiety and/or depression, [3] of the premorbid personality (Clément et al, 2003) with his coping strategies, and [4] of the lifestyle (which results from the personality), for the moment are still underestimated. Dementia disease can be clinically preceded by a mild cognitive impairment (MCI) (Petersen et al, 1996) which is however potentially reversible.

Purpose: Actually, there is no study concerning the rate of conversion from MCI to dementia according to the presence or not of TLE. The aim of this study is to assess association between TLE and conversion rate from MCI to dementia.

Methods: Patients with MCI will be recruited in different memory clinics (Limoges and others) Primary outcome: Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE.

Secondary outcomes: Occurrence of dementia in MCI patients according to various other psychopathological factors: anxiety, depression, apathy, personality features, alexithymia and resilience levels and life style.

Study design: Epidemiologic cohort longitudinal and prospective multicenter study.

lead_sponsor: Centre Hospitalier Esquirol


title: Phase II Study of Oxaliplatin in Combination With 5-Fluorouracil (5-FU) in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)

design_allocation: Non-Randomized


title: "Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"

acronym: SL-PLUS

summary:
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).

We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.

Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.

lead_sponsor: Smith & Nephew Orthopaedics AG

location_facility: Hopital Salengro, Service d'Orthopédie C

intervention_type: Procedure


title: Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer

acronym: MOMAD

summary:
The global aim of our study is to validate eye movement recording as an early differential diagnostic tool, in order to discriminate as early as possible between neurodegenerative dementias of Alzheimer type and depressive pseudodementias (DPD). The investigators want to put forward idiosyncratic oculomotor characteristics of Alzheimer's disease (AD) and DPD respectively. Eye movements are sensitive markers of neurological diseases and can be used in a variety of clinical neurological syndromes.

This study compares 3 groups of 98 patients: patients suffering of AD and DPD and healthy persons. The patients AD will be recruited in the Memory Centre of Resources and Research of Besançon and patients DPD will be selected in the psychiatric department of the University Hospital of Besançon. The control participants will be recruited from the entourage of researchers and patients. The selection of participants in the 3 different groups is based on clinical examinations in psychiatry and neurology and neuropsychological assessments. After giving informed consent, patients will be evaluated by a psychiatrist and a neuropsychologist. The complete assessment takes 150 minutes.

After having set up patients, eye movements will be recorded using video-oculography techniques. The following tasks are performed: the basic dynamic eye movements (latency, hypometric and hypermetric saccades, reaction time, saccade speed, accuracy, pupil diameter) will be evaluated by the pro-saccade, anti-saccade and predictive saccade tasks. The emotional connotation tasks will be assessed by scan of images pair with emotional connotation and portrait analysis. The assessment takes 30 minutes.

This study will include 3 groups:

an Alzheimer group;
a depressed group;
a control group with healthy persons. The population of this study will be comprised of patients over age 60 with a visual acuity over 9/10, not diagnosed with eye disease and not neuropsychological sequelae that could disrupt the functioning oculomotor.

These people will be recruited on a voluntary basis, after notification and consent in the research center, the Psychiatry Clinical Department of the University Hospital of Besançon. This study was conducted over a period of 36 months.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Univserity Hospital of Besançon - Psychiatry Department


acronym: GRAAL

title: Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings

lead_sponsor: ALK-Abelló A/S

ReferenceCitation: Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX®) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig. 2012 Jul 1;32(7):451-63. doi: 10.2165/11634270-000000000-00000.

summary: The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.


title: Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies

acronym: DARWIM

summary: Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The main aim of this interventional study is to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.


title: Prospective Double Blind Multicentre Randomized Trial of Vitamine D Estimating the Profit of a Treatment by Vitamin D3 at the Dose of 100000 UI by Comparison With a Treatment in the Dose of 12 000 UI at Renal Transplanted Patients

acronym: VITALE

summary: It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this population is at risk of the previously cited complications.The primary purpose of this study is to compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and patient death.Renal transplant recipients between 12 and 48 months after transplantation will be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up of 2 years.

ReferenceCitation: Courbebaisse M, Alberti C, Colas S, Prié D, Souberbielle JC, Treluyer JM, Thervet E. VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial. Trials. 2014 Nov 6;15:430. doi: 10.1186/1745-6215-15-430.


title: Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).

acronym: DIAPASON

summary: The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.

ReferenceCitation: Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60.

ReferenceCitation: Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. Review.

ReferenceCitation: Bourgeois MS, Schulz R, Burgio L. Interventions for caregivers of patients with Alzheimer's disease: a review and analysis of content, process, and outcomes. Int J Aging Hum Dev. 1996;43(1):35-92. Review.

ReferenceCitation: Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64.

ReferenceCitation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96.

ReferenceCitation: Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14.

ReferenceCitation: Eisdorfer C, Czaja SJ, Loewenstein DA, Rubert MP, Argüelles S, Mitrani VB, Szapocznik J. The effect of a family therapy and technology-based intervention on caregiver depression. Gerontologist. 2003 Aug;43(4):521-31.

ReferenceCitation: Gallagher-Thompson D, Coon DW. Evidence-based psychological treatments for distress in family caregivers of older adults. Psychol Aging. 2007 Mar;22(1):37-51. Review.

ReferenceCitation: Gottlieb BH, Wolfe J. Coping with family caregiving to persons with dementia: a critical review. Aging Ment Health. 2002 Nov;6(4):325-42. Review.

ReferenceCitation: Livingston G, Manela M, Katona C. Depression and other psychiatric morbidity in carers of elderly people living at home. BMJ. 1996 Jan 20;312(7024):153-6.

ReferenceCitation: Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14.

ReferenceCitation: McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44.

ReferenceCitation: Mahoney DF, Tarlow BJ, Jones RN. Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. Gerontologist. 2003 Aug;43(4):556-67.

ReferenceCitation: Magnusson L, Hanson E, Brito L, Berthold H, Chambers M, Daly T. Supporting family carers through the use of information and communication technology--the EU project ACTION. Int J Nurs Stud. 2002 May;39(4):369-81. Review.

ReferenceCitation: Mittelman MS, Roth DL, Haley WE, Zarit SH. Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. J Gerontol B Psychol Sci Soc Sci. 2004 Jan;59(1):P27-34.

ReferenceCitation: Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, Mountain G, O'Connell M, Harrison J, Vasse E, Dröes RM, Orrell M; INTERDEM group. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health. 2008 Jan;12(1):14-29. doi: 10.1080/13607860801919850.

ReferenceCitation: Ramaroson H, Helmer C, Barberger-Gateau P, Letenneur L, Dartigues JF; PAQUID. [Prevalence of dementia and Alzheimer's disease among subjects aged 75 years or over: updated results of the PAQUID cohort]. Rev Neurol (Paris). 2003 Apr;159(4):405-11. French.

ReferenceCitation: Schulz R, O'Brien AT, Bookwala J, Fleissner K. Psychiatric and physical morbidity effects of dementia caregiving: prevalence, correlates, and causes. Gerontologist. 1995 Dec;35(6):771-91. Review.

ReferenceCitation: Schulz R, Beach SR. Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. JAMA. 1999 Dec 15;282(23):2215-9.

ReferenceCitation: Schulz R, Martire LM, Klinger JN. Evidence-based caregiver interventions in geriatric psychiatry. Psychiatr Clin North Am. 2005 Dec;28(4):1007-38, x. Review.

ReferenceCitation: Sörensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. Review.

ReferenceCitation: Teri L. Behavior and caregiver burden: behavioral problems in patients with Alzheimer disease and its association with caregiver distress. Alzheimer Dis Assoc Disord. 1997;11 Suppl 4:S35-8. Review.

ReferenceCitation: Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. Review.

ReferenceCitation: Yesavage JA. Geriatric depression scale: consistency of depressive symptoms over time. Percept Mot Skills. 1991 Dec;73(3 Pt 1):1032.

ReferenceCitation: Zarit SH, Todd PA, Zarit JM. Subjective burden of husbands and wives as caregivers: a longitudinal study. Gerontologist. 1986 Jun;26(3):260-6.

ReferenceCitation: González-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozúa B, Solà I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1:CD006440. doi: 10.1002/14651858.CD006440.pub3.

ReferenceCitation: Cristancho-Lacroix V, Wrobel J, Cantegreil-Kallen I, Dub T, Rouquette A, Rigaud AS. A web-based psychoeducational program for informal caregivers of patients with Alzheimer's disease: a pilot randomized controlled trial. J Med Internet Res. 2015 May 12;17(5):e117. doi: 10.2196/jmir.3717.

ReferenceCitation: Cristancho-Lacroix V, Kerhervé H, de Rotrou J, Rouquette A, Legouverneur G, Rigaud AS. Evaluating the efficacy of a web-based program (diapason) for informal caregivers of patients with Alzheimer's disease: protocol for a randomized clinical trial. JMIR Res Protoc. 2013 Dec 6;2(2):e55. doi: 10.2196/resprot.2978.

location_facility: Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic


title: Impact of Anti-TNF Antibodies on the T-lymphocyte and Macrophage Cooperation in the Crohn Disease

summary: The aim of this research is to study Crohn disease patients before and after anti-TNF, the cooperation between lamina propria T-lymphocytes and macrophages, through the expression of co-signalisation molecules and their ligands, the production of cytokines participating in this cooperation, and the potential role of regulatory T lymphocytes.

ReferenceCitation: Puntis J, McNeish AS, Allan RN. Long term prognosis of Crohn's disease with onset in childhood and adolescence. Gut. 1984 Apr;25(4):329-36.

ReferenceCitation: Rubin GP, Hungin AP, Kelly PJ, Ling J. Inflammatory bowel disease: epidemiology and management in an English general practice population. Aliment Pharmacol Ther. 2000 Dec;14(12):1553-9.

ReferenceCitation: Arnott ID, Watts D, Satsangi J. Azathioprine and anti-TNF alpha therapies in Crohn's disease: a review of pharmacology, clinical efficacy and safety. Pharmacol Res. 2003 Jan;47(1):1-10. Review.

ReferenceCitation: ten Hove T, van Montfrans C, Peppelenbosch MP, van Deventer SJ. Infliximab treatment induces apoptosis of lamina propria T lymphocytes in Crohn's disease. Gut. 2002 Feb;50(2):206-11.

ReferenceCitation: MacDonald TT, Di Sabatino A, Gordon JN. Immunopathogenesis of Crohn's disease. JPEN J Parenter Enteral Nutr. 2005 Jul-Aug;29(4 Suppl):S118-24; discussion S124-5, S184-8. Review. Erratum in: JPEN J Parenter Enteral Nutr. 2006 Jan-Feb;30(1):table of contents. DiSabatino, Antonio [corrected to Di Sabatino, Antonio].

ReferenceCitation: Powrie F, Leach MW, Mauze S, Menon S, Caddle LB, Coffman RL. Inhibition of Th1 responses prevents inflammatory bowel disease in scid mice reconstituted with CD45RBhi CD4+ T cells. Immunity. 1994 Oct;1(7):553-62.

ReferenceCitation: Noguchi M, Hiwatashi N, Liu Z, Toyota T. Secretion imbalance between tumour necrosis factor and its inhibitor in inflammatory bowel disease. Gut. 1998 Aug;43(2):203-9.

ReferenceCitation: Itoh J, de La Motte C, Strong SA, Levine AD, Fiocchi C. Decreased Bax expression by mucosal T cells favours resistance to apoptosis in Crohn's disease. Gut. 2001 Jul;49(1):35-41.

ReferenceCitation: Baert FJ, D'Haens GR, Peeters M, Hiele MI, Schaible TF, Shealy D, Geboes K, Rutgeerts PJ. Tumor necrosis factor alpha antibody (infliximab) therapy profoundly down-regulates the inflammation in Crohn's ileocolitis. Gastroenterology. 1999 Jan;116(1):22-8.

ReferenceCitation: Filippi J, Mambrini P, Arab K, Schneider SM, Hébuterne X. [Treatment of oesophageal Crohn's disease by infliximab]. Gastroenterol Clin Biol. 2005 Jan;29(1):84-5. French.

ReferenceCitation: Mitoma H, Horiuchi T, Hatta N, Tsukamoto H, Harashima S, Kikuchi Y, Otsuka J, Okamura S, Fujita S, Harada M. Infliximab induces potent anti-inflammatory responses by outside-to-inside signals through transmembrane TNF-alpha. Gastroenterology. 2005 Feb;128(2):376-92.

ReferenceCitation: Agnholt J, Kaltoft K. Infliximab downregulates interferon-gamma production in activated gut T-lymphocytes from patients with Crohn's disease. Cytokine. 2001 Aug 21;15(4):212-22.

ReferenceCitation: Lügering A, Schmidt M, Lügering N, Pauels HG, Domschke W, Kucharzik T. Infliximab induces apoptosis in monocytes from patients with chronic active Crohn's disease by using a caspase-dependent pathway. Gastroenterology. 2001 Nov;121(5):1145-57.

ReferenceCitation: Danese S, Sans M, Scaldaferri F, Sgambato A, Rutella S, Cittadini A, Piqué JM, Panes J, Katz JA, Gasbarrini A, Fiocchi C. TNF-alpha blockade down-regulates the CD40/CD40L pathway in the mucosal microcirculation: a novel anti-inflammatory mechanism of infliximab in Crohn's disease. J Immunol. 2006 Feb 15;176(4):2617-24.

ReferenceCitation: Filippi J, Roger PM, Schneider SM, Durant J, Breittmayer JP, Benzaken S, Bernard A, Dellamonica P, Hébuterne X; Groupe d'Etude Niçois Polyvalent en Infectiologie (GENPI). Infliximab and human immunodeficiency virus infection: Viral load reduction and CD4+ T-cell loss related to apoptosis. Arch Intern Med. 2006 Sep 18;166(16):1783-4.

ReferenceCitation: Makita S, Kanai T, Oshima S, Uraushihara K, Totsuka T, Sawada T, Nakamura T, Koganei K, Fukushima T, Watanabe M. CD4+CD25bright T cells in human intestinal lamina propria as regulatory cells. J Immunol. 2004 Sep 1;173(5):3119-30.

ReferenceCitation: Kelsen J, Agnholt J, Hoffmann HJ, Rømer JL, Hvas CL, Dahlerup JF. FoxP3(+)CD4(+)CD25(+) T cells with regulatory properties can be cultured from colonic mucosa of patients with Crohn's disease. Clin Exp Immunol. 2005 Sep;141(3):549-57.

ReferenceCitation: Ochsenkühn T, Göke B, Sackmann M. Combining infliximab with 6-mercaptopurine/azathioprine for fistula therapy in Crohn's disease. Am J Gastroenterol. 2002 Aug;97(8):2022-5.

ReferenceCitation: Rutgeerts P, Van Assche G, Vermeire S. Optimizing anti-TNF treatment in inflammatory bowel disease. Gastroenterology. 2004 May;126(6):1593-610. Review.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Fédération des Maladies de l'appareil Digestif et de la Nutrition


title: Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.

summary: The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).

lead_sponsor: Nantes University Hospital


title: Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination

summary: The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).

status: Withdrawn

lead_sponsor: Boehringer Ingelheim

location_facility: 1249.7.33003 Boehringer Ingelheim Investigational Site


title: Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma

summary:
RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.

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

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

intervention_type: Genetic


title: Effects of a Single Dose of Intrathecal Magnesium Sulfate on Postoperative Morphine Consumption After Total Hip Replacement

summary: Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system [1]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.

ReferenceCitation: Mayer ML, Westbrook GL. Permeation and block of N-methyl-D-aspartic acid receptor channels by divalent cations in mouse cultured central neurones. J Physiol. 1987 Dec;394:501-27.

ReferenceCitation: Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents.


title: Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer

summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works in treating patients with advanced or metastatic colorectal cancer.

ReferenceType: result

ReferenceCitation: Rouits E, Charasson V, Pétain A, Boisdron-Celle M, Delord JP, Fonck M, Laurand A, Poirier AL, Morel A, Chatelut E, Robert J, Gamelin E. Pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of irinotecan in metastatic colorectal cancer patients. Br J Cancer. 2008 Oct 21;99(8):1239-45. doi: 10.1038/sj.bjc.6604673. Epub 2008 Sep 16.

ReferenceCitation: Rollin J, Payancé A, Gouilleux-Gruart V, Boisdron-Celle M, Azzopardi N, Morel A, Gruel Y, Paintaud G, Gamelin E, Watier H, Lecomte T. Significant effect of VEGFA polymorphisms on the clinical outcome of metastatic colorectal cancer patients treated with FOLFIRI-cetuximab. Pharmacogenomics. 2015 Dec;16(18):2035-43. doi: 10.2217/pgs.15.139. Epub 2015 Nov 30.

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Biological


title: Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer

summary:
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.

ReferenceCitation: Deyme L, Barbolosi D, Mbatchi LC, Tubiana-Mathieu N, Ychou M, Evrard A, Gattacceca F. Population pharmacokinetic model of irinotecan and its four main metabolites in patients treated with FOLFIRI or FOLFIRINOX regimen. Cancer Chemother Pharmacol. 2021 Aug;88(2):247-258. doi: 10.1007/s00280-021-04255-9. Epub 2021 Apr 28.

lead_sponsor: Centre Hospital Regional Universitaire de Limoges


title: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

summary:
Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode.

The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.

ReferenceCitation: Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.


title: Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort

acronym: EPIPAGEADO

summary: EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

ReferenceCitation: Hadchouel A, Rousseau J, Rozé JC, Arnaud C, Bellino A, Couderc L, Marret S, Mittaine M, Pinquier D, Verstraete M, Ancel PY, Delacourt C; EPIPAGEADO study group. Association between asthma and lung function in adolescents born very preterm: results of the EPIPAGE cohort study. Thorax. 2018 Dec;73(12):1174-1176. doi: 10.1136/thoraxjnl-2017-211115. Epub 2018 Mar 31.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma

acronym: REVALLO

summary: Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.


title: Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor

summary:
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.

PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial

acronym: HFPV

summary: During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies

ReferenceCitation: Dumas De La Roque E, Bertrand C, Tandonnet O, Rebola M, Roquand E, Renesme L, Elleau C. Nasal high frequency percussive ventilation versus nasal continuous positive airway pressure in transient tachypnea of the newborn: a pilot randomized controlled trial (NCT00556738). Pediatr Pulmonol. 2011 Mar;46(3):218-23. doi: 10.1002/ppul.21354. Epub 2010 Oct 20.

location_facility: Néonatalogie - Maternité - Hôpital Pellegrin


title: Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder

acronym: GEMCIRAV

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with cisplatin and radiation therapy and to see how well they work in treating patients with stage II or stage III bladder cancer.

intervention_type: Radiation


title: Phase II Study Evaluating the Efficacy and Safety of cétuximab Associated With the Protocol FOLFIRINOX (LV5FU Simplified Combined With Irinotecan and Oxaliplatin) in the First Line Treatment in Patients With Metastatic Colorectal Cancer Expressing EGFR or Not

summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer.


title: Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema

acronym: CPAP

summary: The investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.

ReferenceCitation: Ducros L, Logeart D, Vicaut E, Henry P, Plaisance P, Collet JP, Broche C, Gueye P, Vergne M, Goetgheber D, Pennec PY, Belpomme V, Tartière JM, Lagarde S, Placente M, Fievet ML, Montalescot G, Payen D; CPAP collaborative study group. CPAP for acute cardiogenic pulmonary oedema from out-of-hospital to cardiac intensive care unit: a randomised multicentre study. Intensive Care Med. 2011 Sep;37(9):1501-9. doi: 10.1007/s00134-011-2311-4. Epub 2011 Jul 30.


title: Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack

acronym: STEPSTIM

summary:
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.

The aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.


title: Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

summary:
The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13).

The objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.

lead_sponsor: Centre Oscar Lambret


title: Abdominal Aortic Aneurysms Are Associated With Pseudoexfoliation Syndrome

summary: Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.

lead_sponsor: European Georges Pompidou Hospital


title: EVALUATION DU RISQUE RESIDUEL DE TRANSMISSION DU VIH CHEZ DES HSH TRAITES AYANT UNE CHARGE VIRALE PLASMATIQUE INDETECTABLE

acronym: EP 49 EVARIST

summary:
The main objective of this one year multidisciplinary research is to estimate the frequency of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an undetectable blood viral load (VL) and a detectable VL in semen.

Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments participating to the research project. To warrant feasibility and diversity of participants needed, the centers will be located in Paris and nearby suburbs. The study design is based on one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be taken in the enrolment centers. Biological and virological analyses will be performed by the laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological analyses are planned in a subsequent study. Socio-behavioral data will be collected through a self-administered questionnaire at day 0 and day 30.

Schedule: Patients' enrolment, collection of biological samples and questionnaires will last 10 months (end of first quarter 2012). Biological and virological analyses will be performed until the end of the first semester 2012. Quantitative and socio-behavioral data will be analyzed during the third quarter 2012. Results will be released at the beginning of year 2013.

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


title: Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.

ReferenceCitation: Jary M, Lecomte T, Bouché O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Léger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

lead_sponsor: Hopital Jean Minjoz

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: PET Study of the Nicotinic Receptors in Human : Brain Distribution and Quantification

summary: The purpose of this study is to quantify the brain distribution of the nicotinic receptors in human volunteers and their alterations in patients suffering from neurological diseases such as Parkinson and Alzheimer diseases and familial epilepsy. This will be done using Postron Emission Tomography (PET) and a new radiotracer of the nicotinic receptors.

lead_sponsor: Commissariat A L'energie Atomique

location_facility: CEA, Service Hospitalier Frederic Joliot


title: Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area (SII) and Insula : an fMRI Study

summary:
The implication of the second somatosensory area (SII) and the insular cortex in the processing of somatosensory inputs is now well established. However the functional anatomy of these areas hidden in the depth of the sylvian scissure remain mostly unknown.

The aim of this fMRI study is to determine the functional cartography of SII and insula. The localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.

ReferenceCitation: Mazzola L, Isnard J, Mauguière F. Somatosensory and pain responses to stimulation of the second somatosensory area (SII) in humans. A comparison with SI and insular responses. Cereb Cortex. 2006 Jul;16(7):960-8. Epub 2005 Sep 21.

ReferenceCitation: Peyron R, Schneider F, Faillenot I, Convers P, Barral FG, Garcia-Larrea L, Laurent B. An fMRI study of cortical representation of mechanical allodynia in patients with neuropathic pain. Neurology. 2004 Nov 23;63(10):1838-46.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de Neurologie - CHU de Saint-Etienne


title: Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients (The ERIS Trial)

acronym: ERIS

summary:
Context:

Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men.

After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation. Moreover, PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse. In this context, biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue.

Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines and Citrate within the prostate gland.

Objectives:

The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate.

lead_sponsor: Centre Georges Francois Leclerc


title: Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study

acronym: HYGEM

summary: The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side effect and subsequent fertility.

location_facility: Service de Gynecologie-Obstetrique, Hopital Lariboisière


title: Descriptive Study Evaluating the Presence and Function of Natural Killer Cells in Elderly Patients With Acute Myeloid Leukemia in First Remission.

summary:
RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy.

PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


type: Registry Identifier

title: Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training

acronym: VENTILOBE

summary:
Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is associated with the development of weight-related comorbid conditions and increased morbidity.

Regular physical activity is an important modality of obesity management. Despite controversies, poor exercise tolerance has frequently been reported in youth obesity and the cause of this limited exercise tolerance remains unknown. Several factors accompanying obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary volumes are associated with obesity and may impact exercise intolerance in this population. Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to exercise can become constrained in obesity. A thorough understanding of the mechanisms underlying this exercise intolerance remains fundamental in order to favour long term adherence to exercise training. This is especially true in youth populations, in which the management of overweight and obesity must be undertaken as soon as possible, due to the early onset of cardiovascular risk factors.

The main purpose of this study is to determine early-onset cardio-respiratory mortality factors in obese adolescents as well as their relation with exercise intolerance (i.e. dyspnea) when compared with age and gender-paired normal-weight volunteers.

lead_sponsor: University Hospital, Grenoble


title: Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie

summary: To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma

lead_sponsor: French Innovative Leukemia Organisation


title: Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients

summary: Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to select the patients to whom the procedure would benefit the most.

status: Active, not recruiting

status_simplified: Ongoing


title: Lowering VT and Increasing PEP During One-Lung Ventilation (OLV), Impact on Oxygenation

acronym: REVOLU

summary: During general anesthesia, airway closure and the formation of atelectasis impair oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar recruitment when TV is reduced.

ReferenceCitation: Fernández-Pérez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8.

ReferenceCitation: Gothard J. Lung injury after thoracic surgery and one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):5-10. Review.

ReferenceCitation: Slinger P. Pro: low tidal volume is indicated during one-lung ventilation. Anesth Analg. 2006 Aug;103(2):268-70.

ReferenceCitation: Sentürk M. New concepts of the management of one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):1-4. Review.

ReferenceCitation: Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. Review.

ReferenceCitation: Michelet P, D'Journo XB, Roch A, Doddoli C, Marin V, Papazian L, Decamps I, Bregeon F, Thomas P, Auffray JP. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006 Nov;105(5):911-9.

lead_sponsor: University Hospital, Bordeaux

location_facility: Département d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux


title: Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation

summary: Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome

acronym: Proseva

summary: We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2<150 with FiO2 > or = 0.6 and positive end-expiratory pressure > or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.

ReferenceCitation: Guérin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384.

ReferenceCitation: Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

lead_sponsor: Hospices Civils de Lyon


title: The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias

acronym: BÉA/T

summary: The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.


title: Impact of External Cooling in Septic Shock Patients

acronym: sepsis-cool

summary: The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.

ReferenceCitation: Schortgen F, Charles-Nelson A, Bouadma L, Bizouard G, Brochard L, Katsahian S. Respective impact of lowering body temperature and heart rate on mortality in septic shock: mediation analysis of a randomized trial. Intensive Care Med. 2015 Oct;41(10):1800-8. doi: 10.1007/s00134-015-3987-7. Epub 2015 Jul 23.


title: Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.

summary: The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.

lead_sponsor: University Hospital, Rouen

location_facility: Rouen University Hospital, Direction de la Recherche et de l'Innovation,


title: A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer

summary: Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

lead_sponsor: ARCAGY/ GINECO GROUP


title: Evaluation of the Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain. A Randomized Controlled Trial Using a Modified ZELEN Method

acronym: REVLOC

summary: Chronic low back pain and sciatica in adults represent a major medical and economic problem. During the chronic back pain (persisting continuously over 3 months), therapeutic responses to conventional pharmacologic type are often ineffective and the impact of pain is often heavy in terms of disability, social and professional avulsion and loss of quality of life. This failure has led in recent years to propose innovative strategies such as application of relaxation therapy techniques. An example is a virtual reality which is a technology to immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion combined with virtual reality can be effective on chronic pain. The main purpose is to measure the impact on the intensity of pain at 4 months after using of a new method for virtual environment, mimicking the colors from low to high frequencies (World Patent Filed, WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to therapeutic drugs.


title: Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates

summary:
Objective: To study the feasibility and validity of a two-step telephone screening procedure for symptomatic knee and hip osteoarthritis (OA) in the general population.

Method: The screening questionnaire was based on signs and symptoms, previous diagnosis of OA, and validated OA criteria. A random sample of telephone numbers was obtained and, at each number, one individual aged 40 to 75 years was included. A physical examination and knee or hip radiographs were offered when the screen was positive. A sample of individuals with negative screens was also examined. The diagnosis of hip/knee OA was based on either American College of Rheumatology criteria for signs and symptoms and Kellgren-Lawrence radiographic stage 2 or greater. Prevalence rates were estimated with correction for the performance of the screening procedure.

time_perspective: Other

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Rheumatology department, Nice University hospital


title: A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer

summary: To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).

lead_sponsor: Sanofi


title: Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

summary: Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in suppressing adaptative immune responses, including B cells production of immunoglobulins. We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.

ReferenceCitation: Laville M, Alamartine E. Treatment options for IgA nephropathy in adults: a proposal for evidence-based strategy. Nephrol Dial Transplant. 2004 Aug;19(8):1947-51. Epub 2004 May 25.

ReferenceCitation: Mariat C, Sánchez-Fueyo A, Alexopoulos SP, Kenny J, Strom TB, Zheng XX. Regulation of T cell dependent immune responses by TIM family members. Philos Trans R Soc Lond B Biol Sci. 2005 Sep 29;360(1461):1681-5. Review.

ReferenceCitation: Mariat C Degauque N et al. TIM-1 strengthens Th-1 polarization and weakens CD4+CD25 T cells. Am J Transplant 6(suppl 2): 557, 2006

location_facility: Nephrology Unit Hôpital Nord CHU de Saint-Etienne


title: Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product

summary: This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.

lead_sponsor: Novo Nordisk A/S


title: A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire

summary: validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.


title: Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation

summary: The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment.

lead_sponsor: University Hospital, Montpellier


title: Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)

acronym: TRACE

summary: Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.


title: Mazindol in Children With Attention Deficit Hyperactivity Disorder Design Study to Explore the Effectiveness, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Orally Administered Doses of Mazindol.

acronym: MAZDAH

summary: This prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) properties of mazindol.

lead_sponsor: Assistance Publique - Hôpitaux de Paris