title: Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.

summary: The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis

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ReferenceCitation: Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87.

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ReferenceCitation: Hoeller U, Borgmann K, Bonacker M, Kuhlmey A, Bajrovic A, Jung H, Alberti W, Dikomey E. Individual radiosensitivity measured with lymphocytes may be used to predict the risk of fibrosis after radiotherapy for breast cancer. Radiother Oncol. 2003 Nov;69(2):137-44.

ReferenceCitation: Hsieh FY, Lavori PW. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Control Clin Trials. 2000 Dec;21(6):552-60.

ReferenceCitation: Iannuzzi CM, Atencio DP, Green S, Stock RG, Rosenstein BS. ATM mutations in female breast cancer patients predict for an increase in radiation-induced late effects. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):606-13.

ReferenceCitation: Jacob R, Hanlon AL, Horwitz EM, Movsas B, Uzzo RG, Pollack A. Role of prostate dose escalation in patients with greater than 15% risk of pelvic lymph node involvement. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):695-701.

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ReferenceCitation: Kiltie AE, Ryan AJ, Swindell R, Barber JB, West CM, Magee B, Hendry JH. A correlation between residual radiation-induced DNA double-strand breaks in cultured fibroblasts and late radiotherapy reactions in breast cancer patients. Radiother Oncol. 1999 Apr;51(1):55-65.

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ReferenceCitation: Azria D, Riou O, Castan F, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Bourgier C, Rivera S, Noël G, Clippe S, Mornex F, Hennequin C, Kramar A, Gourgou S, Pèlegrin A, Fenoglietto P, Ozsahin EM. Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial. EBioMedicine. 2015 Oct 25;2(12):1965-73. doi: 10.1016/j.ebiom.2015.10.024. eCollection 2015 Dec.


title: Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration

acronym: EPURE

summary: The TUNA is a known and already old technique. There exists, in the literature, a certain number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the flow mictional.This effectiveness is slightly lower than that of the endoscopic resection of prostate. This technique does not present the disadvantages of the surgery prostate sufferer on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it is the case in particular in the States Unis. The aim of the study which will be led by the AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less 24 hours.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: "Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography (PeaPod) and Multiple-frequency Bio-impedance Analysis (BIA)"

summary:
Low birth weight and prematurity are associated with adverse metabolic outcome in adult life. Yet it remains to be determined whether this outcome is the consequence of the low birth weight per se, or of the catch up growth achieved in Neonatology units using an early, 'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote fat mass, rather than lean body mass accretion. Assessment of body composition therefore is key to evaluate the efficacy of the nutritional management of these infants. Scarce data is, however, available in the literature about the body composition of healthy full-term neonates in the first few days of life.

The aim of this study is to:

Evaluate the feasibility and reproducibility of a safe and non invasive method of measurement of infant body composition by Air Displacement Plethysmography (PeaPod). Anthropometry and BIA will be used as the reference techniques to assess the accuracy of the PeaPod
Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life
Obtain data on the total body water content of healthy full term infants from BIA.

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Nantes University Hospital


type: Registry Identifier

title: Les Cartes Sensori-motrices De La Parole : Corrélats Neuroanatomiques Des Systèmes De Perception Et De Production Des Voyelles Du Français

acronym: SPIM

summary: Speech develops through a co-structuring of auditory and motor representations, especially in the first years of life during language acquisition. In the present study, we will test by means of functional magnetic resonance imaging whether vowel perception and production might depend on a coordination of auditory and motor, articulatory, cortical maps. The outcome of this study will lead to a better understanding of whether both vowel perception and production are processed in the human brain and will provide important insight into brain-language relationships. Besides new theoretical perspectives on speech perception and production, this project might raise important questions concerning patients with speech disorders by identifying which aspects of speech perception and production are functionally linked.

lead_sponsor: University Hospital, Grenoble

intervention_type: Device


title: Evaluation of Hepatic Mitochondrial Function in Sepsis

summary:
Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction has been shown in skeletal muscle of critically ill septic patients. Liver is very important in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover hepatic failure is associated to a bad outcome.

The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.

study_start_date_type: Anticipated

status: Withdrawn

ReferenceType: background

ReferenceCitation: Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23.

ReferenceCitation: Fredriksson K, Hammarqvist F, Strigård K, Hultenby K, Ljungqvist O, Wernerman J, Rooyackers O. Derangements in mitochondrial metabolism in intercostal and leg muscle of critically ill patients with sepsis-induced multiple organ failure. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1044-50. Epub 2006 Jun 27. Erratum in: Am J Physiol Endocrinol Metab. 2007 Apr;292(4):E1240.

lead_sponsor: Professor C ICHAI

lead_sponsor_type: industriel

status_simplified: Unknown


title: Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia

summary:
Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.

Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.

The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Effect of Deep Brain Stimulation of the Hypothalamus/ Fornix on Memory Impairment in Patients With Alzheimer's Disease

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

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

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

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire de Nice

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


title: Fatty Liver and Ectopic Fat in Overweight and Obese Patients

summary: The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

location_facility: Hepatogastroenterology, Hôpital l'Archet, CHU de Nice


title: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

acronym: HITUPPAC-BIO

summary: The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010. Review.


title: Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.

lead_sponsor: Centre Antoine Lacassagne

intervention_type: Drug


title: Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study

summary:
RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neurotoxicity.

PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Genetic


title: Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison

acronym: CATETEL

summary: There is actually two techniques of subclavian vein ultrasonography-guided venous catheterization : the axial and longitudinal approach. Currently, nothing makes it possible to privilege one technique compared to the other. This study aims to determine the best ultrasonography-guided method.

primary_purpose: Supportive Care

ReferenceCitation: Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. Review.

ReferenceCitation: Forestier F, Rossi H, Calderon J, Soubiron L, Bourdarias B, Janvier G. [Training for adult subclavian venous catheterization: use of real-time echography]. Ann Fr Anesth Reanim. 2002 Nov;21(9):698-702. French.

ReferenceCitation: Brooks AJ, Alfredson M, Pettigrew B, Morris DL. Ultrasound-guided insertion of subclavian venous access ports. Ann R Coll Surg Engl. 2005 Jan;87(1):25-7.

lead_sponsor: University Hospital, Bordeaux


title: XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent " Xience V® " Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

acronym: XERES

summary: Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.

lead_sponsor: Abbott Medical Devices


title: Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.

acronym: Laryngotest

summary: The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.

ReferenceCitation: Buléon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gérard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.

lead_sponsor: University Hospital, Caen


title: Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements

summary:
MR Elastography is a new technique aimed at non-invasively measuring the stiffness of tissues. It has recently given interesting results in the assessment of liver fibrosis.

The objectives of the current study are:

to develop an imaging protocol for MR Elastography of the kidneys;
To calculate the stiffness of normal kidneys;
To evaluate the variability of the measurements of kidney stiffness by repeating the procedure twice on the same volunteers.

ReferenceType: result

ReferenceCitation: Rouvière O, Souchon R, Pagnoux G, Ménager JM, Chapelon JY. Magnetic resonance elastography of the kidneys: feasibility and reproducibility in young healthy adults. J Magn Reson Imaging. 2011 Oct;34(4):880-6. doi: 10.1002/jmri.22670. Epub 2011 Jul 18.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Urinary an Vascular Radiology, Hôpital E. Herriot


intervention_type: Biological

acronym: AACER

title: Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

source: euctr

summary:
RATIONALE: Drugs used in chemotherapy, such as 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. 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. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.


title: Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure

summary: The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

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

location_facility: Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey


title: Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia

summary: The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

lead_sponsor: Hôpital le Vinatier


summary:
Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor D2 isoforms has been found in endocrine tumors.

Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.

ReferenceCitation: Saveanu A, Sebag F, Guillet B, Archange C, Essamet W, Barlier A, Palazzo FF, Taïeb D. Targeting dopamine receptors subtype 2 (D2DR) in pheochromocytomas: head-to-head comparison between in vitro and in vivo findings. J Clin Endocrinol Metab. 2013 Dec;98(12):E1951-5. doi: 10.1210/jc.2013-2269. Epub 2013 Sep 5.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hopitaux de Marseille

intervention_type: Other


title: Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, 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 whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.

PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.

ReferenceCitation: Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.

lead_sponsor: Institut Curie

intervention_type: Radiation


title: A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

summary: The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.

primary_purpose: Other

lead_sponsor: LEO Pharma


title: Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial.

acronym: ELVIS

summary: The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.

ReferenceCitation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Mégarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

ReferenceCitation: Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4:CD013554. doi: 10.1002/14651858.CD013554.pub2. Review.

ReferenceCitation: Boyer A, Timsit JF, Klouche K, Canet E, Phan TN, Bohé J, Rubin S, Orieux A, Lautrette A, Gruson D, Souweine B. Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study. Clin Ther. 2021 Jun;43(6):1116-1124. doi: 10.1016/j.clinthera.2021.04.011. Epub 2021 May 24.

ReferenceCitation: Souweine B, Lautrette A, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Guelon D, Darmon M, Vesin A, Caillot N, Schwebel C, Boyer A, Azoulay E, Bouadma L, Timsit JF. Ethanol lock and risk of hemodialysis catheter infection in critically ill patients. A randomized controlled trial. Am J Respir Crit Care Med. 2015 May 1;191(9):1024-32. doi: 10.1164/rccm.201408-1431OC.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy

acronym: PLATON

summary:
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.

PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

study_start_date_type: Actual

status: Terminated

ReferenceCitation: Beguin Y. Prediction of response to treatment with recombinant human erythropoietin in anaemia associated with cancer. Med Oncol. 1998 Aug;15 Suppl 1:S38-46. Review.

ReferenceCitation: Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur J Cancer. 2004 Oct;40(15):2201-16. Review.

ReferenceCitation: Bonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res. 1996 Jun;5(3):309-20.

ReferenceCitation: Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol. 1997 Jul;34(3 Suppl 2):13-9.

ReferenceCitation: Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60.

ReferenceCitation: Del Mastro L, Gennari A, Donati S. Chemotherapy of non-small-cell lung cancer: role of erythropoietin in the management of anemia. Ann Oncol. 1999;10 Suppl 5:S91-4. Review.

ReferenceCitation: Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998 Oct;16(10):3412-25.

ReferenceCitation: Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol. 1997 Mar;15(3):1218-34.

ReferenceCitation: Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst. 1999 Oct 6;91(19):1616-34. Review. Erratum in: J Natl Cancer Inst 2000 Mar 15;92(6):497.

ReferenceCitation: Littlewood TJ. The impact of hemoglobin levels on treatment outcomes in patients with cancer. Semin Oncol. 2001 Apr;28(2 Suppl 8):49-53. Review.

ReferenceCitation: Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P; European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007 Jan;43(2):258-70. Epub 2006 Dec 19. Review.

ReferenceCitation: Aapro M, Coiffier B, Dunst J, Osterborg A, Burger HU. Effect of treatment with epoetin beta on short-term tumour progression and survival in anaemic patients with cancer: A meta-analysis. Br J Cancer. 2006 Dec 4;95(11):1467-73. Epub 2006 Nov 21.

ReferenceCitation: Oberhoff C. Speed of haemoglobin response in patients with cancer: a review of the erythropoietic proteins. Support Care Cancer. 2007 Jun;15(6):603-611. doi: 10.1007/s00520-006-0191-x. Epub 2007 Feb 3. Review.

ReferenceCitation: Pujade-Lauraine E, Topham C. Once-weekly treatment of anemia in patients with cancer: a comparative review of epoetins. Oncology. 2005;68(2-3):122-9. Epub 2005 Jul 7. Review.

ReferenceCitation: Veys N, Dhondt A, Lameire N. Pain at the injection site of subcutaneously administered erythropoietin: phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol. 1998 Jan;49(1):41-4.

ReferenceCitation: Thomas ML. Impact of anemia and fatigue on quality of life in cancer patients: a brief review. Med Oncol. 1998 Aug;15 Suppl 1:S3-7. Review.

ReferenceCitation: Vogelzang NJ, Breitbart W, Cella D, Curt GA, Groopman JE, Horning SJ, Itri LM, Johnson DH, Scherr SL, Portenoy RK. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol. 1997 Jul;34(3 Suppl 2):4-12.

ReferenceCitation: Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74.

ReferenceCitation: Harrell FE Jr, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996 Feb 28;15(4):361-87. Review.

ipd_sharing: No

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

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


title: Study of Ocular Blood Flow Using Laser Doppler Flowmetry in Patients With Glaucoma and/or OSAS

summary:
Obstructive sleep apnea syndrome (OSAS) is a common disease, with a prevalence evaluated between 5 - 7% in the general population. OSAS is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, which are nearly systematically associated with a desaturation-reoxygenation sequence, an admitted detrimental stimulus for the cardiovascular system. It has now been demonstrated that OSAS per se is able to generate hypertension, atherosclerosis and autonomic dysfunction (high sympathic tone and increase in baseline heart rate), all conditions possibly interacting with ocular vascular regulation. OSAS has major consequences on the ocular level since it is associated with a higher frequency of optic neuropathies, such as glaucoma and nonarteritic ischemic optic neuropathy (NAION), both with functional severe prognosis. Most of vascular changes associated with OSAS have been studied at the level of macrovasculature. In terms of physiopathology, the main effects on the vascular system in OSAS are sympathetic hyperactivity, oxidative stress, development of endothelial dysfunction, systemic inflammation and metabolic alterations such as the appearance of insulin resistance. All these mechanisms can affect the microcirculation of the eye, especially the optic nerve and choroid. Our hypothesis is that the eye microvasculature is affected by OSAS, and these lesions may be detected via a reduced autoregulation of blood flow in humans.

This project aims to demonstrate, quantify, and analyze the vascular modifications of the eye associated with OSAS trough a comparative clinical study on glaucoma patients and OSAS patients and matched healthy subjects for the regulation of the eye blood flow using confocal laser Doppler flowmetry (LDF). The regulation of the ocular blood flow will be assessed using several stimuli and measured using a new confocal LDF.

primary_purpose: Basic Science

ReferenceCitation: Chiquet C, Lacharme T, Riva C, Almanjoumi A, Aptel F, Khayi H, Arnol N, Romanet JP, Geiser M. Continuous response of optic nerve head blood flow to increase of arterial blood pressure in humans. Invest Ophthalmol Vis Sci. 2014 Jan 23;55(1):485-91. doi: 10.1167/iovs.13-12975.

ReferenceCitation: Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.

lead_sponsor: University Hospital, Grenoble


title: Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery

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

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

ReferenceCitation: Penel N, Ray-Coquard I, Bal-Mahieu C, Chevreau C, Le Cesne A, Italiano A, Bompas E, Clisant S, Baldeyrou B, Lansiaux A, Robin YM, Bay JO, Piperno-Neumann S, Blay JY, Fournier C. Low level of baseline circulating VEGF-A is associated with better outcome in patients with vascular sarcomas receiving sorafenib: an ancillary study from a phase II trial. Target Oncol. 2014 Sep;9(3):273-7. doi: 10.1007/s11523-013-0299-0. Epub 2013 Nov 12.

ReferenceCitation: Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.

ReferenceCitation: Ray-Coquard I, Italiano A, Bompas E, Le Cesne A, Robin YM, Chevreau C, Bay JO, Bousquet G, Piperno-Neumann S, Isambert N, Lemaitre L, Fournier C, Gauthier E, Collard O, Cupissol D, Clisant S, Blay JY, Penel N; French Sarcoma Group (GSF/GETO). Sorafenib for patients with advanced angiosarcoma: a phase II Trial from the French Sarcoma Group (GSF/GETO). Oncologist. 2012;17(2):260-6. doi: 10.1634/theoncologist.2011-0237. Epub 2012 Jan 27.

lead_sponsor: Centre Oscar Lambret


title: Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy

acronym: Lactaide

summary: Sublingual immunotherapy is developing in the treatment of aeroallergens allergy. The hypothesis is that such process may be applied to food allergy, more precisely to milk. A previous series of 8 patients indicates the likely effectiveness of this technique (Allergy, 2006).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

summary:
RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.

PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.


title: New Analgesic Strategy Combining Nitrous Oxide, Nefopam, Acetaminophen and Morphine Compared to the Usal Antalgic Strategy (Acetaminophen and Morphine) for the Treatment of Acute Sickle Cell Disease Pain in the Emergency Room

acronym: DREPANOX

summary:
Quality of life of adult patients with sickle cell disease is deeply impaired by severe adverse medical events that inadvertently occur throughout their time life. Indeed, patients not presenting a life threatening condition often present to the emergency department with sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic strategies for treating sickle cell disease crisis related pain are mostly based on acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies are effective but may last up to half an hour to obtain pain relief. This delay mostly depends on the availability of venous access and on individual patient response to treatment. Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to allow rapid analgesia in the emergency department setting.

The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective than current analgesic strategy.

location_facility: Henri Mondor Hospital, Emergency Department


title: Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects

summary: Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further metabolism. The primary goal of this work was to measure the metabolic fate of intact or hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of this study was to assess the true ileal digestibility of dietary protein using different methods including the hydrolyzed casein method and to measure its possible effect on endogenous intestinal N losses in humans.

ReferenceCitation: Deglaire A, Moughan PJ, Airinei G, Benamouzig R, Tomé D. Intact and hydrolyzed casein lead to similar ileal endogenous protein and amino acid flows in adult humans. Am J Clin Nutr. 2020 Jan 1;111(1):90-97. doi: 10.1093/ajcn/nqz268.

ReferenceCitation: Deglaire A, Fromentin C, Fouillet H, Airinei G, Gaudichon C, Boutry C, Benamouzig R, Moughan PJ, Tomé D, Bos C. Hydrolyzed dietary casein as compared with the intact protein reduces postprandial peripheral, but not whole-body, uptake of nitrogen in humans. Am J Clin Nutr. 2009 Oct;90(4):1011-22. doi: 10.3945/ajcn.2009.27548. Epub 2009 Aug 19.

lead_sponsor: Institut National de la Recherche Agronomique

intervention_type: Dietary Supplement


title: Assessment of the Prevalence and Mutational Spectrum of Genes AHI1, NPHP1 and CEP290 in Joubert Syndrome and Cerebello-oculo-renal Syndromes

acronym: JSCORS

summary:
Primary objective:

assessment of the prevalence of AHI1 mutations in Joubert syndrome and cerebello-oculo-renal syndromes (JS/CORS)

Secondary objective:

assessment of the prevalence of CEP290 mutations and NPHP1 homozygous deletions in JS/CORS
caracterization of mutational spectrum of AHI1, NPHP1, CEP290 genes in JS/CORS.
evaluation of genotype-phenotype correlation in JS/CORS.

time_perspective: Cross-Sectional


title: Molecular Study of Factors Involved in JAK-STAT Signalling Pathway in Familial Myeloproliferative Disorders

acronym: SMP

summary: The main goal of the study is to progress in our understanding of the molecular basis of myeloproliferative disorders of the bone marrow (polycythemia vera, essential thrombocythemia, primary myelofibrosis). The study will focus on the genes encoding factors implicated in the JAK-STAT pathway which has an essential role in these diseases

location_facility: Department of Hematology, Hospital Saint Antoine


title: Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome

acronym: WPW

summary:
The study consists of the realization of a new esophageal stimulation for patients already stimulated 10 years ago.

The investigators would like to make a long term evaluation of the evolution of anterograde effective refractory period of accessory duct in the WPW syndrome.

This study will be realized by esophageal stimulation.

lead_sponsor: Nantes University Hospital


title: Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.

summary:
Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among Parkinsonian patients. However, controlled studies provided conflicting results. One of our patients showed a substantial decrease of his parkinsonian symptoms under transdermal nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent safety, especially on cardiovascular level. Otherwise, the investigators performed an open pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a controlled study. In this study, all patients received daily doses during several months until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving their motor scores.

The investigators now propose a phase II, controlled, single blind and randomised efficacy study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group without additional therapy) The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5 mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11 weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose "plateau phase", treatment will be progressively decreased by 15 mg weekly steps, over a de 6-week period followed by a five-week wash out phase.

Taking into account results from the pilot study, a long-term high doses treatment, seems to be liable to improve patients who deeply suffer from their disease. This is why the investigators now propose this monocentric institutional project.

ReferenceCitation: Villafane G, Cesaro P, Rialland A, Baloul S, Azimi S, Bourdet C, Le Houezec J, Macquin-Mavier I, Maison P. Chronic high dose transdermal nicotine in Parkinson's disease: an open trial. Eur J Neurol. 2007 Dec;14(12):1313-6. Epub 2007 Oct 17.

location_facility: Groupe Hospitalier Albert Chenevier Henri Mondor


title: Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.

lead_sponsor: Centre Antoine Lacassagne


title: Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.

acronym: FOPasa

summary:
Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography.

In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "Good medical practice" before the publication of prospective and randomised clinical studies.

time_perspective: Retrospective


title: Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival: Survival Factors in COPD Treated by Long-term Oxygen Therapy

summary:
The purpose of this prospective cohort study is to determine factors involved in survival in new COPD patients treated by long-term oxygen therapy.

Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies have been performed in the past 20-25 years to examine the results of early clinical trials. Further studies are necessary to understand the utility of oxygen therapy in severe COPD.

location_facility: Service de Pneumologie, Hôpital du Cluzeau


title: Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment

summary:
RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.


title: Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

summary:
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.


title: Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer

acronym: ENDORAD

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

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.

ReferenceCitation: Ray-Coquard I, Favier L, Weber B, Roemer-Becuwe C, Bougnoux P, Fabbro M, Floquet A, Joly F, Plantade A, Paraiso D, Pujade-Lauraine E. Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO. Br J Cancer. 2013 May 14;108(9):1771-7. doi: 10.1038/bjc.2013.183. Epub 2013 Apr 23.

ReferenceCitation: Trédan O, Treilleux I, Wang Q, Gane N, Pissaloux D, Bonnin N, Petit T, Cretin J, Bonichon-Lamichhane N, Priou F, Lavau-Denes S, Mari V, Freyer G, Lebrun D, Alexandre J, Ray-Coquard I. Predicting everolimus treatment efficacy in patients with advanced endometrial carcinoma: a GINECO group study. Target Oncol. 2013 Dec;8(4):243-51. doi: 10.1007/s11523-012-0242-9. Epub 2012 Dec 13.

lead_sponsor: ARCAGY/ GINECO GROUP


title: Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.

summary:
RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

lead_sponsor: Centre Jean Perrin


title: Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

summary: Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

ReferenceCitation: Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, François S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.

lead_sponsor: French Innovative Leukemia Organisation


title: Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3

summary: This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were assessed according to the Bladé revised IMWG criteria1 from lowest point.

lead_sponsor: AB Science


title: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study

summary:
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success.

The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effect of Monosodium Glutamate on Gastric Emptying and Postprandial Nitrogen in Healthy Volunteers

summary: There are receptors to free glutamate in the oral cavity and stomach that may mediate effects of this amino acid on gastrointestinal physiology. The investigators hypothesize that a chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the further metabolism of dietary protein in healthy subjects.

ReferenceCitation: Boutry C, Matsumoto H, Airinei G, Benamouzig R, Tomé D, Blachier F, Bos C. Monosodium glutamate raises antral distension and plasma amino acid after a standard meal in humans. Am J Physiol Gastrointest Liver Physiol. 2011 Jan;300(1):G137-45. doi: 10.1152/ajpgi.00299.2010. Epub 2010 Oct 28.


title: A Multi-center, Inpatient and Ambulatory, Phase 2, Double Blind, Randomized, Placebo-controlled Proof of Concept Study of CYR-101 in Patients With DSM-IV Schizophrenia

summary: This Phase II study will test whether CYR-101, a CNS-active compound with novel pharmacological profile and devoid of dopamine D2 receptor binding properties, is efficacious when administered orally in the management of patients with a diagnosis of DSM-IV schizophrenia.

lead_sponsor: Cyrenaic Pharmaceuticals

location_facility: Centre Hospitalier Universitaire de Nancy (CHU)


title: An Open-label, Multi-centre, Clinical Study to Collect Information on the Clinical Use of Argatroban in Patients With Heparin Induced Thrombocytopenia (HIT) Type II Who Require Parenteral Antithrombotic Therapy

summary: The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy

ReferenceCitation: Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andréani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation


title: Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

acronym: IRM 3T-SEP

summary:
It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional MRI insofar as physiopathology is not well-known: the precise sequences of events leading to plaque formation and axonal injury are still not completely understood.

Some elements involved in plaque formation can be studied thanks to MR techniques (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral microcirculation's dysfunction).

This study aims at giving a better understanding of MS plaques' physiopathology, using data from modern MRI through a longitudinal followed up with weakly MR 3T examination.

ReferenceCitation: Hannoun S, Roch JA, Durand-Dubief F, Vukusic S, Sappey-Marinier D, Guttmann CR, Cotton F. Weekly multimodal MRI follow-up of two multiple sclerosis active lesions presenting a transient decrease in ADC. Brain Behav. 2015 Feb;5(2):e00307. doi: 10.1002/brb3.307. Epub 2015 Jan 16.

lead_sponsor: Hospices Civils de Lyon

location_facility: Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique


title: PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

summary: The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.

ReferenceCitation: Lamblin G, Van-Nieuwenhuyse A, Chabert P, Lebail-Carval K, Moret S, Mellier G. A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh. Int Urogynecol J. 2014 Jul;25(7):961-70. doi: 10.1007/s00192-014-2344-7. Epub 2014 Feb 27.


title: MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study

acronym: MAP-IDM

summary:
We propose a comparative case-control study on the 2 following groups of patients:

Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct,
Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.

The primary endpoint in this study is the correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.

The first phase of the study, including patients' recruitment, clinical and biological data collection, will last 82 months. The second phase will concern the genotype/phenotype analysis and the identification of polymorphisms associated with a sudden death risk after a myocardial infarction.

This study will allow a better knowledge of the mechanisms of sudden death and the identification of new risk markers.

ReferenceCitation: Chevalier P, Moreau A, Bessière F, Richard S, Chahine M, Millat G, Morel E, Paganelli F, Lesavre N, Placide L, Montestruc F, Ankou B, Puertas RD, Asatryan B, Delinière A; MAP-IDM Investigators. Identification of Cx43 variants predisposing to ventricular fibrillation in the acute phase of ST-elevation myocardial infarction. Europace. 2022 Aug 9. pii: euac128. doi: 10.1093/europace/euac128. [Epub ahead of print]


title: Genetic Determinants of Phosphocalcic Metabolism in Hemodialysis Patients

acronym: ARNOGENE

summary: Searching for high morbi-mortality risk Klotho variants in dialysis patients

ReferenceCitation: Marçais C, Maucort-Boulch D, Drai J, Dantony E, Carlier MC, Blond E, Genet L, Kuentz F, Lataillade D, Legrand E, Moreau-Gaudry X, Jean G, Fouque D; ARNOGENE Project. Circulating Klotho Associates With Cardiovascular Morbidity and Mortality During Hemodialysis. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3154-3161. doi: 10.1210/jc.2017-00104.


title: An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects

summary: This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.

lead_sponsor: Astellas Pharma Inc


title: Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Patients Presenting a Recent Acute Coronary Syndrome.

acronym: EVANACS

summary:
The investigators' work proposes to evaluate the effectiveness of the Acid Nicotinique (Niaspan®), only molecule currently marketed, ready to raise the plasmatic levels of HDL-c. This effectiveness will be tested among patients having presented recently an acute coronary syndrome. The effectiveness of the molecule will be appreciated versus placebo after randomization.

The technique of evaluation of this effectiveness will be the analysis of the vasodilatation endothelial-dependent measured on the level huméral (by echography high resolution).

The awaited result is an improvement of 2% in value absolute of this vasodilatation between the initial test and the end of study for the patients receiving the acid nicotinic versus those receiving the placebo (3 months of treatment after inclusion). The calculation of the sample necessary to achieve this goal envisages 70 patients led at the end of the study, divided into two groups of treatment (acid nicotinic or Placebo).

Such a result if it were obtained would be higher than that found in studies evaluating the effect on the vasomotricity endothelial statins or inhibitors of the enzyme of conversion.

lead_sponsor: French Cardiology Society


title: Validation of a Semiquantitative Screening Assay for PSA

summary: The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

lead_sponsor: Institut Curie


title: Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation

summary: We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a hyperalgesia on response to thermal stimulation. A comparaison of results before and after three weeks of treatment will be made.

lead_sponsor: Lallemand SAS


summary: Clinical and neuroradiologic study concerning patients suffering of cough, exertional and sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication, redescribe clinical headaches specifications, confirmed if cough headaches is a clinical entity and if it has neuroradiologic differences with effort or sexual activity headaches.

lead_sponsor: French Society for the Study of Migraine Headache

location_facility: assistance publique hopitaux de marseille CHU Timone


title: Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases

summary:
The purpose of this study is to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases.

Randomised crossover dietary intervention study:

The main objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the lipid metabolism of volunteers as compared with the consumption of a "reference" oil.

Post prandial study:

The second objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the biomarkers of oxidative stress during post prandial period as compared with the consumption of a "reference" oil.

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand


title: Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient

summary: The purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

ReferenceCitation: Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.


title: An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of breast cancer. It is not yet known whether giving docetaxel together with a phytochemical is more effective than giving docetaxel alone in treating patients with breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a phytochemical works compared with giving docetaxel alone as first- or second-line therapy in treating patients with breast cancer.


title: Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery

summary: The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems) for Measuring Energy Expenditure at Rest and in Dynamic Phase After a Meal in Adult Healthy and Obese Volunteers

acronym: Protocol Quark

summary: Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark RMR versus Deltatrac II

primary_purpose: Health Services Research

location_facility: Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot


title: Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique

acronym: IsoTC

summary:
isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.

However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.

Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis.

ReferenceCitation: Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, Dumont R, Marie Chupin A, Peneau C, Lejus C, Blanloeil Y, Volteau C, Asehnoune K. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study. Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686.

lead_sponsor: Nantes University Hospital

location_facility: Service de Réanimation CHU de Nantes Boulevard Jean Monnet


title: Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .

acronym: NEODEC

summary: Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Neuromuscular Transmission in Amyotrophic Lateral Sclerosis

acronym: NETALS

summary: Consistent data suggest that neuromuscular transmission is impaired in ALS patients. Neuromuscular junctions dysfunction may appear very early in the disease, as shown by data in animal models. The pathogenesis of this neuromuscular transmission impairment is unknown. Nogo A isoform, a possible marker of the disease over-expressed in skeletal muscle of ALS patients, can be involved. We will characterize the pathophysiological mechanisms implicated using a complete study of the structure and function of the NMJ on muscle biopsies, in a group of 20 ALS patients compared to 10 controls.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

acronym: BCDE

summary: The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.


title: Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.

summary: To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).

lead_sponsor: UCB Pharma


title: A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

summary: The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

lead_sponsor: LEO Pharma


title: RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum

acronym: BioDNase

summary: Serine proteases belonging to the elastase family are mainly responsible for lung tissue destruction as observed during cystic fibrosis. But anti-inflammatory therapies based on systemic or aerosolized protease-inhibitors administration, have not given the expected results until now. One reason would be the impaired access of therapeutic inhibitors to their molecular targets. It was recently shown that neutrophils actively secrete neutrophil extracellular traps (NETs) made of DNA that binds cationic proteases among other molecules. NETs together with DNA passively released from dead neutrophils contribute to the viscosity of CF expectorations which explains that rhDNase treatment fluidifies expectorations and improves the patient status. Preliminary experiments in our laboratory have shown that DNA degradation was associated with a significant increase of proteolytic activity in the sputum soluble fraction. However the efficacy of exogenous inhibitors is also improved in these conditions. Using the specific substrates and methodologies that we developed previously to measure cell-surface associated proteolytic activities, we will study the effects of DNase on the activity of individual proteases, their biodistribution in sputum and their regulation by potential therapeutic inhibitors. Enzymatic, immunochemical and microscopic (confocal and scanning) techniques will first be used for ex vivo studies on sputa freshly collected at the adult and paediatric CRCM in Tours, then on sputa from patients before and after administration of aerosolized rhDNase. We hypothesize that a better understanding of the biodistribution of neutrophil serine proteases and especially their binding to DNA will help designing new therapeutic strategies that facilitate inhibitor access to their protease targets.

lead_sponsor: University Hospital, Tours


acronym: HEMOCARD

summary: the purpose of this study is to show that the vacuum control surgical bleeding helps stop bleeding extraMD (MD: Medical Device) at the orifice of the retrograde cannulation during a heart with Extra-corporeal circulation (ECC),

lead_sponsor: AdministrateurCIC


title: Efficacy and Safety of Bevacizumab for the Treatment Hemorrhagic Hereditary Telangiectasia (HHT) Associated With Severe Hepatic Vascular Malformations. Phase II Study.

acronym: METAFORE

summary:
The efficacy of anti-VEGF treatments such as Bevacizumab in cases of HHT can be considered because of the molecular mechanisms implied in angiogenesis and HHT, as well as the mechanisms of action of this type of treatment. Two articles that have recently reported spectacular improvement thanks to Bevacizumab in patients with HHT complicated with severe liver involvement and cardiac effects support us in this sense.

Up to now, the only treatment recommended in the severe hepatic forms of HHT is a liver transplant, the disadvantages of which are both multiple and well known: long waiting lists, surgical morbidity and mortality, immunosuppressive treatment for life. Furthermore, treatment with Bevacizumab is not a contraindication, should the drug be ineffective, for a subsequent liver transplant if necessary.

ReferenceCitation: Dupuis-Girod S, Ginon I, Saurin JC, Marion D, Guillot E, Decullier E, Roux A, Carette MF, Gilbert-Dussardier B, Hatron PY, Lacombe P, Lorcerie B, Rivière S, Corre R, Giraud S, Bailly S, Paintaud G, Ternant D, Valette PJ, Plauchu H, Faure F. Bevacizumab in patients with hereditary hemorrhagic telangiectasia and severe hepatic vascular malformations and high cardiac output. JAMA. 2012 Mar 7;307(9):948-55. doi: 10.1001/jama.2012.250.


title: Medical and Economical Impact of Predicting the Response to Anti-angiogenic Treatment in Metastatic Renal Cell Carcinoma Using Functional CT and MRI

acronym: REMISCAN

summary:
The goal is to study the impact of functional MRI and CT evaluation of changes in tumor vessels induced by anti-angiogenic treatment in patients with metastatic RCC.

The hypothesis is that good responders and poor responders will have different responses induced by anti-angiogenic treatment, and that the detection of theses changes by functional imaging can improve the therapeutic management.

Functional CT and MRI will be performed in 200 patients before the beginning of antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined by the RECIST criteria). Perfusion and diffusion parameters will be measured using a dedicated software.


title: Phase II Study of Treatment of Relapsed Agressive Lymphomas

summary: The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma

lead_sponsor: French Innovative Leukemia Organisation


title: ERP Study of Brain Electrophysiological Patterns in Obesity

summary: There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. We want to determine whether obesity is associated with such electrophysiological features during an auditory oddball paradigm. We postulate that obesity could be associated with electrophysiological abnormalities that could be viewed as a possible vulnerability marker for food addiction.

ReferenceCitation: Bauer LO, Hesselbrock VM. P300 decrements in teenagers with conduct problems: implications for substance abuse risk and brain development. Biol Psychiatry. 1999 Jul 15;46(2):263-72.

ReferenceCitation: Patrick CJ, Bernat EM, Malone SM, Iacono WG, Krueger RF, McGue M. P300 amplitude as an indicator of externalizing in adolescent males. Psychophysiology. 2006 Jan;43(1):84-92.

ReferenceCitation: Yoon HH, Iacono WG, Malone SM, McGue M. Using the brain P300 response to identify novel phenotypes reflecting genetic vulnerability for adolescent substance misuse. Addict Behav. 2006 Jun;31(6):1067-87. Epub 2006 Apr 27.

lead_sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe

location_facility: Centre de Recherche en Nutrition Humaine Rhone Alpes


title: Characterization and Implication of Prolactin Receptor Mutants in Human Breast Diseases

acronym: Prolacsein

summary:
Prolactin is known to play an important role in breast development and differentiation. Thus proliferative breast diseases are good models to unravel PRl / PRLR function in proliferative processes.

The aim of this project is to identify and to characterize new mutants of the prolactin receptor gene within cohorts of benign or malign breast diseases with low or high occurrence frequency in human populations


title: What Part Does the Premotor Cortex Play in Subjective Visual Perception and in the Perception of Others' Actions?

summary: This project aims at understanding better the role of the frontal lobe of the brain in our capacity to perceive visual information consciously, and also, in our capacity to perceive others' actions. It includes a test where we ask subjects to detect visual information in front of a computer screen, and another test where we ask them to imitate finger movements.


title: Evaluation of in Vitro NMR Spectroscopy to Identify Inborn Errors of Metabolism in Patients With Complex Neurological Diseases

acronym: SPECMET

summary:
The search for metabolic abnormalities in patients with neurological disorders represents an important challenge 1) to identify new potentially treatable inherited metabolic diseases, and 2) to identify biomarkers or new treatments in more common neurodegenerative or neurogenetic disorders.

This approach is currently limited by the fact that techniques aiming at identifying abnormal metabolites in human fluids (metabolomics) only detect subsets of molecules and that no general assays is available to detect abnormalities in the metabolism of complex molecules that takes place within cell organelles. As a consequence, only limited parts of the metabolism can be studied simultaneously.

The aim of this study is to evaluate whether NRM spectroscopy of body fluids (urines, cerebrospinal fluid) could allow to detect new metabolic abnormalities in patients with complex neurological diseases.

location_facility: Neurology department, Pitié-Salpêtrière Hospital


title: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma

summary: Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.

ReferenceCitation: Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Béné MC, Delwail V; LYSA Group. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.

ReferenceCitation: Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.


title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

summary:
This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.

Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.

ReferenceCitation: Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.

lead_sponsor: Hospices Civils de Lyon


title: A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS

summary:
RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia.

lead_sponsor: Institut Paoli-Calmettes

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


title: Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

acronym: EFU

summary: The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.


title: Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.

acronym: LICITE

summary: The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.

location_facility: Service de Médecine Physique et de Réadaptation - Hôpital BICHAT


title: Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

summary: The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

lead_sponsor: Bayer


title: Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.

summary: The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations


title: Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy

acronym: NEURODIAB

summary: The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.

ReferenceCitation: Lecleire-Collet A, Audo I, Aout M, Girmens JF, Sofroni R, Erginay A, Le Gargasson JF, Mohand-Saïd S, Meas T, Guillausseau PJ, Vicaut E, Paques M, Massin P. Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy. Invest Ophthalmol Vis Sci. 2011 May 2;52(6):2861-7. doi: 10.1167/iovs.10-5960.


title: Evaluation of a Mechanical Insufflation-exsufflation Device During Acute Respiratory Failure in Patients With Neuromuscular Disorders: a Prospective, Randomized, Controlled, Multicenter Study

acronym: Nemucough

summary: The hypothesis is that a mechanical insufflation-exsufflation (MI-E) is associated with a decrease in the number of intubations and more rapid clinical improvement in children and adults with neuromuscular disease who are admitted for an acute respiratory exacerbation.In this prospective, randomised, multicenter study, 55 patients will be treated with standard treatment and a MI-E, and 55 patients with standard treatment and standard respiratory physiotherapy. The primary objective is the reduction of the number of patients requiring invasive ventilatory support (endotracheal intubation or tracheotomy) in the group treated with MI-E (MI-E group). The main secondary objectives are a reduction in hospital stay and an improvement in clinical condition, dyspnea and respiratory muscle function.

location_facility: Hospital Armand Trousseau, Pediatric Pulmonology Department and INSERM UMR S-893


title: Cataract Surgery Benefice in Improvement of Behaviour, Autonomy and Mood for Alzheimer Patients.

acronym: VIVA

summary: The VIVA study is focused on Alzheimer's disease patients with a low vision due to a bilateral cataract. The aim is to study cataract surgery results on patients' autonomy, behaviour, and mood. In fact those dement elderly patients suffer from a progressive loss of superior functions, with loss of autonomy, behaviour and mood degradation, associated with physical disabilities. The work hypothesis is that a loss of sensorial functions, particularly visual, is an aggravating factor of NEURO-cognitive troubles and absence of communication with outside circle. The protocol consists in investigating superior functions, autonomy, and behaviour troubles of the participating patients, with the help of a series of neuropsychological tests used one month before and three months after cataract operation on the eye with the worst vision. Independently of the study, patients must have given an informed consent to cataract surgery. Their participation lasts 4 months+/- 1 month. The aim of the study is to evaluate whether the cataract surgery improves patients' behaviour, autonomy and mood and possibly to show evidence onf drawbacks in of such a practice.The main objective targets to cataract surgery benefice on patients suffering from both Alzheimer's disease and impeding cataract, aiming to improve behaviour troubles. The specific objective is to measure this benefice in correlation with visual acuity improvement.

intervention_type: Behavioral


title: A Double Blind Randomized, Placebo-controlled, Cross-over Trial to Evaluate the Efficiency of a Mouthrinse, Containing Red Grape Seed Extract and nicométhanol Fluorhydrate, in the Control of Dental Plaque Deposit in a 4-days Plaque Regrowth Model

acronym: Bain de bouche

summary:
The objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits.

The study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.

ReferenceCitation: Addy M. Evaluation of clinical trials of agents and procedures to prevent caries and periodontal disease: choosing products and recommending procedures. Int Dent J. 1995 Jun;45(3):185-96. Review.

ReferenceCitation: Guidelines for acceptance of chemotherapeutic products for the control of supragingival dental plaque and gingivitis. Council on Dental Therapeutics. J Am Dent Assoc. 1986 Apr;112(4):529-32.

ReferenceCitation: Yates RJ, Shearer BH, Morgan R, Addy M. A modification to the experimental gingivitis protocol to compare the antiplaque properties of two toothpastes. J Clin Periodontol. 2003 Feb;30(2):119-24.

ReferenceCitation: Furiga A, Lonvaud-Funel A, Dorignac G, Badet C. In vitro anti-bacterial and anti-adherence effects of natural polyphenolic compounds on oral bacteria. J Appl Microbiol. 2008 Nov;105(5):1470-6. doi: 10.1111/j.1365-2672.2008.03882.x. Epub 2008 Sep 13.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital ST André - 1 rue Jean Burguet


title: Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.

acronym: EXAOS

summary:
The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.

The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).

Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.

Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.

Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.

Methodology: Test physiopathological parallel group, controlled, randomized.

lead_sponsor: University Hospital, Grenoble


title: MESenchymal Stem Cells: Alterations in GEnome

acronym: MESSAGE

summary: The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.


title: Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact

acronym: SNA&Sepsis

summary: Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.


title: Multi Marker Approach Interest in Emergency in Acute Respiratory Insufficiency Diagnostic

acronym: BIO-IRA

summary:
Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear.

We propose to determine the more relevant marker combination in this case.


title: Chronic Pain After Thoracotomy, an Incidence Study in a Single Surgical Center

summary: Investigation of chronic pain frequency after thoracotomy for lung cancer. Risk factors for development of chronic pain are investigated. Questionnaire survey.

lead_sponsor: Hopital Foch


title: Interest of Repeated Extravascular Lung Water Measurements With the PICCO Device in Lung Transplanted Patients

acronym: PICCO-LungT

summary: Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation


title: Evaluation of Apathy Using Attentional Reaction Test in Neurodegenerative Diseases

summary:
Apathy, defined as a lack of motivation in behaviour, cognition and affect, is common in neurodegenerative diseases. Specific scales are available for the evaluation of apathy but it lacks objective evaluation methods.

The aim of this study is to evaluate the changes in reaction time task according to the presence or absence of reward stimulation and to assess the relation between these performances and apathy scales.

lead_sponsor: Centre Hospitalier Universitaire de Nice