title: Mechanisms of Very Late Bioresorbable Scaffold Thrombosis Assessed by Optical Coherence Tomography: Insights From the International INVEST Registry

acronym: INVEST

summary:
Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE mark) and is used in daily clinical practice. While recent randomized controlled trials comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable device thrombosis after BVS implantation, the causes underlying thrombotic events occurring beyond one year after scaffold implantation remain unclear and require investigation in an independent manner.

The INVEST registry is a world-wide, multi-center, observational, retrospective, investigator-initiated registry, which will include any patients who suffered from very late (>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of thrombosis and provided informed consent for the further use of their health related data for this registry.

time_perspective: Cross-Sectional

ReferenceCitation: Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrié D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iñiguez A, Sabaté M, Windecker S, Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016 Nov 19;388(10059):2479-2491. doi: 10.1016/S0140-6736(16)32050-5. Epub 2016 Oct 30. Erratum in: Lancet. 2017 Feb 25;389(10071):804.

ReferenceCitation: Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.

ReferenceCitation: Onuma Y, Sotomi Y, Shiomi H, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Igarashi K, Kozuma K, Tanabe K, Kusano H, Rapoza R, Popma JJ, Stone GW, Simonton C, Serruys PW, Kimura T. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016 Oct 20;12(9):1090-1101. doi: 10.4244/EIJY16M09_01.

ReferenceCitation: Räber L, Brugaletta S, Yamaji K, O'Sullivan CJ, Otsuki S, Koppara T, Taniwaki M, Onuma Y, Freixa X, Eberli FR, Serruys PW, Joner M, Sabaté M, Windecker S. Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings. J Am Coll Cardiol. 2015 Oct 27;66(17):1901-14. doi: 10.1016/j.jacc.2015.08.853.

ReferenceCitation: de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es GA. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study). Eur Heart J. 1998 Aug;19(8):1214-23.

ReferenceCitation: Taniwaki M, Radu MD, Zaugg S, Amabile N, Garcia-Garcia HM, Yamaji K, Jørgensen E, Kelbæk H, Pilgrim T, Caussin C, Zanchin T, Veugeois A, Abildgaard U, Jüni P, Cook S, Koskinas KC, Windecker S, Räber L. Mechanisms of Very Late Drug-Eluting Stent Thrombosis Assessed by Optical Coherence Tomography. Circulation. 2016 Feb 16;133(7):650-60. doi: 10.1161/CIRCULATIONAHA.115.019071. Epub 2016 Jan 13.

ReferenceCitation: Yamaji K, Ueki Y, Souteyrand G, Daemen J, Wiebe J, Nef H, Adriaenssens T, Loh JP, Lattuca B, Wykrzykowska JJ, Gomez-Lara J, Timmers L, Motreff P, Hoppmann P, Abdel-Wahab M, Byrne RA, Meincke F, Boeder N, Honton B, O'Sullivan CJ, Ielasi A, Delarche N, Christ G, Lee JKT, Lee M, Amabile N, Karagiannis A, Windecker S, Räber L. Mechanisms of Very Late Bioresorbable Scaffold Thrombosis: The INVEST Registry. J Am Coll Cardiol. 2017 Nov 7;70(19):2330-2344. doi: 10.1016/j.jacc.2017.09.014.

lead_sponsor: University Hospital Inselspital, Berne

location_country:
Hong Kong
Spain
Italy
Austria
Netherlands
Switzerland
France
Singapore
Belgium
Germany

location_facility: Department of Cardiology, Asklepios Klinik St. Georg

location_facility: Cardiac Department, National University Heart Centre

location_facility: Department of Cardiology, CH F Mitterand, Pau Université Cedex, France.

location_facility: Department of Cardiology, University of Giessen

location_facility: Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel

location_facility: Department of Cardiology, University Hospital Leuven

location_facility: 5th Medical Department with Cardiology, Kaiser Franz Josef Hospital

location_facility: Academic Medical Center, University of Amsterdam

location_facility: Department of Cardiology, University Medical Centre Utrecht

location_facility: Department of Cardiovascular Medicine, Hypertension and Heart Failure Unit, Health Innovation Lab (Hi-Lab) Clinique Pasteur

location_facility: Cardiology Division, Department of Medicine, Pamela Youde Nethersole Eastern Hospital

location_facility: Cardiology Department, CHU Clermont-Ferrand

location_facility: Department of Cardiology, University Hospital Caremeau

location_facility: Deutsches Herzzentrum München, Technische Universität München,

location_facility: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

location_facility: Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge, Universitat de Barcelona, L' Hospitalet de Llobregat, Spain.

location_facility: Department of Cardiology, Stadtspital Triemli

location_facility: Cardiology Division, Department of Medicine, Queen Elizabeth Hospital


title: Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study

summary: This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Such P, Bøg M, Kabra MS, Jørgensen KT, de Jong-Laird AC. A Noninterventional Cohort Study Assessing Time to All-Cause Treatment Discontinuation After Initiation of Aripiprazole Once Monthly or Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-Onset Schizophrenia. Prim Care Companion CNS Disord. 2021 Sep 30;23(5). pii: 20m02886. doi: 10.4088/PCC.20m02886.

ipd_sharing: No

lead_sponsor: Otsuka Pharmaceutical Europe Ltd

location_country: Germany France Spain Italy

location_facility: Cura Neuropsichiatria Villa Von Siebenthal

location_facility: Centre Hospitalier Gillaume regnier-CHGR

location_facility: Unit Mental Health District Nº72- ASL Salerno

location_facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Unita Operativa- Salute Mentale di Salerno

location_facility: P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura

location_facility: Dipartimento di Salute Mentale -ASL Modena

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Mental Health Department (MDSM) ASP di Messina

location_facility: Ospedale Madonna del Soccorso San Bendedetto del Tronto

location_facility: Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria

location_facility: Dipartimento di Salute Mentale- ASL Napoli

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: IINA (Instituto Internacional de Neurociencias Aplicadas)

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

title: Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study

acronym: REA-LBA

summary:
Little is known about bronchoalveolar lavages performed for cytological assessment during bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual contribution to diagnosis and therapeutic decision, and complications have not been extensively assessed.

The primary objective of this multi center, prospective, observational study is to describe the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill patients, identify their indications, assess their contribution to diagnosis and therapeutic decisions, and estimate the frequency of induced respiratory events.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHD de VENDEE
CH de MONTAUBAN
CH d'ANGOULEME
CHU de DIJON
CHU d'ANGERS
CHR d'ORLEANS
CHU de STRASBOURG
CH de LA ROCHELLE
Hôpital Nord de Marseille
CHRU de POITIERS
CHU de STRASBOURG NHC
Hôpital RAYMOND POINCARE
Hopital de La Timone
CHRU de NANTES
CHRU de TOURS
CH Victor DUPOUY

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.

acronym: Restorelle

summary: Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. [Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. Review. French.

ReferenceCitation: Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5. Review.

ReferenceCitation: Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6.

ReferenceCitation: Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

ReferenceCitation: Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.

ReferenceCitation: Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. Review. French.

ReferenceCitation: Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2:CD012079. doi: 10.1002/14651858.CD012079. Review.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)

summary: This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks

study_type: Interventional

primary_purpose: Treatment

ReferenceCitation: Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.

lead_sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

location_facility:
Hôpitaux Universitaires
Hôpital Manchester
Hôpital Foch
GH Pitié Salpetriere
Hôpital Jean Minjoz
CHU Bichat
CHU
CHU Ambroise Paré
CHR de Metz
Hôpital Tenon
Hôpital Saint-André
CHU de Reims
Hôpital Croix Rousse
CHU Dijon
Hôpital de Tourcoing
Hôpital Saint-Antoine

intervention_type: Drug


title: Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic

acronym: KOALA-IS

summary: This is an observational, prospective, multicenter, cohort study in patients with cardioembolic stroke and previous oral or parenteral anticoagulant therapy. Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted, in terms of stroke or systemic embolism and haemorrhagic transformation.

status: Recruiting

lead_sponsor: Instituto de Investigación Hospital Universitario La Paz

location_country: France Spain

location_facility: Jimenez Diaz Fundation University Hospital

intervention_type: Other

status_simplified: Ongoing


title: Clinical Evaluation of the Accuracy of AMR-DetecTool for the Diagnostic of Infections With Multi Drug Resistant (MDR) Bacteria

acronym: AMR DetecTool

summary:
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. The failure to stop the spread of antimicrobial resistance (AMR) is due to a lack of fast detection methods and proper strategies.

Novel, rapid and reliable detection and characterization tests are an urgent need for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner.

AMR-DetecTool or NG Detectool is a detection system for the direct detection of AMR in clinical samples. The clinical sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown.

It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Hungary France Spain

location_facility: Hospital Clínic School of Medicine, University of Barcelona

intervention_type: Diagnostic Test


title: Biological and Clinical Database for Pancreatic Adenocarcinoma

acronym: BACAP

summary:
BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA and RNA from tumors cells.

The mission of this prospective project is to make available to the scientific community a clinical biological base from patients with pancreatic adenocarcinoma

ReferenceCitation: Maulat C, Canivet C, Touraine C, Gourgou S, Napoleon B, Palazzo L, Flori N, Piessen G, Guibert P, Truant S, Assenat E, Buscail L, Bournet B, Muscari F, The Bacap Consortium. A New Score to Predict the Resectability of Pancreatic Adenocarcinoma: The BACAP Score. Cancers (Basel). 2020 Mar 25;12(4). pii: E783. doi: 10.3390/cancers12040783.

ReferenceCitation: Frere C, Bournet B, Gourgou S, Fraisse J, Canivet C, Connors JM, Buscail L, Farge D; BACAP Consortium. Incidence of Venous Thromboembolism in Patients With Newly Diagnosed Pancreatic Cancer and Factors Associated With Outcomes. Gastroenterology. 2020 Apr;158(5):1346-1358.e4. doi: 10.1053/j.gastro.2019.12.009. Epub 2019 Dec 14.

ReferenceCitation: Canivet C, Gourgou-Bourgade S, Napoléon B, Palazzo L, Flori N, Guibert P, Piessen G, Farges-Bancel D, Seitz JF, Assenat E, Vendrely V, Truant S, Vanbiervliet G, Berthelémy P, Garcia S, Gomez-Brouchet A, Buscail L, Bournet B; BACAP Consortium. A prospective clinical and biological database for pancreatic adenocarcinoma: the BACAP cohort. BMC Cancer. 2018 Oct 16;18(1):986. doi: 10.1186/s12885-018-4906-4.

lead_sponsor: University Hospital, Toulouse

location_facility: Institut Regional du Cancer de Montpellier


title: DIFFICULT PERIPHERAL INTRAVENOUS ACCESS IN ADULT DURING THE PREOPERATIVE PERIOD

acronym: VENSCORE

summary:
The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period.

The main objective: the outcome of interest is defined as failure of cannulation on first attempt.

The risk factors of failure of cannulation on first attempt will be described. Adjusted multivariate models will be constructed. A prediction model will be proposed according to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital d'instruction des Armées Robert Picqué

location_facility: Centre hospitalier Universitaire de Bordeaux


title: Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty

acronym: miniNO

summary: Case-control study of inhaled Nitric Oxide (iNO) treatment of full-term and preterm infants. The main objective of this study is to investigate the association between premature birth and its later comorbidities (neuroendocrine, metabolic, cognitive, etc) with iNO treatment and the maturation of the HPG axis during minipuberty.

lead_sponsor: National and Kapodistrian University of Athens

location_country: France Switzerland Greece

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Regional Et Universitaire de Lille


title: Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema

acronym: TRIOZ

summary:
Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label.

In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema.

design_allocation: Randomized

ReferenceCitation: Couret C, Poinas A, Volteau C, Riche VP, Le Lez ML, Errera MH, Creuzot-Garcher C, Baillif S, Kodjikian L, Ivan C, Le Jumeau de Kergaradec LM, Chiffoleau A, Jobert A, Jaulin J, Biron L, Hervouet E, Weber M. Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial. Trials. 2020 Feb 10;21(1):159. doi: 10.1186/s13063-020-4066-0.

lead_sponsor: Nantes University Hospital

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis

acronym: ACTIVE

summary:
PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare the efficacy and safety of early administration of the combination therapy with infliximab and azathioprine with steroids and azathioprine in patients with acute severe ulcerative colitis treated with intravenous steroids.

STUDY TREATMENTS : All patients :

Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days.

Combination therapy arm:

Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day.

Azathioprine arm:

Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Hopital Louis Mourrier
Chu Besancon
CHU de CLERMONT FERRAND- Hopital Estain
Hopital Saint Joseph
Hopital St Antoine
Henri Mondor Hospital
Chu Saint Etienne
CHU NANCY - Hopital Brabois
Chu Rouen
CHU de NICE- Hopital Archet 2
CHU RENNES - Hopital Pontchaillou
APHP- Hopital BEAUJON
Hopital Saint Louis
Chu Montpellier
Chu Kremlin Bicetre
CHRU Lille


type: EudraCT Number

title: Assessment of the Clinical Value of a Docetaxel, Cisplatin and 5-fluorouracil (DCF) Strategy Adapted to Patients for the Management of Metastatic or Locally Advanced Anal Resistant Radiochemotherapy Squamous Cell Anal Carcinoma.

summary:
Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and 5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure (including salvage surgery), cisplatin-5FU combination is the standard option but complete response is a rare event and the prognosis remains poor with most patients' death occurring in the first 12 months. Decision making for physicians in this setting is only based on retrospective studies or small phase II clinical trials including less than 20 patients. Hence, no efficient standard of care is currently available for relapsing SCCA patients who are currently treated with a palliative intent.

Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved a complete response. Three patients underwent surgery of all involved metastatic sites. A pathological complete response was observed for all of them including in metastases occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the potential restoration of cancer immunosurveillance by this regimen.

Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of taxane-based chemotherapy in SCCA patients.

ReferenceCitation: Kim S, Jary M, Mansi L, Benzidane B, Cazorla A, Demarchi M, Nguyen T, Kaliski A, Delabrousse E, Bonnetain F, Letondal P, Bosset JF, Valmary-Degano S, Borg C. DCF (docetaxel, cisplatin and 5-fluorouracil) chemotherapy is a promising treatment for recurrent advanced squamous cell anal carcinoma. Ann Oncol. 2013 Dec;24(12):3045-50. doi: 10.1093/annonc/mdt396. Epub 2013 Oct 10.

ReferenceCitation: Kim S, Meurisse A, Spehner L, Stouvenot M, François E, Buecher B, André T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

ReferenceCitation: Spehner L, Kim S, Vienot A, François E, Buecher B, Adotevi O, Vernerey D, Abdeljaoued S, Meurisse A, Borg C. Anti-Telomerase CD4(+) Th1 Immunity and Monocytic-Myeloid-Derived-Suppressor Cells Are Associated with Long-Term Efficacy Achieved by Docetaxel, Cisplatin, and 5-Fluorouracil (DCF) in Advanced Anal Squamous Cell Carcinoma: Translational Study of Epitopes-HPV01 and 02 Trials. Int J Mol Sci. 2020 Sep 17;21(18). pii: E6838. doi: 10.3390/ijms21186838.

ReferenceCitation: Stouvenot M, Meurisse A, Saint A, Buecher B, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Smith D, Ghiringhelli F, Parzy A, de la Fouchardiere C, Almotlak H, Vienot A, Jacquin M, Taieb J, Nguyen T, Vernerey D, Borg C, Kim S. Second-line treatment after docetaxel, cisplatin and 5-fluorouracil in metastatic squamous cell carcinomas of the anus. Pooled analysis of prospective Epitopes-HPV01 and Epitopes-HPV02 studies. Eur J Cancer. 2022 Feb;162:138-147. doi: 10.1016/j.ejca.2021.11.019. Epub 2022 Jan 4.

ReferenceType: result

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

ReferenceCitation: Kim S, Jary M, André T, Vendrely V, Buecher B, François E, Bidard FC, Dumont S, Samalin E, Peiffert D, Pernot S, Baba-Hamed N, El Hajbi F, Bouché O, Desrame J, Parzy A, Zoubir M, Louvet C, Bachet JB, Nguyen T, Abdelghani MB, Smith D, De La Fouchardière C, Aparicio T, Bennouna J, Gornet JM, Jacquin M, Bonnetain F, Borg C. Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD groups (Epitopes-HPV02 study). BMC Cancer. 2017 Aug 25;17(1):574. doi: 10.1186/s12885-017-3566-0.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Jean Mermoz Private Hospital
Hospital of Belfort-Montbeliard
European Georges Pompidou Hospital
Saint-Antoine Hospital
Curie Institute
Antoine Lacassagne Center
University Robert Debré Hospital
FNLCC center Georges François Leclerc
Pitié Salpétrière Hospital
Paris Saint-Joseph Hospital Group
Institute of Cancerology of Lorraine
Paul Strauss Center
Mutualist Montsouris Institute
Oscar Lambret center
Regional Institute of Cancer
University hospital of Besançon


title: Evaluation of the Daily Intake of 0.5 L of Water Saturated With Molecular Hydrogen for 21 Days in COVID-19 Patients Treated in Ambulatory Care. Double-blind, Randomized, Comparative Study

acronym: HYDRO COVID

summary:
Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19.

This hypothesis is supported by numerous preclinical and theoretical arguments, as well as by some Chinese clinical studies (the Chinese guidelines for the management of Covid-19 recommend the inhalation of hydrogen), a recommendation whose interest has just been confirmed by a publication describing the very positive results of a clinical study in China.

Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19.

The ingestion of water saturated with molecular hydrogen has been the subject of several clinical studies in other indications than Covid-19, and no side effects of this ingestion have been reported. A recent publication recommends initiating clinical trials using a hydrogen fortified beverage.

status: Active, not recruiting

primary_purpose: Prevention

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16.

ReferenceCitation: Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. Review.

ReferenceCitation: TY - JOUR AU - Russell, Grace AU - Veal, David AU - Rehman, Mubasher AU - Adukwu, Emmanuel AU - LeBaron, Tyler AU - Hancock, John PY - 2020/06/22 SP - T1 - An Overview of SARS-CoV-2 (COVID-19) Infection and the Importance of Molecular Hydrogen as an Adjunctive Therapy DO - 10.20455/ros.2020.829 JO - Reactive Oxygen Species ER -

ReferenceCitation: Dole M, Wilson FR, Fife WP. Hyperbaric hydrogen therapy: a possible treatment for cancer. Science. 1975 Oct 10;190(4210):152-4.

ReferenceCitation: Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. Epub 2007 May 7.

ReferenceCitation: Itoh T, Hamada N, Terazawa R, Ito M, Ohno K, Ichihara M, Nozawa Y, Ito M. Molecular hydrogen inhibits lipopolysaccharide/interferon γ-induced nitric oxide production through modulation of signal transduction in macrophages. Biochem Biophys Res Commun. 2011 Jul 22;411(1):143-9. doi: 10.1016/j.bbrc.2011.06.116. Epub 2011 Jun 23.

ReferenceCitation: Manaenko A, Lekic T, Ma Q, Zhang JH, Tang J. Hydrogen inhalation ameliorated mast cell-mediated brain injury after intracerebral hemorrhage in mice. Crit Care Med. 2013 May;41(5):1266-75. doi: 10.1097/CCM.0b013e31827711c9.

ReferenceCitation: Xie K, Yu Y, Zhang Z, Liu W, Pei Y, Xiong L, Hou L, Wang G. Hydrogen gas improves survival rate and organ damage in zymosan-induced generalized inflammation model. Shock. 2010 Nov;34(5):495-501. doi: 10.1097/SHK.0b013e3181def9aa.

ReferenceCitation: Xie K, Fu W, Xing W, Li A, Chen H, Han H, Yu Y, Wang G. Combination therapy with molecular hydrogen and hyperoxia in a murine model of polymicrobial sepsis. Shock. 2012 Dec;38(6):656-63. doi: 10.1097/SHK.0b013e3182758646.

ReferenceCitation: Xie K, Yu Y, Huang Y, Zheng L, Li J, Chen H, Han H, Hou L, Gong G, Wang G. Molecular hydrogen ameliorates lipopolysaccharide-induced acute lung injury in mice through reducing inflammation and apoptosis. Shock. 2012 May;37(5):548-55. doi: 10.1097/SHK.0b013e31824ddc81.

ReferenceCitation: LeBaron TW, Kura B, Kalocayova B, Tribulova N, Slezak J. A New Approach for the Prevention and Treatment of Cardiovascular Disorders. Molecular Hydrogen Significantly Reduces the Effects of Oxidative Stress. Molecules. 2019 May 31;24(11). pii: E2076. doi: 10.3390/molecules24112076. Review.

ReferenceCitation: Ohta S. Molecular hydrogen as a preventive and therapeutic medical gas: initiation, development and potential of hydrogen medicine. Pharmacol Ther. 2014 Oct;144(1):1-11. doi: 10.1016/j.pharmthera.2014.04.006. Epub 2014 Apr 24. Review.

ReferenceCitation: Ono H, Nishijima Y, Adachi N, Sakamoto M, Kudo Y, Kaneko K, Nakao A, Imaoka T. A basic study on molecular hydrogen (H2) inhalation in acute cerebral ischemia patients for safety check with physiological parameters and measurement of blood H2 level. Med Gas Res. 2012 Aug 23;2(1):21. doi: 10.1186/2045-9912-2-21.

ReferenceCitation: Abraini JH, Gardette-Chauffour MC, Martinez E, Rostain JC, Lemaire C. Psychophysiological reactions in humans during an open sea dive to 500 m with a hydrogen-helium-oxygen mixture. J Appl Physiol (1985). 1994 Mar;76(3):1113-8.

ReferenceCitation: Fontanari P, Badier M, Guillot C, Tomei C, Burnet H, Gardette B, Jammes Y. Changes in maximal performance of inspiratory and skeletal muscles during and after the 7.1-MPa Hydra 10 record human dive. Eur J Appl Physiol. 2000 Mar;81(4):325-8.

ReferenceCitation: Zhou ZQ, Zhong CH, Su ZQ, Li XY, Chen Y, Chen XB, Tang CL, Zhou LQ, Li SY. Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis. Respiration. 2019;97(1):42-51. doi: 10.1159/000492031. Epub 2018 Sep 18.

ReferenceCitation: Hu Y, Sun J, Dai Z, Deng H, Li X, Huang Q, Wu Y, Sun L, Xu Y. Prevalence and severity of corona virus disease 2019 (COVID-19): A systematic review and meta-analysis. J Clin Virol. 2020 Jun;127:104371. doi: 10.1016/j.jcv.2020.104371. Epub 2020 Apr 14.

ReferenceCitation: Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, Cuomo-Dannenburg G, Thompson H, Walker PGT, Fu H, Dighe A, Griffin JT, Baguelin M, Bhatia S, Boonyasiri A, Cori A, Cucunubá Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon D, Nedjati-Gilani G, Riley S, van Elsland S, Volz E, Wang H, Wang Y, Xi X, Donnelly CA, Ghani AC, Ferguson NM. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020 Jun;20(6):669-677. doi: 10.1016/S1473-3099(20)30243-7. Epub 2020 Mar 30. Erratum in: Lancet Infect Dis. 2020 Apr 15;:. Lancet Infect Dis. 2020 May 4;:.

ReferenceCitation: Chow SC, Shao J, Wang H. A note on sample size calculation for mean comparisons based on noncentral t-statistics. J Biopharm Stat. 2002 Nov;12(4):441-56.

ReferenceCitation: LeBaron, T. W., McCullough M. L. and Ruppman Sr K. H., A novel functional beverage for COVID-19 and other conditions: Hypothesis and preliminary data, increased blood flow, and wound healing, Journal of Translational Science, 6(2020), pp 1-6, doi: 10.15761/JTS.1000380

ReferenceCitation: Guan WJ, Wei CH, Chen AL, Sun XC, Guo GY, Zou X, Shi JD, Lai PZ, Zheng ZG, Zhong NS. Hydrogen/oxygen mixed gas inhalation improves disease severity and dyspnea in patients with Coronavirus disease 2019 in a recent multicenter, open-label clinical trial. J Thorac Dis. 2020 Jun;12(6):3448-3452. doi: 10.21037/jtd-2020-057. Erratum in: J Thorac Dis. 2020 Aug;12(8):4591-4592.

ReferenceCitation: Haute Autorité de Santé. Réponses rapides dans le cadre de la Covid-19 - Prise en charge de premier recours des patients suspectés de Covid-19. Paris,18 juin 2020. Mise à jour en nov. 2020

lead_sponsor: AGIR à Dom

location_country: Morocco France Serbia

location_facility:
Timc-Imag (Umr5525 Uga-Cnrs)
Casablanca center
Public Health Center

intervention_type: Dietary Supplement


acronym: Not applicable

title: A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial

lead_sponsor: LEO Pharma

source: euctr

location_country:
Germany
France
United Kingdom

location_facility: Hôpital de la Timone - Service de Dermatologie Vénérologie

location_facility: Hôpital Saint Louis - Service de Dermatologie

location_facility: HOPITAL AVICENNE - Service de Dermatologie

location_facility: CHU de Nantes - Hôtel Dieu - Unité Fonctionnelle de Dermatologie Cancérologie

location_facility: HOPITAL COCHIN TARNIER - Service de Dermatologie

location_facility: Klinik für Dermatologie und Allergologie, Klinikum Vest, Behandlungszentrum, Knappschaftskrankenhaus Recklinghausen,

location_facility: Hôpital Claude Huriez - CHRU de Lille - Clinique de Dermatologie

location_facility: HOPITAL DE L ARCHET II - Service de Dermatologie-Vénérologie

location_facility: CHRU de Brest - Hôpital Morvan - Service de Dermatologie

location_facility: Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Hôpital d'instruction des Armées Bégin - Clinique Dermatologique

location_facility: Hauttumorzentrum Bochum Universitätsklinikum der Ruhr-Universität-Bochum

location_facility: CHU Albert Michallon - Service de Dermatologie, Pôle Pluridisciplinaire de Médecine

location_facility: Dermatologisches Zentrum, Am Krankenhaus 1

summary: The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment


title: Phase IIIb Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids.

summary:
This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid.

Principal objective is to compare the clinical effects (success/failure) of two methods of methadone titration in patients with cancer-related pain inadequately relieved or with intolerable side effects after treatment with level 3 opioid.

Secondary objectives are : Overall safety of methadone during the study, to describe the patients' characteristics, to describe the effects of methadone on pain relief, to describe the methadone administration, to evaluate patient's quality of life, to evaluate the prescriber's opinion regarding the handling of methadone initiation.

lead_sponsor: Laboratoires Bouchara-Recordati

location_facility:
Investigational Site 10
Investigational Site 13
Investigational Site 11
Investigational Site 06
Investigational Site 02
Investigational site 08
Investigational Site 12
Investigational Site 17
Investigational Site 04
Investigational Site 15
Investigational Site 03
Investigational Site 14
Investigational Site 05
Investigational Site 01
Investigational Site 07
Investigational Site 16


title: Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study

summary: This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

lead_sponsor: VISUfarma SpA

location_country: France Spain Italy

location_facility: ASST-Santi Paolo e Carlo-Presidio San Paolo

intervention_type: Device


title: Analysis of Psychosocial Determinants of Observance of Monitoring Neuro-urological in Spina-bifida Adult Patients and in Spinal Cord Injury Patients: a Prospective, Comparative, Multicenter With Parallel Groups Study

acronym: ESTIME

summary:
With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder.

The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.

status: Terminated

lead_sponsor: Rennes University Hospital

location_facility: Urologie CH Lyon Sud et Hôpital Henry Gabrielle

location_facility: Neuro-urologie et explorations périnéales, APHP Tenon

location_facility: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE

location_facility: APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale


title: Phase II Study on TSR-042 in Advanced Clear Cell Sarcoma

acronym: ACCeSs

summary: Phase II,single arm study designed to explore the activity of TSR-042, an immunotherapy agent, in patients with a diagnosis of advanced or metastatic clear cell sarcoma (CCS).

ReferenceCitation: Granter SR, Weilbaecher KN, Quigley C, Fletcher CD, Fisher DE. Clear cell sarcoma shows immunoreactivity for microphthalmia transcription factor: further evidence for melanocytic differentiation. Mod Pathol. 2001 Jan;14(1):6-9.

ReferenceCitation: Antonescu CR, Tschernyavsky SJ, Woodruff JM, Jungbluth AA, Brennan MF, Ladanyi M. Molecular diagnosis of clear cell sarcoma: detection of EWS-ATF1 and MITF-M transcripts and histopathological and ultrastructural analysis of 12 cases. J Mol Diagn. 2002 Feb;4(1):44-52.

ReferenceCitation: Stacchiotti S, Grosso F, Negri T, Palassini E, Morosi C, Pilotti S, Gronchi A, Casali PG. Tumor response to sunitinib malate observed in clear-cell sarcoma. Ann Oncol. 2010 May;21(5):1130-1. doi: 10.1093/annonc/mdp611. Epub 2010 Jan 21.

ReferenceCitation: Tazzari M, Palassini E, Vergani B, Villa A, Rini F, Negri T, Colombo C, Crippa F, Morosi C, Casali PG, Pilotti S, Stacchiotti S, Rivoltini L, Castelli C. Melan-A/MART-1 immunity in a EWS-ATF1 translocated clear cell sarcoma patient treated with sunitinib: a case report. BMC Cancer. 2015 Feb 14;15:58. doi: 10.1186/s12885-015-1044-0.

lead_sponsor: Italian Sarcoma Group

location_facility: Fondazione IRCSS Istituto Nazionale dei Tumori


title: Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival

summary:
This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up.

This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer.

The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line.

This score will then be validated on the 2nd cohort.

There will be no interruption of inclusions between first and second cohort of patients

primary_purpose: Other

lead_sponsor: Institut Claudius Regaud

location_facility: Centre d'Oncologie et de Radiothérapie du Parc

location_facility: Institut de Cancérologie de l'Ouest Paul Papin

location_facility: Centre Hospitalier Intercommunal de Castres-Mazamet


title: A Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD)

acronym: SUNRISE-PD

summary: This study consists of two parts. Part A will evaluate the safety and tolerability of multiple doses of OXB-102 (AXO-Lenti-PD) in participants with Parkinson's disease. Part B will assess the safety and efficacy of the selected dose of OXB-102 in participants with Parkinson's disease.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS: 1. GENE THERAPY FOR PARKINSON'S, 2. PHASE 3 STUDY IN FOCUS - INTEC PHARMA'S ACCORDION PILL, 3. CLINICAL TRIALS RESOURCES. J Parkinsons Dis. 2019;9(2):251-264. doi: 10.3233/JPD-199001.

lead_sponsor: Sio Gene Therapies

location_country:
France
United Kingdom

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: University of Cambridge, Centre for Brain Repair

location_facility: Service de Neurochirurgie, Hôpital Henri Mondor


title: An Exploratory Study of Brain Imaging Biomarkers in Patients With Alzheimer's Pathology Receiving Standard of Care

summary: This study will investigate the volume, function and composition of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning technology in participants with memory complaints or early signs of Alzheimer's pathology.

primary_purpose: Basic Science

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


ipd_sharing: Yes

title: An Open Label, Single Arm, Multiple Dose Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of LNP023 When Administered in Addition to Standard of Care (SoC) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active Hemolysis

lead_sponsor: Novartis Pharmaceuticals

design_allocation: Non-Randomized

ReferenceCitation: Risitano AM, Röth A, Soret J, Frieri C, de Fontbrune FS, Marano L, Alashkar F, Benajiba L, Marotta S, Rozenberg I, Milojevic J, End P, Nidamarthy PK, Junge G, Peffault de Latour R. Addition of iptacopan, an oral factor B inhibitor, to eculizumab in patients with paroxysmal nocturnal haemoglobinuria and active haemolysis: an open-label, single-arm, phase 2, proof-of-concept trial. Lancet Haematol. 2021 May;8(5):e344-e354. doi: 10.1016/S2352-3026(21)00028-4. Epub 2021 Mar 23.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country: Germany France Italy

summary: The main purpose of this study is to evaluate the efficacy of LNP023 in patients with PNH, showing signs of active hemolysis despite treatment with SoC (defined as an antibody with anti C5 activity).


title: Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?

acronym: EMAVID

summary:
The majority of abortions in the United Kingdom (UK) are performed before 9 weeks (63 days) gestation using a method known as Early Medical Abortion (EMA). EMA involves an assessment visit and provision of two types of medication .

The assessment visit usually involves Ultrasound to confirm gestation, detailed personal history, safeguarding assessment and contraception planning, before arranging treatment and follow up.

The process is long and lots of information is given to women attending the service. In NHS Lothian (National Health Service, Lothian Health Board), the average appointment length for combined assessment and provision of the first part of treatment is 3 hours.

Despite how common abortion is ( 1 in 3), many women presenting for abortion care are not aware of what the procedure will involve. This may in part to the social stigma surrounding abortion and unintended pregnancy in general. This stigma can in turn result in feelings of anxiety and shame about the decision to terminate a pregnancy.

There is evidence that short videos shown to patients prior to abortion or contraception consultations can improve their ability to recall information and can make them feel more confident about the procedure.

Additionally, abortion care providers have found patients who have seen videos to be better prepared and informed and this allows consultations to progress more easily and allow greater time for discussion of contraceptive methods.

We have prepared a video approximately 3 minutes in length to provide information about EMA. It summarises the process described above using simple language and animated characters. The video has been translated into French, Portuguese and Swedish and has been adapted to reflect subtle differences in practice and law in these countries. We have partners in services in these three countries who will be conducting the trial there in accordance with this protocol and their own local ethics and clinical governance requirements.

primary_purpose: Health Services Research

ReferenceCitation: Michie L, Cameron ST, Glasier A, Johnstone A. Giving information about the contraceptive implant using a DVD: is it acceptable and informative? A pilot randomised study. J Fam Plann Reprod Health Care. 2016 Jul;42(3):194-200. doi: 10.1136/jfprhc-2015-101186. Epub 2015 Aug 6.

ReferenceCitation: Powell-Jackson R, Glasier A, Cameron ST. Benefits of using a digital video disk for providing information about abortion to women requesting termination of pregnancy. Contraception. 2010 Jun;81(6):537-41. doi: 10.1016/j.contraception.2010.01.015. Epub 2010 Feb 19.

ReferenceCitation: Reynolds-Wright JJ, Belleuvre F, Daberius A, Faucher P, Gemzell-Danielsson K, Cameron ST. Information on early medical abortion for women using an audiovisual animation vs face-to-face consultation: A consortium randomized and quasi-randomized trial. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1611-1617. doi: 10.1111/aogs.13944. Epub 2020 Jul 12.

ipd_sharing_description: Only anonymised responses to questionnaire will be shared between sites.

lead_sponsor: NHS Lothian

location_country:
Sweden
France
United Kingdom

location_facility: Chalmers Centre for Sexual and Reproductive Health


title: Study of Psychological and Addictive Profile of Patients With Buerger's Disease

acronym: ADDICTAO

summary:
Background: Buerger's disease (thromboangiitis obliterans or TAO) is a rare disease (1/ 10 000) characterized by the development of segmental thrombotic occlusions of the medium and small arteries of the extremities. Afflicted patients are mostly young, male, inveterate tobacco (or cannabis) smokers who present with distal extremity ischemia, ischemic ulcers, of the toes or fingers. Large arteries are typically spared, as are the coronary, cerebral, and visceral circulations. Patients with TAO often suffer from severe ischemic pain and tissue loss culminating in minor and major limb amputation. Clinical diagnostic criteria generally include history of tobacco abuse; age of onset less than 50 years; infrapopliteal, segmental arterial occlusions with sparing of the proximal vasculature; frequent distal upper extremity arterial involvement (Raynaud's syndrome or digital ulceration); superficial phlebitis; and exclusion of arteriosclerosis, diabetes, true arteritis, proximal embolic source, and hypercoagulable states.

While the cause of Buerger's disease remains unknown, the disease onset and clinical course are inextricably linked to tobacco (or cannabis) abuse. Tobacco abstinence generally results in disease quiescence and remains the mainstay of treatment. For some unknown reason, clinicians observed that TAO patients rarely discontinue smoking even though amputation is usually the inevitable consequence and the only method available of controlling pain and ulceration. Few studies were realized and Hofer-Mayer and coll. found remarkable personality features comparing to coronary patients: TAO patients significantly changed their place of work more often, had more absenteeism from work, smoked more before the illness and continued to smoke more frequently during their illness, were more often single or divorced and had more conflicts in their relationships. Those facts led us to explore their psychopathology and their addictive profile.

Purpose: Search the prevalence of personality disorders in Buerger's patients who present with tobacco or cannabis smoking.

Hypothesis: Patients with Buerger's disease show remarkable personality features (psychological and addictive profile) which are vulnerability factors to stop smoking (tobacco or cannabis) compared to patients with atheromatous arteritis.

lead_sponsor: University Hospital, Lille

location_facility: Georges Pompidou European Hospital, Paris


title: Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation

acronym: DIRECT-DBS

summary: The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

lead_sponsor: Boston Scientific Corporation

location_country: Germany France Netherlands

location_facility:
Academisch Medisch Centrum
Universitaetsklinikum Wuerzburg
CHU Grenoble - Hopital Michallon


title: SEMEiotic Oriented Technology for Individual's CardiOmetabolic Risk Self- assessmeNt and Self-monitoring

acronym: SEMEOTICONS

summary:
Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse, high blood lipids or sugar and arterial hypertension. Systems for self-learning and self-monitoring may help people improve and maintain a healthy lifestyle through tailored suggestions about diet, weight control, physical activity, fatigue,stress.

SEMEOTICONS exploits the human face as an indicator of individual's health status and translates signs obtained from the face using contactless sensors into measures and descriptors to be automatically evaluated by a an interactive smart mirror. This "Wize Mirror" extracts descriptors from videos, images and gas concentration signals and integrates them in a virtual model used to compute and trace the evolution of an individual's wellness index. A health diary enables each individual to evaluate and personally relate his/her lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution of the wellness index and of each descriptor, to provide useful suggestions on correct lifestyle self-monitoring.

The purpose of this study is assess the accuracy of the information derived from the Wize Mirror in expressing the health status of the individual.

The reproducibility and repeatability study will evaluate whether measurements are stable over short time spans and whether they are influenced by meals light and temperature conditions.

To verify whether the Wize Mirror is able to detect variations in physical and emotional health status with appropriate lifestyle changes, the validation study will cross-check measurements from the Wize Mirror against reference clinical tests at enrolment and after 3 months of personalized suggestions for healthy behavior.

Reference tests include

Physician visit
Measurement of blood oxygen content and skin end products of sugar metabolism,body composition, energy expenditure, vascular function
Laboratory profile and exhaled gas composition
Questionnaires on quality of life and lifestyle (food, sleep, physical activity, smoking, alcohol, stress).

Wize Mirror measures include

3D reconstruction of face images for roundness, color, stress and fatigue
Heart and respiratory rate
Detection of skin sugar metabolism end-products and of eye lipid deposits
Small vessel vasodilating ability with local heating The results will allow to assess whether the Wize Mirror is easy to use and helpful for self-monitoring of cardio-metabolic risk.

lead_sponsor: Istituto di Fisiologia Clinica CNR

location_country: France Italy

location_facility: Centre de Recherche en Nutrition Humaine

location_facility: Istituto di Fisiologia Clinica del CNR UOS Milano


title: XERAD: Open-Label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda®) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Diagnosed Brain Metastasis

acronym: XERAD

summary: This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with capecitabine or another systemic therapy in the WBRT only group.

lead_sponsor: Hoffmann-La Roche

intervention_type: Radiation


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-part Study of Orally Administered JNJ-54257099 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part 1) and Food-effect (Part 2) in Healthy Subjects, and Multiple Doses in Subjects With Chronic Hepatitis C Infection (Part 3)

summary:
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be assessed in healthy adult subjects and in adult subjects with CHC infection.

Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2 assigned to placebo), in a fasted state.

The planned dose-escalation scheme may be changed based on the emerging PK and safety data. Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK) profile, and the presence of an acceptable safety profile.

Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part 1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14 days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be selected, however this depends on the evaluation of available PK and safety data from Part 1 of the study.

Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7 consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed state. The treatment is anticipated to be administered in a once daily dose regimen or a twice daily dose regimen. The dose and dose regimen to be administered will be determined by the Sponsor depending on the PK and safety outcomes of previous cohorts.

lead_sponsor: Alios Biopharma Inc.

location_country:
Georgia
France
Moldova, Republic of

location_facility: Biotrial Arensia


title: Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation.

acronym: VAPRED

summary:
The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation.

The patients are included in the study from the anticoagulant treatment cessation. An ED score and a blood sample are performed at this time and one month later. Then, the patients are followed up by phone for 2 years.

ReferenceCitation: Agnelli G, Prandoni P, Santamaria MG, Bagatella P, Iorio A, Bazzan M, Moia M, Guazzaloca G, Bertoldi A, Tomasi C, Scannapieco G, Ageno W; Warfarin Optimal Duration Italian Trial Investigators. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. Warfarin Optimal Duration Italian Trial Investigators. N Engl J Med. 2001 Jul 19;345(3):165-9.

ReferenceCitation: Agnelli G, Prandoni P, Becattini C, Silingardi M, Taliani MR, Miccio M, Imberti D, Poggio R, Ageno W, Pogliani E, Porro F, Zonzin P; Warfarin Optimal Duration Italian Trial Investigators. Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med. 2003 Jul 1;139(1):19-25.

ReferenceCitation: Bosson JL, Riachi M, Pichot O, Michoud E, Carpentier PH, Franco A. Diameters of acute proximal and distal deep venous thrombosis of the lower limbs. Int Angiol. 1998 Dec;17(4):260-7.

ReferenceCitation: Cushman M, Folsom AR, Wang L, Aleksic N, Rosamond WD, Tracy RP, Heckbert SR. Fibrin fragment D-dimer and the risk of future venous thrombosis. Blood. 2003 Feb 15;101(4):1243-8. Epub 2002 Sep 26.

ReferenceCitation: Eichinger S, Minar E, Bialonczyk C, Hirschl M, Quehenberger P, Schneider B, Weltermann A, Wagner O, Kyrle PA. D-dimer levels and risk of recurrent venous thromboembolism. JAMA. 2003 Aug 27;290(8):1071-4.

ReferenceCitation: Emmerich J, Fiessinger JN. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304.

ReferenceCitation: Fattorini A, Crippa L, Vigano' D'Angelo S, Pattarini E, D'Angelo A. Risk of deep vein thrombosis recurrence: high negative predictive value of D-dimer performed during oral anticoagulation. Thromb Haemost. 2002 Jul;88(1):162-3.

ReferenceCitation: Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, Turpie AG, Green D, Ginsberg JS, Wells P, MacKinnon B, Julian JA. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med. 1999 Mar 25;340(12):901-7. Erratum in: N Engl J Med 1999 Jul 22;341(4):298.

ReferenceCitation: Kuruvilla J, Wells PS, Morrow B, MacKinnon K, Keeney M, Kovacs MJ. Prospective assessment of the natural history of positive D-dimer results in persons with acute venous thromboembolism (DVT or PE). Thromb Haemost. 2003 Feb;89(2):284-7.

ReferenceCitation: Palareti G, Legnani C, Cosmi B, Guazzaloca G, Pancani C, Coccheri S. Risk of venous thromboembolism recurrence: high negative predictive value of D-dimer performed after oral anticoagulation is stopped. Thromb Haemost. 2002 Jan;87(1):7-12.

ReferenceCitation: Palareti G, Legnani C, Cosmi B, Valdré L, Lunghi B, Bernardi F, Coccheri S. Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia. Circulation. 2003 Jul 22;108(3):313-8. Epub 2003 Jul 7.

ReferenceCitation: Pernod G, Mossuz P, Polack B. Optimized factor V gene mutation detection using buffy-coat direct PCR. Biotechniques. 1997 May;22(5):837, 840, 841.

ReferenceCitation: Piovella F, Crippa L, Barone M, Viganò D'Angelo S, Serafini S, Galli L, Beltrametti C, D'Angelo A. Normalization rates of compression ultrasonography in patients with a first episode of deep vein thrombosis of the lower limbs: association with recurrence and new thrombosis. Haematologica. 2002 May;87(5):515-22.

ReferenceCitation: Prandoni P, Lensing AW, Prins MH, Bernardi E, Marchiori A, Bagatella P, Frulla M, Mosena L, Tormene D, Piccioli A, Simioni P, Girolami A. Residual venous thrombosis as a predictive factor of recurrent venous thromboembolism. Ann Intern Med. 2002 Dec 17;137(12):955-60.

ReferenceCitation: Schulman S, Rhedin AS, Lindmarker P, Carlsson A, Lärfars G, Nicol P, Loogna E, Svensson E, Ljungberg B, Walter H. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group. N Engl J Med. 1995 Jun 22;332(25):1661-5.

ReferenceCitation: Schulman S, Granqvist S, Holmström M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Lärfars G, Leijd B, Linder O, Loogna E. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Trial Study Group. N Engl J Med. 1997 Feb 6;336(6):393-8.

ReferenceCitation: Schulman S. Clinical practice. Care of patients receiving long-term anticoagulant therapy. N Engl J Med. 2003 Aug 14;349(7):675-83. Review.

ReferenceCitation: Sebastian JL, Torre DM. Residual venous thrombosis and recurrent thromboembolism. Ann Intern Med. 2003 Aug 19;139(4):303; author reply 304.

lead_sponsor: University Hospital, Grenoble

location_facility: Vascular Medecine Departement - University Hospital of Grenoble


title: Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

summary: The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients with moderate chronic hepatic impairment and in matched healthy subjects.

lead_sponsor: Bial - Portela C S.A.

location_country:
Russian Federation
France

location_facility:
Biotrial, 7-9 rue Jean-Louis Bertrand
City clinical Hospital N°3
City clinical Hospital N°64


title: Phase IIIb, Multicenter, Single-Arm Open-Label Study, Supporting the Development and the Validation of the MATHYS Scale (Multidimensional Assessment of THYmic States) in a Population of Bipolar Patients Treated With Olanzapine, Either in-Label (Manic and Mixed Patients) and Off-Label (Hypomanic and Bipolar Depression)

summary: A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.


title: Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)

summary: Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The study hypothesis is to show a highest correlation between the new product and the reference methods.

lead_sponsor: Philipp Schuetz

location_country: Germany France Switzerland

location_facility: Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)

location_facility: Pitié Salpetrière. Groupement hospitalière universitaire Est


title: A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State

summary:
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.

The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).

lead_sponsor: Novo Nordisk A/S

location_country: Germany France Israel


title: A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

summary: This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.


summary: This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.


title: Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospital Universitaire Hop Huriez


summary:
The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.

This is a multi-centre study on 60 patients who have a lower limb ulcer.

lead_sponsor: Integra LifeSciences Services

location_country: France Italy Greece

location_facility: Aristotle University of Thessaloniki - Papageorgiou General Hospital


title: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

summary:
In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction.

However, weight bearing forces on the head of the first metatarsal acting at a distance from the osteotomy site subject the construct to an important dorsiflexion stress. Fixation strength being the important consideration led to design the B-BOP® Lock plate, specifically dedicated to basal osteotomy of the first metatarsal, with the following characteristics:

plantar positioning to obtain the best stability and resistance while reducing the implant bulkiness;
anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on tension, it offers an innovative and unique basal osteotomy fixation solution.

The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology.

The purpose of this study is to collect and publish data from several centers, several users.

location_country:
Lebanon
France
United Kingdom

location_facility: Centre Hospitalier universitaire Notre Dame de secours


title: BRAINI2-Paediatric : Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury: a European, Prospective, Multicentre Clinical Study

summary:
Mild traumatic brain injury (TBI), defined by a Glasgow Coma Scale (GCS) score of 13 to 15, is the cause of many consultations in paediatric emergency departments (1), even though it is a rare cause of acute complication: approximately 10% of children present with intracranial lesions (ICL) on the CT scan and less than 1% require neurosurgical intervention (2). Although ICLs remain a serious complication requiring rapid diagnosis, brain CT scans, the gold standard diagnostic test, cannot be performed routinely because many children would be unnecessarily exposed to ionising radiation associated with an increased risk of cancer (3). In recent years, several clinical decision rules for the management of mTBI have therefore been developed with the aim of identifying children at high or very low risk of ICL in order to better target CT scan indications. Despite this, the rate of CT scans performed has remained high, up to 35%, and has not decreased with the application of these clinical decision rules (4).

Furthermore, even though the majority of children and adolescents recover quickly after mTBI, nearly 30% will present symptoms such as headaches, dizziness, asthenia, memory, concentration or sleep disorders persisting beyond one month with a possible impact on their quality of life (5). Thus, there is a need to develop new strategies to (i) limit the use of CT scans while minimising the risk of late diagnosis of ICL, (ii) identify children with a higher risk of adverse outcome and/or post-concussive symptoms.

One of the most promising strategies is the use of brain-based blood biomarkers. This study therefore aims to provide new knowledge on two of them, GFAP and UCH-L1 (6,7), in particular by using an automated test combining them (the VIDAS® TBI test developed by bioMérieux) in order to improve the management of CT in the paediatric population at the diagnostic and prognostic levels.

lead_sponsor: Nantes University Hospital

location_country: Germany France Switzerland Spain

location_facility: Hospital Universitari Vall d'Hebron (ICS)

location_facility: Klinikum rechts der Isar, Technical University of Munich

location_facility: Hospital Infantil Universitario Nino Jesus


title: Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal

acronym: P-NeLoP

summary: The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study

summary: Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

lead_sponsor: University of Zurich

location_country: France Switzerland Spain

location_facility: Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital

location_facility: Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital


title: Comparison of the Safety and Efficacy of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week,Randomized, Double-blind, Comparative, Parallel-group Study.

acronym: REST

summary:
The primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.

Secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.

lead_sponsor: Sanofi

location_country: Sweden France Spain


title: High Resolution Virtual Chromoendoscopy Versus Seattle Protocol for the Surveillance of Barrett's Esophagus: Impact on the Detection of High-grade Dysplasia and Adenocarcinoma Lesions

acronym: CONVERSE

summary: The investigators hypothesize that careful examination of Barrett's esophagus by high-resolution endoscopy combined with virtual chromoendoscopy could replace the Seattle protocol for Barrett's esophagus monitoring and detection of dysplasic lesions, and thus modify existing recommendations.

primary_purpose: Diagnostic

location_facility: Public Assistance - Paris hospitals - Cochin hospital

location_facility: Public Assistance- Paris Hospitals - Georges Pompidou European Hospital


title: An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.

summary: The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.

ReferenceCitation: Bahleda R, Sessa C, Del Conte G, Gianni L, Capri G, Varga A, Oprea C, Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1188-96. doi: 10.1007/s10637-014-0119-0. Epub 2014 Jun 6.

location_country: France Switzerland Italy

location_facility:
Investigational Site Number 250001
Investigational Site Number 380001
Investigational Site Number 756001


title: A Multi-centre, Randomized, Double-blind, Placebo Controlled, Two-period, Crossover Proof-of-concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056

summary: This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.

ReferenceCitation: Jacquemont S, Curie A, des Portes V, Torrioli MG, Berry-Kravis E, Hagerman RJ, Ramos FJ, Cornish K, He Y, Paulding C, Neri G, Chen F, Hadjikhani N, Martinet D, Meyer J, Beckmann JS, Delange K, Brun A, Bussy G, Gasparini F, Hilse T, Floesser A, Branson J, Bilbe G, Johns D, Gomez-Mancilla B. Epigenetic modification of the FMR1 gene in fragile X syndrome is associated with differential response to the mGluR5 antagonist AFQ056. Sci Transl Med. 2011 Jan 5;3(64):64ra1. doi: 10.1126/scitranslmed.3001708.

lead_sponsor: Novartis


title: An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.

summary: The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings

lead_sponsor: Eli Lilly and Company

location_country: Germany France Greece

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial

acronym: EndoPOP

summary:
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.

Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).

lead_sponsor: Septodont

location_facility:
Cabinet dentaire
Centre de santé dentaire Chevaleret
Centre dentaire Flandre
Cabinet Dentaire


title: Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women

summary: Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.

ReferenceCitation: Brink E, Coxam V, Robins S, Wahala K, Cassidy A, Branca F; PHYTOS Investigators. Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women: a randomized, double-blind, placebo controlled study. Am J Clin Nutr. 2008 Mar;87(3):761-70.

lead_sponsor: TNO

location_country: Netherlands France Italy

location_facility: National Institute for Research on Food an Nutrition

location_facility: Institute National de la Recherche Agronomique


title: Creation of a Register of Patients With Neonatal-onset Epileptic Encephalopathy

acronym: IMPROVE

summary:
Electrical activity emerges in the third trimester of pregnancy, plays an important role in the construction of cortical maps, and is impaired in patients with severe early epileptic encephalopathies (EOEE). EOEE are rare and severe epileptic syndromes characterized by epilepsy that begins within the first three months of life and is associated with rapid deterioration of motor, cognitive and behavioral skills.

There is a genetic basis for the EOEE. Together with other laboratories, the investigators have identified de novo pathogenic variants in the KCNQ2 gene encoding the Kv7.2 subunit of the Kv7 / M potassium channel, a channel known to control neuronal excitability in the brain and spinal cord. via the current M (IM). Pathogenic variants of the KCNQ2 gene represent the main cause of EOEE and the term KCNQ2-related epileptic encephalopathy (KCNQ2-REE) is now used to define this condition.

KCNQ2-REE patients have a remarkably homogeneous phenotype at the start, with epilepsy that begins in the first days after birth, seizures that result in tonic muscle spasms that last from 1 to 10 seconds, and an interictal EEG called "suppression-burst". "That is, paroxysmal bursts of activity interspersed with periods of electrical silence. In this group, more than 50% of the patients present a remission of the epilepsy and a quasi-normalization of the EEG which can occur a few weeks to several months after the onset of the seizures. Despite this positive evolution in terms of seizures, the developmental progression is abnormal and the phenotype is severe with an absence of language, autistic behavior and a subsequent development of motor disorders such as diplegia, spasticity, ataxia or dystonia.

The ambition of this project is to increase knowledge of epileptic encephalopathies linked to KCNQ2 at the clinical and molecular levels, to decipher the pathophysiological mechanisms and to propose therapeutic strategies.

This project aims to better describe the clinical, EEG, imaging, developmental and long-term follow-up characteristics of patients carrying the KCNQ2 mutation identified in the laboratory.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
APHP Robert Debré
CHU Tours
Hospices Civils Lyon
Hôpital La Timone
APHP Pitié Salpêtrière
CHU Montpellier
CHU Angers
CHU Bordeaux
CHU Brest
CHU Rennes
CHU Toulouse
CHU Limoges
CHRU Strasbourg
Hôpital Necker
CHRU Lille


title: Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation

summary: The aim of this study is to determine whether alternating courses of cyclophosphamide, doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus rituximab followed by total body irradiation [TBI]/high dose cytarabine [ARA-C]/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time to treatment failure compared to CHOP plus rituximab followed by standard PBSCT (dexamethasone, carmustine, cytarabine, etoposide, and melphalan [Dexa-BEAM]/TBI/high dose cyclophosphamide) in patients with untreated mantle cell lymphoma.

ReferenceCitation: Dreyling M, Lenz G, Hoster E, Van Hoof A, Gisselbrecht C, Schmits R, Metzner B, Truemper L, Reiser M, Steinhauer H, Boiron JM, Boogaerts MA, Aldaoud A, Silingardi V, Kluin-Nelemans HC, Hasford J, Parwaresch R, Unterhalt M, Hiddemann W. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network. Blood. 2005 Apr 1;105(7):2677-84. Epub 2004 Dec 9.

ReferenceCitation: Lenz G, Dreyling M, Hoster E, Wörmann B, Dührsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. Epub 2005 Jan 24.

ReferenceCitation: Hermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, Szymczyk M, Bouabdallah R, Kneba M, Hallek M, Salles G, Feugier P, Ribrag V, Birkmann J, Forstpointner R, Haioun C, Hänel M, Casasnovas RO, Finke J, Peter N, Bouabdallah K, Sebban C, Fischer T, Dührsen U, Metzner B, Maschmeyer G, Kanz L, Schmidt C, Delarue R, Brousse N, Klapper W, Macintyre E, Delfau-Larue MH, Pott C, Hiddemann W, Unterhalt M, Dreyling M; European Mantle Cell Lymphoma Network. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. doi: 10.1016/S0140-6736(16)00739-X. Epub 2016 Jun 14.

ReferenceCitation: Delfau-Larue MH, Klapper W, Berger F, Jardin F, Briere J, Salles G, Casasnovas O, Feugier P, Haioun C, Ribrag V, Thieblemont C, Unterhalt M, Dreyling M, Macintyre E, Pott C, Hermine O, Hoster E; European Mantle Cell Lymphoma Network. High-dose cytarabine does not overcome the adverse prognostic value of CDKN2A and TP53 deletions in mantle cell lymphoma. Blood. 2015 Jul 30;126(5):604-11. doi: 10.1182/blood-2015-02-628792. Epub 2015 May 28.

ReferenceCitation: Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.

ReferenceCitation: Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Böttcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.

lead_sponsor: European Mantle Cell Lymphoma Network

location_country: Germany Poland France

location_facility: The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology

location_facility: Groupe D´Etudes des Lymphomes De l´Adulte (GELA)


title: An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

summary: This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.


title: Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score

acronym: Biper

summary: The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Pasteur 2 Hospital - University Hospital

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study

summary: The aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).

lead_sponsor: University Hospital, Geneva

location_country: France Switzerland

location_facility: Division of Gastroenterology, University Hospital

location_facility: Centre Hospitalier Universitaire Vaudois


title: Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)

acronym: ValidBMTI

summary:
The group of experts at HAS has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications International Classification of Diseases (CIM) CIM 11 and Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation.

This orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned.

The BMTi, a battery of third-generation tests (after the Rapid battery of evaluation of the cognitive functions (BREV) and then the Evaluation of cognitive functions and learning of the child (EDA)) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. .

The research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_country: France Martinique

location_facility:
Cabinet du Dr Gelbert
Cabinet du Dr Willig
CH Versailles - André Mignot
CHU de Rouen
Cabinet du Dr Reynaud
Centre Médical Pédiatrique Flammarion
Cabinet du Dr Lubelski
Cabinet du Dr Dulorme
Cabinet du Dr Werner
Cabinet du Dr Kochert
Cabinet du Dr Pineau
Hôpital Saint Eloi - Montpellier
Cabinet du Dr Vurpillat-Almanza
Centre Paris Santé Réussite
Cabinet du Dr Piollet
Cabinet du Dr Cahn-Sellem

intervention_type: Behavioral


title: Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy

acronym: IRIS 2

summary: This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.

lead_sponsor: Pixium Vision SA

location_country:
Spain
United Kingdom
Austria
France
Germany

location_facility: CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)

location_facility: Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf

location_facility: Universitäts KlinikumKlinik für Augenheilkunde Freiburg

location_facility: Clinique Ophtalmologique du CHU de Nantes

location_facility: Dept. of Ophthalmology, University of Bonn

location_facility: Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild


title: Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.

summary:
This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT).

The main endpoint will be evaluated by a blinded endpoint committee.

ReferenceCitation: Le Duc G, Miladi I, Alric C, Mowat P, Bräuer-Krisch E, Bouchet A, Khalil E, Billotey C, Janier M, Lux F, Epicier T, Perriat P, Roux S, Tillement O. Toward an image-guided microbeam radiation therapy using gadolinium-based nanoparticles. ACS Nano. 2011 Dec 27;5(12):9566-74. doi: 10.1021/nn202797h. Epub 2011 Nov 9.

ReferenceCitation: Lux F, Tran VL, Thomas E, Dufort S, Rossetti F, Martini M, Truillet C, Doussineau T, Bort G, Denat F, Boschetti F, Angelovski G, Detappe A, Crémillieux Y, Mignet N, Doan BT, Larrat B, Meriaux S, Barbier E, Roux S, Fries P, Müller A, Abadjian MC, Anderson C, Canet-Soulas E, Bouziotis P, Barberi-Heyob M, Frochot C, Verry C, Balosso J, Evans M, Sidi-Boumedine J, Janier M, Butterworth K, McMahon S, Prise K, Aloy MT, Ardail D, Rodriguez-Lafrasse C, Porcel E, Lacombe S, Berbeco R, Allouch A, Perfettini JL, Chargari C, Deutsch E, Le Duc G, Tillement O. AGuIX(®) from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine. Br J Radiol. 2019 Jan;92(1093):20180365. doi: 10.1259/bjr.20180365. Epub 2018 Sep 18. Review.

ReferenceCitation: Verry C, Dufort S, Barbier EL, Montigon O, Peoc'h M, Chartier P, Lux F, Balosso J, Tillement O, Sancey L, Le Duc G. MRI-guided clinical 6-MV radiosensitization of glioma using a unique gadolinium-based nanoparticles injection. Nanomedicine (Lond). 2016 Sep;11(18):2405-17. doi: 10.2217/nnm-2016-0203. Epub 2016 Aug 16.

lead_sponsor: University Hospital, Grenoble

location_facility: Centre hospitalier universitaire Grenoble-Alpes

location_facility: Hospices Civils de Lyon-Hôpital Lyon Sud

location_facility: Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie

location_facility: Institut de Cancérologie de Lorraine ALEXIS VAUTRIN