title: Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo

acronym: ZODIAC

summary: The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with 14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.

ReferenceCitation: Boccon-Gibod I, Bouillet L. [Angioedema and urticaria]. Ann Dermatol Venereol. 2014 Nov;141 Suppl 3:S586-95. doi: 10.1016/S0151-9638(14)70162-0. French.

ReferenceCitation: Pagnier A. [Hereditary angioedema in childhood. Diagnosis and therapeutic challenges]. Presse Med. 2015 Jan;44(1):89-95. doi: 10.1016/j.lpm.2014.07.018. Epub 2014 Dec 12. French.

ReferenceCitation: Dinkel HP, Maroske J, Schrod L. Sonographic appearances of the abdominal manifestations of hereditary angioedema. Pediatr Radiol. 2001 Apr;31(4):296-8. doi: 10.1007/s002470000409.

ReferenceCitation: Bygum A. Hereditary angio-oedema in Denmark: a nationwide survey. Br J Dermatol. 2009 Nov;161(5):1153-8. doi: 10.1111/j.1365-2133.2009.09366.x. Epub 2009 Jun 22.

ReferenceCitation: Farkas H. Pediatric hereditary angioedema due to C1-inhibitor deficiency. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):18. doi: 10.1186/1710-1492-6-18.

ReferenceCitation: El-Hachem C, Amiour M, Guillot M, Laurent J. [Hereditary angioneurotic edema: a case report in a 3-year-old child]. Arch Pediatr. 2005 Aug;12(8):1232-6. doi: 10.1016/j.arcped.2005.03.052. French.

ReferenceCitation: Farkas H. Management of upper airway edema caused by hereditary angioedema. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):19. doi: 10.1186/1710-1492-6-19.

ReferenceCitation: Sanchez A, Ecochard A, Maestracci M, Rodiere M. [Hereditary angioedema causing colocolic intussusception]. Arch Pediatr. 2008 Mar;15(3):271-4. doi: 10.1016/j.arcped.2007.12.004. Epub 2008 Mar 10. French.

ReferenceCitation: Pritzker HA, Levin TL, Weinberg G. Recurrent colocolic intussusception in a child with hereditary angioneurotic edema: reduction by air enema. J Pediatr Surg. 2004 Jul;39(7):1144-6. doi: 10.1016/j.jpedsurg.2004.03.075.

ReferenceCitation: Parisi G, Chiarelli A, Squadrone NP, Galante E. Hereditary angioedema, a rare cause of recurrent abdominal pain. A report of 2 clinical cases and comments of a general nature Allergy Asthma Proc. 2013 Jul-Aug;34(4):312-27

ReferenceCitation: MacGinnitie AJ. Pediatric hereditary angioedema. Pediatr Allergy Immunol. 2014 Aug;25(5):420-7. doi: 10.1111/pai.12168. Epub 2013 Dec 9.

ReferenceCitation: Deroux A, Vilgrain I, Dumestre-Perard C, Boccon-Gibod I, Bouillet L. Towards a specific marker for acute bradykinin-mediated angioedema attacks: a literature review. Eur J Dermatol. 2015 Jul-Aug;25(4):290-5. doi: 10.1684/ejd.2015.2547.

ReferenceCitation: Nussberger J, Cugno M, Cicardi M. Bradykinin-mediated angioedema. N Engl J Med. 2002 Aug 22;347(8):621-2. doi: 10.1056/NEJM200208223470820. No abstract available.

ReferenceCitation: Cugno M, Zanichelli A, Bellatorre AG, Griffini S, Cicardi M. Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency. Allergy. 2009 Feb;64(2):254-7. doi: 10.1111/j.1398-9995.2008.01859.x. Epub 2008 Dec 4.

ReferenceCitation: Hogan AD, Schwartz LB. Markers of mast cell degranulation. Methods. 1997 Sep;13(1):43-52. doi: 10.1006/meth.1997.0494.

ReferenceCitation: Brickman CM, Frank MM, Kaliner M. Urine-histamine levels in patients with hereditary angioedema (HAE). J Allergy Clin Immunol. 1988 Sep;82(3 Pt 1):403-6. doi: 10.1016/0091-6749(88)90012-7.

ReferenceCitation: Payne V, Kam PC. Mast cell tryptase: a review of its physiology and clinical significance. Anaesthesia. 2004 Jul;59(7):695-703. doi: 10.1111/j.1365-2044.2004.03757.x.

ReferenceCitation: Kasperska-Zajac A, Grzanka A, Czecior E, Misiolek M, Rogala B, Machura E. Acute phase inflammatory markers in patients with non-steroidal anti-inflammatory drugs (NSAIDs)-induced acute urticaria/angioedema and after aspirin challenge. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1048-52. doi: 10.1111/j.1468-3083.2012.04486.x. Epub 2012 Feb 21.

ReferenceCitation: Fujii K, Konishi K, Kanno Y, Ohgou N. Acute urticaria with elevated circulating interleukin-6 is resistant to anti-histamine treatment. J Dermatol. 2001 May;28(5):248-50. doi: 10.1111/j.1346-8138.2001.tb00126.x.

ReferenceCitation: Kasperska-Zajac A, Brzoza Z. Increased D-dimer concentration in plasma of patients with severe acute urticaria. Br J Dermatol. 2009 Dec;161(6):1409-10. doi: 10.1111/j.1365-2133.2009.09466.x. Epub 2009 Sep 15. No abstract available.

ReferenceCitation: Brevet: w/o 2008 062314 circulating ve-cadherin as a predictive marker of sensitivity or resistance to anti-tumoral treatment, and improved method for the detection of soluble proteins.

ReferenceCitation: Bouillet L, Sidibe A, Polena H, Mannic T, Deroux A, Stidder B, Vittecoq O, Vilgrain I. [Endothelial junctions: exploiting their instability in the development of biomarkers for vascular remodelling]. Med Sci (Paris). 2014 Jun-Jul;30(6-7):633-5. doi: 10.1051/medsci/20143006012. Epub 2014 Jul 11. No abstract available. French.

ReferenceCitation: Bouillet L, Vilgrain I. VE-cadherin, a potential marker for endothelial cell activation during hereditary angioedema attacks. J Allergy Clin Immunol. 2014 Jul;134(1):241. doi: 10.1016/j.jaci.2014.04.016. Epub 2014 May 27. No abstract available.

ReferenceCitation: Sidibe A, Polena H, Pernet-Gallay K, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Marechal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. VE-cadherin Y685F knock-in mouse is sensitive to vascular permeability in recurrent angiogenic organs. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H455-63. doi: 10.1152/ajpheart.00774.2013. Epub 2014 May 23.

ReferenceCitation: Sidibe A, Polena H, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Marechal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. Dynamic phosphorylation of VE-cadherin Y685 throughout mouse estrous cycle in ovary and uterus. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H448-54. doi: 10.1152/ajpheart.00773.2013. Epub 2014 May 23.

ReferenceCitation: Bouillet L, Mannic T, Arboleas M, Subileau M, Massot C, Drouet C, Huber P, Vilgrain I. Hereditary angioedema: key role for kallikrein and bradykinin in vascular endothelial-cadherin cleavage and edema formation. J Allergy Clin Immunol. 2011 Jul;128(1):232-4. doi: 10.1016/j.jaci.2011.02.017. Epub 2011 Mar 24. No abstract available.

ReferenceCitation: Suffritti C, Zanichelli A, Maggioni L, Bonanni E, Cugno M, Cicardi M. High-molecular-weight kininogen cleavage correlates with disease states in the bradykinin-mediated angioedema due to hereditary C1-inhibitor deficiency. Clin Exp Allergy. 2014 Dec;44(12):1503-14. doi: 10.1111/cea.12293.

ReferenceCitation: Kahn R, Herwald H, Muller-Esterl W, Schmitt R, Sjogren AC, Truedsson L, Karpman D. Contact-system activation in children with vasculitis. Lancet. 2002 Aug 17;360(9332):535-41. doi: 10.1016/S0140-6736(02)09743-X.

ReferenceCitation: Ghannam A, Sellier P, Defendi F, Favier B, Charignon D, Lopez-Lera A, Lopez-Trascasa M, Ponard D, Drouet C. C1 inhibitor function using contact-phase proteases as target: evaluation of an innovative assay. Allergy. 2015 Sep;70(9):1103-11. doi: 10.1111/all.12657. Epub 2015 Jun 9.

ReferenceCitation: Adam SS, Key NS, Greenberg CS. D-dimer antigen: current concepts and future prospects. Blood. 2009 Mar 26;113(13):2878-87. doi: 10.1182/blood-2008-06-165845. Epub 2008 Nov 13.

ReferenceCitation: Blohme G. Treatment of hereditary angioneurotic oedema with tranexamic acid. A random double-blind cross-over study. Acta Med Scand. 1972 Oct;192(4):293-8. doi: 10.1111/j.0954-6820.1972.tb04818.x. No abstract available.

ReferenceCitation: Brown NJ, Gainer JV, Stein CM, Vaughan DE. Bradykinin stimulates tissue plasminogen activator release in human vasculature. Hypertension. 1999 Jun;33(6):1431-5. doi: 10.1161/01.hyp.33.6.1431.

ReferenceCitation: Cugno M, Hack CE, de Boer JP, Eerenberg AJ, Agostoni A, Cicardi M. Generation of plasmin during acute attacks of hereditary angioedema. J Lab Clin Med. 1993 Jan;121(1):38-43.

ReferenceCitation: Frank MM, Sergent JS, Kane MA, Alling DW. Epsilon aminocaproic acid therapy of hereditary angioneurotic edema. A double-blind study. N Engl J Med. 1972 Apr 13;286(15):808-12. doi: 10.1056/NEJM197204132861503. No abstract available.

ReferenceCitation: Joseph K, Tholanikunnel BG, Wolf B, Bork K, Kaplan AP. Deficiency of plasminogen activator inhibitor 2 in plasma of patients with hereditary angioedema with normal C1 inhibitor levels. J Allergy Clin Immunol. 2016 Jun;137(6):1822-1829.e1. doi: 10.1016/j.jaci.2015.07.041. Epub 2015 Sep 26.

ReferenceCitation: Kaplan AP, Austen KF. A prealbumin activator of prekallikrein. II. Derivation of activators of prekallikrein from active Hageman factor by digestion with plasmin. J Exp Med. 1971 Apr 1;133(4):696-712. doi: 10.1084/jem.133.4.696.

ReferenceCitation: Kleniewski J, Blankenship DT, Cardin AD, Donaldson V. Mechanism of enhanced kinin release from high molecular weight kininogen by plasma kallikrein after its exposure to plasmin. J Lab Clin Med. 1992 Jul;120(1):129-39.

ReferenceCitation: Kluft C, Trumpi-Kalshoven MM, Jie AF, Veldhuyzen-Stolk EC. Factor XII-dependent fibrinolysis: a double function of plasma kallikrein and the occurrence of a previously undescribed factor XII- and kallikrein-dependent plasminogen proactivator. Thromb Haemost. 1979 Jun 30;41(4):756-73.

ReferenceCitation: Nielsen EW, Johansen HT, Hogasen K, Wuillemin W, Hack CE, Mollnes TE. Activation of the complement, coagulation, fibrinolytic and kallikrein-kinin systems during attacks of hereditary angioedema. Scand J Immunol. 1996 Aug;44(2):185-92. doi: 10.1046/j.1365-3083.1996.d01-298.x.

ReferenceCitation: Reshef A, Zanichelli A, Longhurst H, Relan A, Hack CE. Elevated D-dimers in attacks of hereditary angioedema are not associated with increased thrombotic risk. Allergy. 2015 May;70(5):506-13. doi: 10.1111/all.12587. Epub 2015 Feb 23.

location_facility: Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes


type: Other Identifier

title: Physical Exercise and Neuromuscular Diseases: Pilot Study of an Innovative Physiotherapy in Patients With Infantile Spinal Muscular Atrophy

acronym: ExerASI

summary:
This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3 Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific exercise should promote motor skills of trained patients, as we have observed in different mouse models. Patient's motor skills will be assessed using different scales including MFM and Hammersmith.

This clinical trial attempts to develop a new non-invasive motor scale with sophisticated instruments.

This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of currently available scales.

In addition, the study attempts to validate a questionnaire on post-exercise physical well-being.

study_start_date_type: Actual

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: Other

lead_sponsor_type: academique

status_simplified: Completed


title: The Impact of Systematic Psychological and Medical Care for Treatment of Pediatric Patients With SCD: : A Luxury or a Necessity?

acronym: Drépano

summary: Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model used is systematic psychological and medical care. Our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Behavioral

lead_sponsor_type: industriel


title: Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation

summary: The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.

lead_sponsor: MEDA Pharma GmbH & Co. KG

location_facility: Hopital Cardiologique, Service de Cardiologique CHR de Lille

intervention_type: Drug


title: USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study

acronym: USTAP

summary:
Phase IV

Trial design : Multicentre, randomized, double-blind, placebo-controlled study

Population : Moderate to severe Crohn's disease with at least one active perianal fistula track

Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg) followed by UST SubCutaneous (SC) 90mg every 8 weeks. Group 2: Placebo IV followed by Placebo SC The trial duration for each patient will be 48 weeks.

Trial objective : To evaluate the efficacy and safety of ustekinumab in fistulizing perianal Crohn's disease.

Number of patients : A total of 146 patients will be included in 20 sites in France

Trial duration : First patient in: Q3 2020 - Last patient first visit: Q3 2022 Last patient last visit: Q3 2023

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility: CHU Nîmes - Hôpital Universitaire Caremeau

status_simplified: Ongoing


title: Prospective, Monocentric Study Comparing Cystectomy to PlasmaJet Ablation in the Surgical Management of Ovarian Endometriomas

summary:
Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation using the PlasmaJet system versus cystectomy, using postoperative examination by 3D ultrasound.

Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two University tertiary referral centers.

Patients: Fifty women with no previous history of ovarian surgery managed for unilateral ovarian endometrioma > 30 mm in diameter.

Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian tissue sparing cystectomy.

Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume and antral follicle count (AFC) .

status: Unknown status

ReferenceType: derived

ReferenceCitation: Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3):e2014.00002. doi: 10.4293/JSLS.2014.00002.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: hybrid

publisher_dissemination: The Society of Laparoscopic and Robotic Surgeons

lead_sponsor: Plasma Surgical Inc

intervention_type: Procedure

status_simplified: Unknown


title: Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"

summary: In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.

status: Terminated

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M, DeVita MA, Rosenbaum SH, Rothenberg DM, Sprung CL, Webb SA, Wlody GS, Hurford WE. Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med. 2001 Dec;29(12):2332-48. doi: 10.1097/00003246-200112000-00017. No abstract available.

ReferenceType: result

ReferenceCitation: Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hopital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hopital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.

ReferenceCitation: Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14. doi: 10.1016/s0140-6736(00)03564-9.

ReferenceCitation: Ferrand E, Lemaire F, Regnier B, Kuteifan K, Badet M, Asfar P, Jaber S, Chagnon JL, Renault A, Robert R, Pochard F, Herve C, Brun-Buisson C, Duvaldestin P; French RESSENTI Group. Discrepancies between perceptions by physicians and nursing staff of intensive care unit end-of-life decisions. Am J Respir Crit Care Med. 2003 May 15;167(10):1310-5. doi: 10.1164/rccm.200207-752OC. Epub 2003 Jan 24.

ReferenceCitation: Ferrand E, Marty J; French LATASAMU Group. Prehospital withholding and withdrawal of life-sustaining treatments. The French LATASAMU survey. Intensive Care Med. 2006 Oct;32(10):1498-505. doi: 10.1007/s00134-006-0292-5. Epub 2006 Aug 2.

ReferenceCitation: Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.

ReferenceCitation: Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7. doi: 10.1001/jama.290.6.790.

ReferenceCitation: Ferrand E, Jabre P, Fernandez-Curiel S, Morin F, Vincent-Genod C, Duvaldestin P, Lemaire F, Herve C, Marty J. Participation of French general practitioners in end-of-life decisions for their hospitalised patients. J Med Ethics. 2006 Dec;32(12):683-7. doi: 10.1136/jme.2005.014084.

ReferenceCitation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

ReferenceCitation: Kelley AS, Meier DE. Palliative care--a shifting paradigm. N Engl J Med. 2010 Aug 19;363(8):781-2. doi: 10.1056/NEJMe1004139. No abstract available.

ReferenceCitation: Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.

ReferenceCitation: Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Medical Association

ipd_sharing: No

lead_sponsor: Hopital Foch

location_facility:
Hôpital Avicenne
Hôpital Ambroise Paré
Centre Hospitalier de Soissons
Groupe Hospitalier Paris - Saint-Joseph
Hiopital Foch Néphrologie
Hopital privé Oncologie Médicale
Hopital Lariboisiere Medecine interne
Hopîtal Foch Urgences
Hopital Foch Cardiologie
Centre Hospitalier
Hôpital Privé Medecine interne
Hôpital Bicêtre
Hopital Foch Neurochirurgie
CH
CHRU
Hôpital Georges Clemenceau
Hopital Foch Médecine Interne
CHU
Hopital Foch Chirurgie Urologique
Hopital Cochin Gastro-Enterologie
Centre Hospitalier Universitaire


title: Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.

summary: The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

lead_sponsor: Institut Curie

collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer

summary: Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w).

ReferenceCitation: Lerouge D, Riviere A, Dansin E, Chouaid C, Dujon C, Schott R, Lavole A, Le Pennec V, Fabre E, Crequit J, Martin F, Dehette S, Fournel P, Precheur-Agulhon B, Lartigau E, Zalcman G. A phase II study of cisplatin with intravenous and oral vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy with oral vinorelbine and cisplatin for locally advanced non-small cell lung cancer. BMC Cancer. 2014 Mar 30;14:231. doi: 10.1186/1471-2407-14-231.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Pierre Fabre Medicament


title: Does Patient Look to Internet for Anesthesia Information Before Surgery : a Prospective International Questionaire Study

acronym: e-anesth

summary: Patients need information for perioperative period and internet may be an interesting alternative.This study analysed by questionaire what does patient look on internet: information of perioperative period and specifically for anesthesia. Questionaire (8 questions) are distributed to the patient before surgery and after they were prepared by surgeon. Population : adult (> 18 y), no emergency procedure.The mean question is the use of internet for anesthesia information.

time_perspective: Prospective

ReferenceCitation: Nucci B, Claret PG, Leclerc G, Chaumeron A, Grillo P, Buleon C, Leprince V, Raux M, Minville V, Futier E, Lefrant JY, Cuvillon P; Anaesthesia Internet Study Group. Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey. Eur J Anaesthesiol. 2017 Dec;34(12):831-835. doi: 10.1097/EJA.0000000000000686.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Pierre and Marie Curie University

location_facility:
CHU Toulouse
CHU Caremeau


title: Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients

acronym: UPtimum-PsA

summary:
Psoriatic arthritis (PsA) is a chronic, immune-mediated, systemic disease affecting less than 1% of people with variations by parts of the world, and around 20%-30% of participants with psoriasis.

Upadacitinib (RINVOQ) is approved drug for the treatment of adult participants with active PsA in Europe. Approximately 450 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 4 countries in Europe: France, Germany, Greece and Italy.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 24 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_country: Germany Italy Greece France

location_facility: CHU Toulouse - Hopital Purpan /ID# 252077

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 252078

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 250817

location_facility: Universita degli Studi del Molise /ID# 251176

location_facility: CH AIX LES BAIN - Reine Hortense /ID# 252465

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 252532

location_facility: Krankenhaus der Barmherzigen Brueder Trier /ID# 254762

location_facility: Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 250669

location_facility: Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 251146

location_facility: CHU Grenoble - Hopital Michallon /ID# 252601

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 251508

location_facility: Fondazione IRCCS Policlinico /ID# 250747

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544

location_facility: ELSAN - Clinique du Pont de Chaume /ID# 252602

location_facility: General Hospital of Athens Laiko /ID# 247634

location_facility: General Hospital of Elefsina Thriassio /ID# 251900

location_facility: Universitaetsmedizin Greifswald /ID# 254756

location_facility: GH Diaconesses Croix Saint-Simon /ID# 252463

location_facility: CH La Rochelle - Hopital Saint Louis /ID# 252534

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 251183

location_facility: Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 247643

location_facility: Cabinet Du Dr Judith Payet Dubourg /Id# 252668

location_facility: MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 247632

location_facility: University General Hospital of Ioannina /ID# 251899

location_facility: CHU Amiens-Picardie Site Sud /ID# 252527

location_facility: CHR Orleans - Hopital de la Source /ID# 252530

location_facility: CH Troyes - Hopital Simone Veil /ID# 252625

location_facility: University General Hospital Attikon /ID# 248093

location_facility: General Hospital of Athens Ippokratio /ID# 247633

location_facility: Henry Dunnant Hospital Center /ID# 247640

location_facility: General Hospital of Athens Laiko /ID# 258030

location_facility: 251 Airforce General Hospital /ID# 248092

location_facility: General Hospital of Athens Gennimatas /ID# 247635

location_facility: Centre Hospitalier de Boulogne Sur Mer /ID# 252467

location_facility: Cabinet libéral du Dr PAUPIERE /ID# 252604

location_facility: CHU de Rennes - Hospital Sud /ID# 252478

location_facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 250789

location_facility: Euromedica Blue Cross Gen Clin /ID# 251898

location_facility: KAT Atttica General Hospital /ID# 247641

location_facility: Kupka & Kupka, Altenburg, DE /ID# 254758

location_facility: CHRU Tours - Hopital Trousseau /ID# 252528


title: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms

summary: To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg

lead_sponsor: InnFocus Inc.

location_facility: Clinique Mutualiste - Pavillon Ophtalmogique

intervention_type: Device


title: Adipose Tissue Involvement in Alcohol-induced Liver Inflammation in Human : Study of Pro- and Anti-inflammatory Cytokines and ADIPOKINES..

acronym: RIHTA

summary:
The histological characteristics of alcoholic liver disease (ALD) and non-alcoholic steatohepatitis (NASH) related to overweight and obesity suggest the presence of partly common physiopathological mechanisms. We reported that the ponderal overload was an independent risk factor of alcoholic cirrhosis. The adipose tissue was considered for a long time as a simple place of storage of fat. However, it is now recognized that the adipose tissue can secrete cytokines called ADIPOKINES.

The adipose tissue can secrete others cytokines such as TNF-alpha, IL6, IL10 and IL1-Ra. Increase in the production of the leptin and TNF-alpha by the adipose tissue after alcohol administration in the rat, as well as the role of leptin in inflammation and liver fibrogenesis in the murine model of chemical hepatotoxicity strongly suggest that activation of adipocytes by alcohol can explain the strong correlation observed between the body mass index (BMI) and the severity of ethanol-induced liver injury. Conversely, it was suggested in a murine model that the reduction in adiponectin production would sensitize the liver with the toxicity of alcohol. The PPAR alpha and gamma are the receptors which play a role both in inflammation and glucide and lipid metabolism. Taking into account the inhibiting role of PPAR alpha on the proliferation of the hepatic stellate cells, responsible for the fibrosis, the PPAR could also be implied in the relation between the overweight and the hepatic fibrosis in the alcoholic.

primary_purpose: Basic Science

ReferenceCitation: Voican CS, Njike-Nakseu M, Boujedidi H, Barri-Ova N, Bouchet-Delbos L, Agostini H, Maitre S, Prevot S, Cassard-Doulcier AM, Naveau S, Perlemuter G. Alcohol withdrawal alleviates adipose tissue inflammation in patients with alcoholic liver disease. Liver Int. 2015 Mar;35(3):967-78. doi: 10.1111/liv.12575. Epub 2014 Jun 3.

publisher_dissemination: Wiley


title: Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis

summary: Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.

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


title: An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products

summary:
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.

The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.

The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.

Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.

The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.

100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.

lead_sponsor: Coloplast A/S

location_country: Germany Denmark Iceland France

location_facility:
Landspitali University Hospital
Sygehus Sønderjylland i Aabenraa
Odense Universitetshospital
CHRU La Milétrie
Hôpital de Pontchaillou, CHRU de Rennes
Bispebjerg Hospital
Hôpital Lariboisière
Hôpital Nord
Hvidovre Hospital
Sanitätshaus Fürst GmbH
Hôpital Hôtel Dieu de Nantes


title: Assessment of 18Fluoro-thymidine PET-CT for the Volume Definition of High-grade Gliomas (GLIO-TEP) : Correlation With Histopathology

acronym: GLIO-TEP

summary: 18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation. Very few data report an interest of using such a tracer for cerebral malignant tumor management. In our project, we want to compare the tumoral volumes obtained with PET and MRI, with the gold standard histopathological diagnosis according to the WHO grading malignancy scale and the Ki-67 proliferation index, for preoperative evaluation as much as for tumoral postoperative residue evaluation. Furthermore, we want to explore the interest of 18F-FLT-PET volume to better delineate tumoral volume in radiotherapeutic management of gliomas.

primary_purpose: Diagnostic

ReferenceCitation: Choi SJ, Kim JS, Kim JH, Oh SJ, Lee JG, Kim CJ, Ra YS, Yeo JS, Ryu JS, Moon DH. [18F]3'-deoxy-3'-fluorothymidine PET for the diagnosis and grading of brain tumors. Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):653-9. doi: 10.1007/s00259-004-1742-3. Epub 2005 Feb 15.

ReferenceCitation: Chen W, Cloughesy T, Kamdar N, Satyamurthy N, Bergsneider M, Liau L, Mischel P, Czernin J, Phelps ME, Silverman DH. Imaging proliferation in brain tumors with 18F-FLT PET: comparison with 18F-FDG. J Nucl Med. 2005 Jun;46(6):945-52.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Pellegrin-tripode , CHU de Bordeaux

intervention_type: Radiation


title: Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus

acronym: TROPOPLUS

summary: Identification of biological markers able to better stratify cardiovascular risks in systemic lupus erythematosus patients is needed. We aimed to determine whether serum cardiac troponin T levels measured with a highly sensitive assay (HS-cTnT) may predict cardiovascular events in systemic lupus erythematosus.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Roche Diagnostics


title: Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification

acronym: LongCRY

summary:
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.

The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants".

From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby.

Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities.

Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent.

However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks

acronym: HAPI

summary: Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU) with significant complications and morbidity. Patient desaturation is one of the most common complications that may lead to cardiac arrest despite pre-intubation oxygenation. Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can be cumbersome to implement in the context of urgent intubation and more importantly it does not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a technique that has been shown to improve patient oxygenation in the context of acute hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study is to compare pre- and per-intubation (during intubation) oxygenation with either a conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).

ReferenceCitation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

ReferenceCitation: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.

ReferenceCitation: Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.

ReferenceCitation: Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.

ReferenceCitation: Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbe V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.

lead_sponsor: Hôpital Louis Mourier


title: Randomized, Double-blind, Placebo and Active Controlled Study of the Activity of SAR407899A Single-dose on the Ability to Increase Duration of Penile Rigidity, Under Experimental Condition, in Patients With Mild to Moderate Erectile Dysfunction (ED).

acronym: RHOKET

summary:
The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.

The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.

lead_sponsor: Sanofi


title: Safety and Effects on Blood Pressure of Daily Dose 0.025 to 0.135 Milligram Per Kilogram of S90625 a Paediatric Formulation of Perindopril, in Hypertensive Children - 24 Months

summary: The aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children

ipd_sharing: Yes

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies in patients:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier


title: Digital Preop-planning of Total Hip Arthroplasties in Orthopedic

acronym: PLANORTHO

summary: Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

lead_sponsor: University Hospital, Toulouse


title: Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.

acronym: LECG

summary:
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine.

The purpose of the study is to obtain more data on leadless ECG to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.

ipd_sharing_description: No sharing

lead_sponsor: Medtronic Bakken Research Center


title: Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis

acronym: URSONASH

summary:
This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.

The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.

The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.

lead_sponsor: Axcan Pharma


type: Registry Identifier

title: AROPE : Early Ovarian Reserve Decreased : Impact of Exposure to Persistent Endocrine Disruptors and Organic Solvents

acronym: AROPE

summary:
Early ovarian reserve decreased is one of the main causes of infertility for women after 35 years. The relationship between this decreased and exposure to chemicals, including persistent endocrine disruptors or organic solvents, has been little studied. However, several in vivo or in vitro experimental studies suggested that these chemicals may impaired ovarian function.

The main objective is to study the relationship between early ovarian reserve decreased and exposure to persistent organic pollutants.

The secondary objectives are to study the relationship between early ovarian reserve decreased and exposure to organic solvents and heavy metals.

Multicenter case-control study. This project will permit to increase the knowledge concerning the etiology of early decreased ovarian reserve. Considering that exposure of interest are frequent, the results may be important in a public health perspective. If associations are observed in this study, the results may encouraged prevention strategy.

primary_purpose: Other

ReferenceCitation: Genard-Walton M, Warembourg C, Duros S, Mercier F, Lefebvre T, Guivarc'h-Leveque A, Le Martelot MT, Le Bot B, Jacquemin B, Chevrier C, Cordier S, Costet N, Multigner L, Garlantezec R. Serum persistent organic pollutants and diminished ovarian reserve: a single-exposure and mixture exposure approach from a French case-control study. Hum Reprod. 2023 Apr 3;38(4):701-715. doi: 10.1093/humrep/dead028.

publisher_dissemination: Oxford University Press

lead_sponsor: Rennes University Hospital

location_facility:
Clinique Mutualiste de La Sagesse
Nantes university hospital
Cabinet de Gynécologie Malakoff
Brest university hospital
Rennes university hospital


title: Observational Cohort Study to Characterise the Current Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients Hospitalised in Intensive Care Units in Europe

summary:
The aim of this study is to characterise the use of clinical nutrition support, especially of parenteral nutrition that is administered directly into a vein, in adult patients with critical illness. The study wants to assess nutritional balance (that means the ratio of calories and protein prescribed to calories and protein actually received). Furthermore, it wants to evaluate whether the nutrition received has influence on the patients' clinical outcome, with focus on measures of physical function, such as capability of conducting daily living activities. As the study is "observational", no specific medications or treatments will be provided as part of the study to the patients.

Study patients will be observed during their stay on an intensive care unit, for a maximum duration of 15 days. Furthermore, questions on the well-being of the patients will be asked via telephone interviews 30 and 90 days after their admission to the intensive care unit.

Data of approximately 1250 patients will be collected and evaluated in this study, from approximately 100 hospitals in 11 European countries (Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, Sweden and United Kingdom).

ReferenceCitation: Matejovic M, Huet O, Dams K, Elke G, Vaquerizo Alonso C, Csomos A, Krzych LJ, Tetamo R, Puthucheary Z, Rooyackers O, Tjader I, Kuechenhoff H, Hartl WH, Hiesmayr M. Medical nutrition therapy and clinical outcomes in critically ill adults: a European multinational, prospective observational cohort study (EuroPN). Crit Care. 2022 May 18;26(1):143. doi: 10.1186/s13054-022-03997-z.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repository_institution: Queen Mary University of London - Queen Mary Research Online

repositories:
PubMed Central
Research Square
irua
qmro.qmul.ac.uk

publisher_dissemination: Springer-Nature

ReferenceCitation: Hiesmayr M, Csomos A, Dams K, Elke G, Hartl W, Huet O, Krzych LJ, Kuechenhoff H, Matejovic M, Puthucheary ZA, Rooyackers O, Tetamo R, Tjader I, Vaquerizo C. Protocol for a prospective cohort study on the use of clinical nutrition and assessment of long-term clinical and functional outcomes in critically ill adult patients. Clin Nutr ESPEN. 2021 Jun;43:104-110. doi: 10.1016/j.clnesp.2021.01.048. Epub 2021 Feb 12.

evidence: open (via crossref license)

repositories_concat: irua

publisher_dissemination: Elsevier

lead_sponsor: Fresenius Kabi

sponsor_collaborators:
Fresenius Kabi
IQVIA Commercial GmbH & Co. OHG

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Sweden
Austria
Belgium
Spain
Czechia
France

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie

location_facility: Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit

location_facility: Klinikum Wetzlar-Braunfels - Klinik für Geriatrie

location_facility: Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana)

location_facility: Hospital Center University of Caen Normandie

location_facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

location_facility: Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin

location_facility: Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL)

location_facility: Hôpital Trousseau - Surgical Intensive Care Unit

location_facility: Charité Universitätsmedizin - Campus Benjamin Franklin

location_facility: III Internal Gerontometabolic Clinic, University Hospital Hradec Králové

location_facility: Hospital Universitario de Fuenlabrada - Intensive Care Unit

location_facility: UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: University of Debrecen - Department of Anaesthesiology and Intensive Therapy

location_facility: Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology

location_facility: Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon

location_facility: The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. Z o.o.

location_facility: 3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové

location_facility: Karolinska University Hospital, PMI Huddinge, B31

location_facility: University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry

location_facility: Clinic of Internal Medicine and Gastroenterology, University Hospital Brno

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Hospices Civils de Lyon - Hópital Edouard Herriot

location_facility: Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno

location_facility: Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové


summary:
Post-ERCP pancreatitis can be a serious complication to ERCP. Two studies have shown a promising preventive effect of glyceryl nitrate. This study should provide a final answer to the clinical question: Does glyceryl nitrate prevent post-ERCP pancreatitis? The study is a prospective, randomized, double blind, placebo-controlled multicenter trial. The investigators intend to include 1600 patients from Norway, Sweden, Denmark, and France.

The patients will receive either placebo or a glyceryl nitrate patch (15 mg/24 hours). Follow-up will occur after 7 days. The primary outcome measure will be post-ERCP pancreatitis, and secondary outcome measures will be mild, moderate and severe pancreatitis; post procedure pancreatitis-related mortality; and adverse events.

primary_purpose: Prevention

ReferenceCitation: Freeman ML. Post-ERCP pancreatitis: patient and technique-related risk factors. JOP. 2002 Nov;3(6):169-76. No abstract available.

ReferenceCitation: Demols A, Deviere J. New frontiers in the pharmacological prevention of post-ERCP pancreatitis: the cytokines. JOP. 2003 Jan;4(1):49-57.

ReferenceCitation: Testoni PA. Preventing post-ERCP pancreatitis: where are we? JOP. 2003 Jan;4(1):22-32.

ReferenceCitation: Mariani A. Pharmacological prevention of post-ERCP pancreatitis: which therapy is best? JOP. 2003 Jan;4(1):68-74.

ReferenceCitation: Murray B, Carter R, Imrie C, Evans S, O'Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology. 2003 Jun;124(7):1786-91. doi: 10.1016/s0016-5085(03)00384-6.

ReferenceCitation: Sand J, Nordback I. Prospective randomized trial of the effect of nifedipine on pancreatic irritation after endoscopic retrograde cholangiopancreatography. Digestion. 1993;54(2):105-11. doi: 10.1159/000201021.

ReferenceCitation: Sudhindran S, Bromwich E, Edwards PR. Prospective randomized double-blind placebo-controlled trial of glyceryl trinitrate in endoscopic retrograde cholangiopancreatography-induced pancreatitis. Br J Surg. 2001 Sep;88(9):1178-82. doi: 10.1046/j.0007-1323.2001.01842.x.

ReferenceCitation: Moreto M, Zaballa M, Casado I, Merino O, Rueda M, Ramirez K, Urcelay R, Baranda A. Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: A randomized double-blind trial. Gastrointest Endosc. 2003 Jan;57(1):1-7. doi: 10.1067/mge.2003.29.

ReferenceCitation: Harrison LI, Riedel DJ, Machacek JH, Crowley JK, Kanniainen CM, Hoglin JA, Robison TS, Zumhofe JM. Bioequivalence Comparison of Two Drug-in-Adhesive Transdermal Nitroglycerin Patches. Am J Ther. 1996 Aug;3(8):580-585. doi: 10.1097/00045391-199608000-00006.

ReferenceCitation: Pande H, Thuluvath P. Pharmacological prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Drugs. 2003;63(17):1799-812. doi: 10.2165/00003495-200363170-00003.

ReferenceCitation: Freeman ML. Prevention of post-ERCP pancreatitis: pharmacologic solution or patient selection and pancreatic stents? Gastroenterology. 2003 Jun;124(7):1977-80. doi: 10.1016/s0016-5085(03)00553-5. No abstract available.

ReferenceCitation: Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.

ReferenceCitation: Nojgaard C, Hornum M, Elkjaer M, Hjalmarsson C, Heyries L, Hauge T, Bakkevold K, Andersen PK, Matzen P; European Post-ERCP Pancreatitis Preventing Study Group. Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial. Gastrointest Endosc. 2009 May;69(6):e31-7. doi: 10.1016/j.gie.2008.11.042.

lead_sponsor: Hvidovre University Hospital

location_country: Denmark Sweden Norway France

location_facility: Dept. of Medical Gastroenterology F, KAS Gentofte

location_facility: Dept of Surgery, University Hospital Malmö

location_facility: Serv Gastroenterologie Hopital Sainte Marguerite

location_facility: Dept of Medical Gastroenterology S, Odense Universitetshospital

location_facility: Helse Fonna HF Haugesund Sjukehus Kirurgisk - vest blokk gastro

location_facility: Div of Gastroenterology, dept. of Int Medicine Affiliated Hospital University of Oslo, Østfold Fredrikstad

location_facility: Department of Medical and Surgical Gastroenterology, KAS Glostrup


title: Lymphocyte Reconstitution in a Randomized Study After Administration of Pegfilgrastim Versus Filgrastim in Patients With B-cell Non-Hodgkin Lymphoma Treated With High-dose Chemotherapy and Autologous Peripheral Stem Cell Transplantation

summary: The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral stem cell transplantation.

ReferenceCitation: Dieckmann D, Plottner H, Berchtold S, Berger T, Schuler G. Ex vivo isolation and characterization of CD4(+)CD25(+) T cells with regulatory properties from human blood. J Exp Med. 2001 Jun 4;193(11):1303-10. doi: 10.1084/jem.193.11.1303.

ReferenceCitation: Goguel AF, Crainic K, Ducailar A, Ouin M. Interlaboratory quality assessment of lymphocyte phenotyping. Etalonorme 1990-1992 surveys. Biol Cell. 1993;78(1-2):79-84. doi: 10.1016/0248-4900(93)90118-x.

ReferenceCitation: Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130.

ReferenceCitation: Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.

ReferenceCitation: Joao C, Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Markovic SN. Early lymphocyte recovery after autologous stem cell transplantation predicts superior survival in mantle-cell lymphoma. Bone Marrow Transplant. 2006 May;37(9):865-71. doi: 10.1038/sj.bmt.1705342.

ReferenceCitation: Jonuleit H, Schmitt E, Stassen M, Tuettenberg A, Knop J, Enk AH. Identification and functional characterization of human CD4(+)CD25(+) T cells with regulatory properties isolated from peripheral blood. J Exp Med. 2001 Jun 4;193(11):1285-94. doi: 10.1084/jem.193.11.1285.

ReferenceCitation: Noether, G. E. Sample size determination for some common nonparametric statistics. Journal of the American Statistical Association 82 : 645-47, 1987.

ReferenceCitation: Peggs KS. Immune reconstitution following stem cell transplantation. Leuk Lymphoma. 2004 Jun;45(6):1093-101. doi: 10.1080/10428190310001641260.

ReferenceCitation: Porrata LF, Gertz MA, Inwards DJ, Litzow MR, Lacy MQ, Tefferi A, Gastineau DA, Dispenzieri A, Ansell SM, Micallef IN, Geyer SM, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous hematopoietic stem cell transplantation in multiple myeloma or non-Hodgkin lymphoma. Blood. 2001 Aug 1;98(3):579-85. doi: 10.1182/blood.v98.3.579.

ReferenceCitation: Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Litzow MR, Winters JL, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous stem cell transplantation in non-Hodgkin lymphoma: a prospective study. Biol Blood Marrow Transplant. 2008 Jul;14(7):807-16. doi: 10.1016/j.bbmt.2008.04.013.

ReferenceCitation: Porrata LF, Inwards DJ, Micallef IN, Ansell SM, Geyer SM, Markovic SN. Early lymphocyte recovery post-autologous haematopoietic stem cell transplantation is associated with better survival in Hodgkin's disease. Br J Haematol. 2002 Jun;117(3):629-33. doi: 10.1046/j.1365-2141.2002.03478.x.

ReferenceCitation: Reimer P, Kunzmann V, Wilhelm M, Weissbrich B, Kraemer D, Berghammer H, Weissinger F. Cellular and humoral immune reconstitution after autologous peripheral blood stem cell transplantation (PBSCT). Ann Hematol. 2003 May;82(5):263-70. doi: 10.1007/s00277-003-0630-4. Epub 2003 Mar 22.

ReferenceCitation: Roberts MM, To LB, Gillis D, Mundy J, Rawling C, Ng K, Juttner CA. Immune reconstitution following peripheral blood stem cell transplantation, autologous bone marrow transplantation and allogeneic bone marrow transplantation. Bone Marrow Transplant. 1993 Nov;12(5):469-75.

ReferenceCitation: Sebban, C., Lefranc, A, Perrier, L., Morreau, P., Espinouse, D., Moles-Moreau, M-P, Kammoun, L, Ghesquieres, H, Segura-Ferlay, C., Bay, J-O, Lissandre, S, PEROL, D, Michallet, M, and Quittet, P. A Randomized Phase II Study Evaluating the Efficacy, Safety and Cost-Effectiveness of Pegfilgrastim and Filgrastim After High Dose Chemotherapy and Autologous Stem Cell Transplantation In Patients with Lymphoma and Myeloma (PALM Study). ASH . 4-12-2010. Ref Type: Abstract

ReferenceCitation: Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.

ReferenceCitation: Singh RK, Ino K, Varney ML, Heimann DG, Talmadge JE. Immunoregulatory cytokines in bone marrow and peripheral blood stem cell products. Bone Marrow Transplant. 1999 Jan;23(1):53-62. doi: 10.1038/sj.bmt.1701518.

ReferenceCitation: Talmadge JE, Reed E, Ino K, Kessinger A, Kuszynski C, Heimann D, Varney M, Jackson J, Vose JM, Bierman PJ. Rapid immunologic reconstitution following transplantation with mobilized peripheral blood stem cells as compared to bone marrow. Bone Marrow Transplant. 1997 Jan;19(2):161-72. doi: 10.1038/sj.bmt.1700626.

ReferenceCitation: Thornton AM, Shevach EM. Suppressor effector function of CD4+CD25+ immunoregulatory T cells is antigen nonspecific. J Immunol. 2000 Jan 1;164(1):183-90. doi: 10.4049/jimmunol.164.1.183.

ReferenceCitation: Vanstraelen G, Frere P, Ngirabacu MC, Willems E, Fillet G, Beguin Y. Pegfilgrastim compared with Filgrastim after autologous hematopoietic peripheral blood stem cell transplantation. Exp Hematol. 2006 Mar;34(3):382-8. doi: 10.1016/j.exphem.2005.11.013.

ReferenceCitation: Woo EY, Chu CS, Goletz TJ, Schlienger K, Yeh H, Coukos G, Rubin SC, Kaiser LR, June CH. Regulatory CD4(+)CD25(+) T cells in tumors from patients with early-stage non-small cell lung cancer and late-stage ovarian cancer. Cancer Res. 2001 Jun 15;61(12):4766-72.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Amgen

location_facility:
Centre Leon Berard
CHU Clermont-Ferrand, Hôpital d'Estaing


title: Anxiety of Patient and His Partner During Admission to Emergency Department

acronym: ANXURG

summary: Evaluate and compare the impact of partner's stress in the pain of the patient admitted in the emergency department


title: Prognostic and Predictive Impact of Circulating Tumor DNA in Advanced and Localized Gastric Cancer Treatment

acronym: PLAGAST

summary:
The evaluation of the chemotherapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. The management of treatment for gastric cancer needs the development of early biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early chemotherapy resistance. In this prospective study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.

Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of tumor response according to the tumor DNA circulating assessment in gastric cancer treatment, in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be continued uselessly, (ii) and to allow a early changing to an alternative chemotherapy regimen.

lead_sponsor: Association des Gastroentérologues Oncologues


title: Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections

acronym: RIFACute

summary:
Cutibacterium acnes is involved in nearly 40% of shoulder prosthetic joint infections (PJI). After shoulder prothesis, C. acnes mainly affects hip prosthesis. One recent work from the Lyon (France) bone and joint infections reference center with data focusing mainly on hip and knee PJI has reported that C. acnes is the leading cause of late-onset PJI after coagulase negative staphylococci (CNS) (late acute PJI not considered).

In such late-onset device-related infection, biofilm, as produced by C. acnes during PJI represents a major hurdle on the path to patient's cure. Because biofilm-associated bacteria have a slower metabolism and a lower multiplication rate than planktonic bacteria, antibiotic susceptibility can be hampered.

Rifampicin is an antibiotic with low minimal bactericidal concentration against S. aureus and CNS biofilm-associated bacteria8 which significantly influence patient's outcome during staphylococci PJI.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Not planned

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Ch Tourcoing
HCL
CHRU Tours
CHU Toulouse
CHU de NICE
CHU de Nantes
CHU de BORDEAUX
CHU de Rennes
Dianonesses croix saint simon
AP-HM
CHU de MONTPELLIER
CH Annecy Genevois


title: MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting

summary: The purpose of this study is to determine the effect of an antidepressive medication (Escitalopram), started preoperatively and given during 6 months, on 6-month and 1 year post-operative morbidity and mortality after coronary artery bypass grafting

lead_sponsor: Hopital Jean Minjoz

sponsor_collaborators:
Hopital Jean Minjoz
H. Lundbeck A/S


title: Evolution of Visual Impairment During Pseudoxanthoma Elasticum

summary:
Pseudoxanthoma elasticum is a disease whom frequency is estimated about 1/50000 to 1/100 000. There is a female preponderance with a sex-ratio of 2:1. PXE is transmitted according either to an autosomal dominant mode or to an autosomal recessive one. Mutations in the ABCC6 gene on chromosome 16p13.1 have recently been identified causing PXE. The elastic fibers slowly become mineralized mainly in the skin, the eyes, and the cardiovascular system. PXE is a multisystem disease that includes a spectrum of clinical manifestations affecting the skin, the eye or the cardiovascular system as well as other tissues. It can be responsible for severe and life threatening complications. Skin changes are usually the first manifestations and begin in early childhood. The vital prognosis of PXE depends on the severity of the cardiovascular lesions that could be responsible for sudden death in children and young adults.

Ocular manifestations are quite constant and include chorioretinal scarring, pigmentary changes or angioid streaks. The natural evolution of the angioid streaks leads to their enlargement or to the occurrence of subfoveal choroidal neovascularizations and hemorrhages leaving macular scares. A self-monitoring is recommended since early treatment of subfoveal CNV is the only way to minimize their pejorative consequences. The gold standard treatment of the CNV consists in the photocoagulation. New therapeutics has been developed including photodynamic therapy or intravitreal injection of anti-angiogenic agents and they seems to be effective to reduce the immediate complications of a limited CNV. This evolution explains that 50 to 70 % of the patients have a poor vision or legal blindness of one or both eyes. However, little is known about the age of occurrence of visual impairment in PXE patients. That is the reason why we decided to review the ophthalmologic status and visual history of our population of PXE patients according to their age.

ReferenceCitation: Pakalnis L, Makoroto J. Reproduction and the test tube baby. Can Nurse. 1977 Feb;73(2):34-8.

lead_sponsor: European Georges Pompidou Hospital


title: Randomized Prospective Multicenter Study of Non Invasive Ventilation Assessment for Weaning From Mechanical Ventilation in Patients With Chronic Respiratory Failure. NIV and Weaning (VENISE)Trial.

acronym: VENISE

summary:
The clinical efficacy of noninvasive ventilation (NIV) has now been demonstrated in the management of acute-on-chronic respiratory failure (ACRF) of various etiologies. Endotracheal mechanical ventilation (ETMV) can lead to numerous complications and weaning difficulties increasing the risk of prolonged ETMV, morbidity and mortality as well as excess cost of intensive care. Therefore, it could be interesting to use NIV for delivering effective ventilatory support and reduce the length of ETMV in ACRF patients still not capable to maintain spontaneous breathing. From the interesting but discordant results of two recent randomised controlled trial, a working group from the Société de Réanimation de Langue Française (SRLF) decided to perform a new prospective randomised controlled and multicenter trial. The aim of the study is to assess the usefulness of NIV as an extubation and weaning technique in ventilated ACRF patients. The methodology used compares three weaning strategies in parallel in ACRF patients considered difficult to wean : invasive conventional weaning (group A), extubation relayed by nasal oxygentherapy (group B), and extubation relayed by NIV (group C). Based on the main end-point defined as the weaning success/failure rate, 208 patients from17 investigator centers are planned to be included. Results of the study will also allow to assess the respective impact of the three weaning strategies on the length of ETMV and weaning, the mechanical ventilation-related morbidity, the patients lengths of stay and mortality.

Results of the VENISE trial should permit to improve the management of the difficult to wean ACRF patients and thus to contribute to more define the place of NIV among the weaning and prevention of re-intubation strategies in these patients.

ReferenceCitation: Girault C, Chajara A, Dachraoui F, Chambaretaud V, Hellot MF, Benichou J, Bonmarchand G; Groupe d'Etude VENISE. [VENISE: Non-invasive ventilation during mechanical ventilation weaning in chronic respiratory failure patients. A prospective randomised controlled and multicenter trial]. Rev Mal Respir. 2003 Dec;20(6 Pt 1):940-5. French.

ReferenceCitation: Girault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L'Her E, Hilbert G, Capellier G, Rabbat A, Besbes M, Guerin C, Guiot P, Benichou J, Bonmarchand G; VENISE Trial Group. Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir Crit Care Med. 2011 Sep 15;184(6):672-9. doi: 10.1164/rccm.201101-0035OC.

lead_sponsor: University Hospital, Rouen

location_facility: Rouen University Charles Nicolle Hospital


title: A First in Human Phase I Study of INVAC-1 as a Single Agent in Patients With Advanced Cancer

summary: INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.

ReferenceCitation: Teixeira L, Medioni J, Garibal J, Adotevi O, Doucet L, Durey MD, Ghrieb Z, Kiladjian JJ, Brizard M, Laheurte C, Wehbe M, Pliquet E, Escande M, Defrance R, Culine S, Oudard S, Wain-Hobson S, Doppler V, Huet T, Langlade-Demoyen P. A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Feb 1;26(3):588-597. doi: 10.1158/1078-0432.CCR-19-1614. Epub 2019 Sep 26.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Invectys

sponsor_collaborators:
Invectys
Keyrus Biopharma

location_facility:
Hôpital Saint Louis
Hôpital Européen Georges Pompidou

intervention_type: Biological


title: Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.

acronym: EMUPRO

summary: Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

lead_sponsor: Elsan

location_facility:
Centre clinical
Pôle Santé République
Clinique du Renaison
Polyclinique de Poitiers
Hôpital privé Océane
Clinique Esquirol Saint Hilaire
Polyclinique Montréal
Hôpital Privé Saint-François
Polyclinique de Franche Comté
Clinique Keraudren - CHPB
Clinique Claude Bernard
Polyclinique du Parc
Clinique Ambroise Paré
Clinique de Saint Augustin
Clinique Emailleurs-Colombier
Polyclinique Médipôle Saint-Roch
Clinique Saint-Augustin
Polyclinique Les Fleurs
Clinique Guillaume De Varye
Clinique de l'Estrée
Pôle Santé Sud
Clinique Cap-d'Or
Clinique Rhône Durance
Hôpital Privé La Châtaigneraie
Centre Médico-Chirurgical Les Cèdres
Clinique St Vincent
Polyclinique de Gentilly
Polyclinique de Limoges
Polyclinique Grand Sud
Polyclinique Vauban


title: Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

summary:
The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.

Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.

The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.

ReferenceCitation: Pommier P, Gomez F, Sunyach MP, D'Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004 Apr 15;22(8):1447-53. doi: 10.1200/JCO.2004.07.063.

ReferenceCitation: Perol D, Provencal J, Hardy-Bessard AC, Coeffic D, Jacquin JP, Agostini C, Bachelot T, Guastalla JP, Pivot X, Martin JP, Bajard A, Ray-Coquard I. Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial. BMC Cancer. 2012 Dec 17;12:603. doi: 10.1186/1471-2407-12-603.

sponsor_collaborators:
Centre Leon Berard
BOIRON


title: Characterising SARcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over at Risk of Mobility Disability. An OBServational Clinical Trial (SARA-OBS)

acronym: SARA-OBS

summary:
The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no therapeutic intervention that will be conducted in three European countries, (Belgium, France and Italy), and in the US.

300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.

Participants aged ≥ 65 years complaining of poor physical function will be selected to perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI < 0.789 in men and 0.512 in women will be included. The investigational phase will comprise two main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test and the 400-metre walking test will be administered at the main visits. Patient Reported Outcomes (PROs) will be completed by the patients at the same visits.

lead_sponsor: Biophytis

location_country:
United States
Italy
Belgium
France

location_facility: Centre Hospitalier Lyon Sud 165 Chemin du Grand Revoyet

location_facility: Jean Mayer USDA Human Nutrition research Center on Aging Tufts University


title: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

summary: This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.

ReferenceCitation: Rochette A, Raux O, Troncin R, Dadure C, Verdier R, Capdevila X. Clonidine prolongs spinal anesthesia in newborns: a prospective dose-ranging study. Anesth Analg. 2004 Jan;98(1):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C.

ReferenceCitation: Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7. doi: 10.1111/j.1460-9592.2005.01664.x.

lead_sponsor: University Hospital, Montpellier


title: Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections

acronym: TEDIZOAM

summary: Pilot study the aim of which is to obtain reliable data on the tolerance, compliance and efficacy of Tedizolid used as prolonged (≥ 6 weeks) monotherapy or in combination therapy for the treatment of patients with orthopedic device infections due to Gram positive cocci.

ReferenceCitation: Titecat M, Senneville E, Wallet F, Dezeque H, Migaud H, Courcol RJ, Loiez C. Microbiologic profile of Staphylococci isolated from osteoarticular infections: evolution over ten years. Surg Infect (Larchmt). 2015 Feb;16(1):77-83. doi: 10.1089/sur.2013.258. Epub 2015 Feb 4.

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Titecat M, Senneville E, Wallet F, Dezeque H, Migaud H, Courcol RJ, Loiez C. Bacterial epidemiology of osteoarticular infections in a referent center: 10-year study. Orthop Traumatol Surg Res. 2013 Oct;99(6):653-8. doi: 10.1016/j.otsr.2013.02.011. Epub 2013 Aug 27.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Pulcini C, Couadau T, Bernard E, Lorthat-Jacob A, Bauer T, Cua E, Mondain V, Chichmanian RM, Dellamonica P, Roger PM. Adverse effects of parenteral antimicrobial therapy for chronic bone infections. Eur J Clin Microbiol Infect Dis. 2008 Dec;27(12):1227-32. doi: 10.1007/s10096-008-0570-y. Epub 2008 Sep 26.

ReferenceCitation: Spellberg B, Lipsky BA. Systemic antibiotic therapy for chronic osteomyelitis in adults. Clin Infect Dis. 2012 Feb 1;54(3):393-407. doi: 10.1093/cid/cir842. Epub 2011 Dec 12.

ReferenceCitation: Morata L, Tornero E, Martinez-Pastor JC, Garcia-Ramiro S, Mensa J, Soriano A. Clinical experience with linezolid for the treatment of orthopaedic implant infections. J Antimicrob Chemother. 2014 Sep;69 Suppl 1:i47-52. doi: 10.1093/jac/dku252.

evidence: open (via free article)

ReferenceCitation: Morata L, Senneville E, Bernard L, Nguyen S, Buzele R, Druon J, Tornero E, Mensa J, Soriano A. A Retrospective Review of the Clinical Experience of Linezolid with or Without Rifampicin in Prosthetic Joint Infections Treated with Debridement and Implant Retention. Infect Dis Ther. 2014 Dec;3(2):235-43. doi: 10.1007/s40121-014-0032-z. Epub 2014 Aug 20.

license: cc-by-nc

license_normalized: cc-by-nc

license: unspecified-oa

license_normalized: unspecified-oa

ReferenceCitation: Senneville E, Legout L, Valette M, Yazdanpanah Y, Beltrand E, Caillaux M, Migaud H, Mouton Y. Effectiveness and tolerability of prolonged linezolid treatment for chronic osteomyelitis: a retrospective study. Clin Ther. 2006 Aug;28(8):1155-1163. doi: 10.1016/j.clinthera.2006.08.001.

ReferenceCitation: Senneville E, Legout L, Valette M, Yazdanpanah Y, Giraud F, Beltrand E, Obert G, Dubreuil L, Migaud H, Mouton Y. Risk factors for anaemia in patients on prolonged linezolid therapy for chronic osteomyelitis: a case-control study. J Antimicrob Chemother. 2004 Oct;54(4):798-802. doi: 10.1093/jac/dkh409. Epub 2004 Aug 25.

ReferenceCitation: Legout L, Senneville E, Gomel JJ, Yazdanpanah Y, Mouton Y. Linezolid-induced neuropathy. Clin Infect Dis. 2004 Mar 1;38(5):767-8. doi: 10.1086/381762. No abstract available.

ReferenceCitation: Legout L, Valette M, Dezeque H, Nguyen S, Lemaire X, Loiez C, Caillaux M, Beltrand E, Dubreuil L, Yazdanpanah Y, Migaud H, Senneville E. Tolerability of prolonged linezolid therapy in bone and joint infection: protective effect of rifampicin on the occurrence of anaemia? J Antimicrob Chemother. 2010 Oct;65(10):2224-30. doi: 10.1093/jac/dkq281. Epub 2010 Jul 29.

ReferenceCitation: Betriu C, Morales G, Rodriguez-Avial I, Culebras E, Gomez M, Lopez-Fabal F, Picazo JJ. Comparative activities of TR-700 (torezolid) against staphylococcal blood isolates collected in Spain. Antimicrob Agents Chemother. 2010 May;54(5):2212-5. doi: 10.1128/AAC.01653-09. Epub 2010 Feb 22.

ReferenceCitation: Douros A, Grabowski K, Stahlmann R. Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones. Expert Opin Drug Metab Toxicol. 2015;11(12):1849-59. doi: 10.1517/17425255.2015.1098617. Epub 2015 Oct 12. Erratum In: Expert Opin Drug Metab Toxicol. 2015;11(12):v.

publisher_dissemination: Informa

ReferenceCitation: Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Flanagan S, McKee EE, Das D, Tulkens PM, Hosako H, Fiedler-Kelly J, Passarell J, Radovsky A, Prokocimer P. Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function. Antimicrob Agents Chemother. 2015 Jan;59(1):178-85. doi: 10.1128/AAC.03684-14. Epub 2014 Oct 20.

ReferenceCitation: Lodise TP, Bidell MR, Flanagan SD, Zasowski EJ, Minassian SL, Prokocimer P. Characterization of the haematological profile of 21 days of tedizolid in healthy subjects. J Antimicrob Chemother. 2016 Sep;71(9):2553-8. doi: 10.1093/jac/dkw206. Epub 2016 Jun 17.

ReferenceCitation: Schmidt-Malan SM, Greenwood Quaintance KE, Karau MJ, Patel R. In vitro activity of tedizolid against staphylococci isolated from prosthetic joint infections. Diagn Microbiol Infect Dis. 2016 May;85(1):77-9. doi: 10.1016/j.diagmicrobio.2016.01.008. Epub 2016 Jan 12.

ReferenceCitation: Morata L, Mensa J, Soriano A. New antibiotics against gram-positives: present and future indications. Curr Opin Pharmacol. 2015 Oct;24:45-51. doi: 10.1016/j.coph.2015.07.004. Epub 2015 Jul 30. Erratum In: Curr Opin Pharmacol. 2015 Oct;24:147.

sponsor_collaborators:
Tourcoing Hospital
Eric SENNEVILLE M.D. Ph.D.

location_facility:
Hôpital Ambroise Paré
Hôpital de la Croix Rousse


title: Focus Sur l'Analyse de la récupération en oxymétries transcutanées (French Language)

acronym: FARO

summary: Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry

time_perspective: Cross-Sectional

ipd_sharing_description: Data available under reasonable request

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test


title: Evaluating the Effectiveness of an Integrative Intervention Based on Physical Activity, Nutrition and Supportive Care (the ADA Program) to Improve the Quality of Life of Breast Cancer Survivors: Protocol for a Pragmatic Cluster Randomized Trial and Embedded Qualitative Study

acronym: ADA

summary:
Despite it being one of the leading causes of cancer death among women, survival following a breast cancer diagnosis has greatly increased in high-income countries. However; this gave rise to a growing population of women living long after breast cancer with a diminished quality of life (QoL) due to the long-term effects of cancer and cancer treatment.

Exercise can improve QoL, fatigue, and other mental and physical health outcomes in this population, and is strongly recommended among breast cancer survivors, much like a healthy diet. However adherence in real-life to these recommendations is seldom satisfactory. Also, evidence regarding the effect and cost-effectiveness of concurrent healthy lifestyle behaviors compared to exercise alone is limited. Hence the need to develop pragmatic (evaluating the effectiveness of interventions in real-life conditions) theoretical-based customized interventions, which aim to improve uptake and instill long-term adherence of health lifestyle among breast cancer survivors.

ADA (Activité physique adaptée Doublée d'un Accompagnement spécifique post-cancer) is an integrative intervention based on physical activity, nutrition and supportive care. The interventions aims to improve breast cancer survivors' physical and mental health and instill long-term healthy behaviors.

Our study will be a pragmatic two-arm (ADA intervention versus control/usual care) cluster randomized controlled trial which examines the effectiveness of the ADA intervention program.

The primary endpoint will be health-related quality of life, as measured at 12-month after the start of the trial.

Several secondary outcomes will also be assessed; which include Physical activity level, relationship to food and self-efficacy.

The study aims to recruit 160 participants in total, divided into 20 activity groups (clusters) of 8 participants.

Primary analyses will be carried out on an intention to treat (ITT) basis, at both cluster and participant level. All statistical analysis will adjust for the clustering of patients within centers as a random effect.

The aim of this trial is to provide scientific evidence on the 'real-world' effectiveness of an easily generalizable trial, with clinically-significant outcomes, touching a growing number of cancer survivors.

lead_sponsor: Siel Bleu

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Laval
Creil
Sens
Dijon
Lille
La Roche sur Yon
Brest
Marseille
Lyon
La Rochelle


title: Pilot Study on Interferon Gamma in Association With Peg-Interferon Alpha 2a and Ribavirin Among Patients With a Chronic Hepatitis C and Non Responders to the Association of Peg-Interferon Alpha 2b or 2a and Ribavirin ANRS HC16 Gammatri

summary: Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

ReferenceCitation: Couzigou P, Perusat S, Bourliere M, Trimoulet P, Poynard T, Leroy V, Marcellin P, Foucher J, Bronowicki JP, Chene G; ANRS HC16 GAMMATRI Trial Group. Interferon-gamma with peginterferon alpha-2a and ribavirin in nonresponder patients with chronic hepatitis C (ANRS HC16 GAMMATRI). J Gastroenterol Hepatol. 2013 Feb;28(2):329-34. doi: 10.1111/jgh.12060.

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

collaborators:
InterMune
Hoffmann-La Roche

location_facility: Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie


title: Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging

acronym: FaisPLASTICITE

summary:
This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.

lead_sponsor: University Hospital, Grenoble

collaborators: Laboratoire de Psychologie et NeuroCognition


acronym: DATIPO

lead_sponsor: University Hospital, Tours

summary:
The study is a prospective, open randomized, non-inferiority trial with two parallel groups, comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure (debridement and retention, 1-stage or 2 stage exchange).

The duration of the treatment antibiotic of prosthetic joint infections is only based on experts' opinion ; this one varies from 6 weeks to several months according to the customs of the influencer.

The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.

The study concerns 410 men or women of more than 18 years include in 34 centres in France.

The duration of the study is of 4 years.

ReferenceCitation: Bernard L, Arvieux C, Brunschweiler B, Touchais S, Ansart S, Bru JP, Oziol E, Boeri C, Gras G, Druon J, Rosset P, Senneville E, Bentayeb H, Bouhour D, Le Moal G, Michon J, Aumaitre H, Forestier E, Laffosse JM, Begue T, Chirouze C, Dauchy FA, Devaud E, Martha B, Burgot D, Boutoille D, Stindel E, Dinh A, Bemer P, Giraudeau B, Issartel B, Caille A. Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection. N Engl J Med. 2021 May 27;384(21):1991-2001. doi: 10.1056/NEJMoa2020198.

publisher_dissemination: Massachusetts Medical Society

location_facility: Service des maladies infectieuses et tropicales, CHU de CAEN

location_facility: Service de Médecine Interne et de Maladies Infectieuses, CHRU de TOURS

location_facility: Service des maladies infectieuses et tropicales, CH de CLERMONT-FERRAND

location_facility: Service des maladies infectieuses et tropicales, CHU d'ANGERS

location_facility: Service des maladies infectieuses et tropicales, CHU de BESANCON

location_facility: Service de Maladies Infectieuses et de Médecine Tropicale, Hôpital Pellegrin, CHU de Bordeaux

location_facility: Service de médecine interne, CH de BEZIERS

location_facility: Service des Maladies Infectieuses et tropicales, CHU de NANCY

location_facility: Centre de vaccinations internationales et de médecine des voyages du Tonkin

location_facility: Service des Maladies Infectieuses et tropicales, CHU de MONTPELLIER

location_facility: Département de Médecine Interne et Maladies Infectieuses, hôpital privé d'Antony

location_facility: Service de médecine interne, rhumatologie, Centre Hospitalier Chalon sur Saône William Morey

location_facility: Service de pneumologie - maladies infectieuses et tropicales, CH de ST QUENTIN

location_facility: Service de médecine interne et de maladies infectieuses, CHU de BREST

location_facility: Centre de chirurgie orthopédique et de la main, CHRU de STRASBOURG

location_facility: Service de chirurgie orthopédique, CH de VERSAILLES

location_facility: Service de Maladies Infectieuses, CHU de REIMS

location_facility: Service des maladies infectieuses et tropicales - médecine interne, CH de CHAMBERY

location_facility: Service de chirurgie orthopédique et traumatologique, CH de BOURG EN BRESSE

location_facility: Service de chirurgie orthopédique et traumatologique, Polyclinique de BLOIS

location_facility: Service des maladies infectieuses et tropicales CH Saint-Jean

location_facility: Service des maldies infectieuses, CH d'ANNECY

location_facility: Service des Maladies Infectieuses, CHU de RENNES

location_facility: Unité de Traumatologie -Orthopédie septique, CHRU de LILLE

location_facility: Service de Médecine Interne et Immunologie Clinique, APHP Hôpital Antoine Béclère

location_facility: Service de Maladies Infectieuses, CH de BOURG EN BRESSE

location_facility: Service de Chirurgie Orthopédique et Traumatologique, APHP Hôpital Antoine Béclère

location_facility: Service de médecine interne, maladies infections et tropicales, CHU de POITIERS

location_facility: Service des maladies infectieuses CH Gustave Dron

location_facility: Service des maladies infectieuses et tropicales Hôtel-Dieu, CHU de Nantes

location_facility: Service de Chirurgie Orthopédique et traumatologie, hôpital Trousseau

location_facility: Service de chirurgie orthopédique et traumatologique, CHU d'AMIENS

location_facility: Service de Maladies Infectieuses, CHU de LIMOGES

location_facility: Service de Chirurgie orthopédique Hôpital Lariboisière

title: Multicentric Study, of Non Inferiority, Randomized, Opened, to Evaluate the Two Durations Effectiveness of Antibiotherapy (6 Weeks Versus 12 Weeks) in the Treatment of Osteo-articular Prostheses Infections, With Prosthetic Change (in 1 Time or 2 Long Times) or Not (Articular Washing)

type: EudraCT Number

source: euctr


title: Efficacy of Varenicline Associated With Intensive Counselling Versus Placebo of Varenicline Associated With Intensive Counselling on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD). A Multicenter Randomized Double-blind Trial

acronym: SAVE

summary: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain active smokers. Brittany is the second region of France facing an abnormal high death rate related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the evolution of the disease, the frequency of the exacerbations and the the mortality. Besides, smoking cessation is associated with a reduced risk of cardiovascular events and cancer. Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such population. Furthermore, smoking cessation has been underestimated in several studies. Most of these studies evaluated various methods of smoking cessation in COPD patients performed after an exacerbation, which has a hospitalization related mortality of approximately 10%. Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is reported to be one of the most effective pharmacotherapies for smoking cessation. However, it has never been evaluated at the acute phase of an exacerbation of COPD requiring hospitalization.

ReferenceCitation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

repository_institution: Coventry University - Pure

repository_normalized: Pure (Denmark)

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

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

repositories:
PubMed Central
Pure (Denmark)
ora.ox.ac.uk

ReferenceCitation: Le Mao R, Tromeur C, Paleiron N, Sanchez O, Gagnadoux F, Jouneau S, Magnan A, Hayem-Vannimenus C, Dansou A, Proust A, Dion A, Larhantec G, Brestec AL, Dewitte JD, Roche N, Leroyer C, Couturaud F. Effect of Early Initiation of Varenicline on Smoking Cessation in COPD Patients Admitted for Exacerbation: The Save Randomized Clinical Trial. COPD. 2020 Feb;17(1):7-14. doi: 10.1080/15412555.2019.1703928. Epub 2019 Dec 19.

lead_sponsor: University Hospital, Brest

location_facility:
Laennec Hospital
Hôpital HIA Clermont Tonnerre
Hotel Dieu Hospital
Cornouaille Hospital
Bretonneau Hospital
Cavale Blanche Hospital
HEGP Hospital
Pontchaillou
CHRU Lille
Caremeau Hospital
Saint Brieuc Hospital
CHU Angers
Poitiers Hospital


title: Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the Treatment of Septic Shock

acronym: THANE

summary:
The purpose of this study is :

- to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart rate of 10% or 20%.

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Baxter Healthcare Corporation


title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)

acronym: SiMaT-B

summary:
Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10 daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients.

Hypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the average number of move to achieve tasks of the Tower of London, than those receiving sham rTMS.

ReferenceCitation: Cailhol L, Roussignol B, Klein R, Bousquet B, Simonetta-Moreau M, Schmitt L, Thalamas C, Tap G, Birmes P. Borderline personality disorder and rTMS: a pilot trial. Psychiatry Res. 2014 Apr 30;216(1):155-7. doi: 10.1016/j.psychres.2014.01.030. Epub 2014 Jan 30.

lead_sponsor: University Hospital, Toulouse