title: A Phase 1 Dose Escalation and Expansion Study of CID-103, an Anti-CD38 Antibody, in Patients With Previously Treated Relapsed or Refractory Multiple Myeloma

summary: Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities.

lead_sponsor: CASI Pharmaceuticals, Inc.

location_facility:
Sarah Cannon
CHU Rennes - Pontchaillou
CHU de Nantes - Hôpital Hôtel-Dieu
Gustave Roussy Cancer Center


type: Other Identifier

title: Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

acronym: HaWPYC

summary: HaWPYC is an international Post-Market Clinical Follow-up (PMCF) to collect post-market safety and performance data on commercially available Pyrocarbon (PyC) hand and wrist implants used in this study. Data may be used for Post-Market Surveillance, and regulatory requirements.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Stryker Trauma GmbH

location_country: Switzerland France

location_facility: Orthopedic Surgeon (Dr. med. Dietmar Bignion)

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes

summary: This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.

status: Active, not recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

lead_sponsor: Zimmer Biomet

location_country: Slovenia France

location_facility:
CHU Lapeyronie
Hospital Novo Mesto
CHU Cote de Nacre
Hôpital Renée Sabran

intervention_type: Other


title: Effect of Starter Formula With Symbiotic on Microbiota Balance

summary: The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Société des Produits Nestlé (SPN)

location_country: Poland France

location_facility:
Hôpital Nord
Hôpital Saint Joseph
Hôpital de la Conception
The Medical University of Warsaw

status_simplified: Completed


title: Study of Prognosis Value of Protein S100Beta and Copeptine in Seizure in the Emergency Department

acronym: BISTRO

summary: We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

time_perspective: Prospective

lead_sponsor: Bistro Study Group

sponsor_collaborators:
Bistro Study Group
Groupe Hospitalier Pitie-Salpetriere
Barts & The London NHS Trust

location_country:
United Kingdom
France

location_facility: Royal London Hospital, Barts Health NHS Trust


type: EudraCT Number

title: Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)

acronym: AIMM

summary:
The objective of the present trial is:

to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma.
to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP
to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

status: Withdrawn

primary_purpose: Treatment

lead_sponsor: Valerio Therapeutics

location_facility: Hôpital Saint Louis. Service de dermatologie

intervention_type: Biological

status_simplified: Unknown


title: Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With Velcade® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)

summary:
Primary Objectives:

Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor 1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients with recurrent, refractory multiple myeloma (MM).

Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade®.

Secondary Objectives :

Study Part 1:

To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs)
To assess the biological activity of AVE1642 (saturation of the receptors and down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells (PBMC) and granulocytes
To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1 system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells when technically possible
To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3
To assess clinical efficacy (complete response [CR], partial response [PR], minimal response [MR] and stabilization) based on the European group for Blood and Marrow Transplantation (EBMT) criteria, when possible
To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642

Study Part 2:

To detect any PK or PD interaction between AVE1642 and Velcade®
To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria when appropriate
To assess biological activity of AVE1642 in combination with Velcade® on malignant plasma cells collected from bone marrow aspirates: saturation and down-regulation of the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway of the IGF-1 system (pAkt, pErk) when feasible
To detect immunogenicity reaction (HAHA)
To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active

lead_sponsor: Sanofi

location_country: Italy France

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 250002

intervention_type: Drug


title: Characterization of the Mechanisms of Action of Resistance to Azacitidine in High-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia With Multilineage Dysplasia

summary:
Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71 years). IPSS classification defines low risk (Low and Intermediate 1), and high risk (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been mainly achieved through a rigorous empirical and clinical research, but the molecular mechanisms by which this molecule exerts its effects remain poorly characterized. The primary mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that favor traduction inhibition. The impact of this molecule on various cell death programs involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly known.

The research program and clinical studies we proposed focus on two major aspects:

- Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of apoptosis versus autophagy.

- Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce different types of cell death (apoptosis or autophagy).

status: Unknown status

ReferenceType: derived

ReferenceCitation: Cluzeau T, Robert G, Mounier N, Karsenti JM, Dufies M, Puissant A, Jacquel A, Renneville A, Preudhomme C, Cassuto JP, Raynaud S, Luciano F, Auberger P. BCL2L10 is a predictive factor for resistance to azacitidine in MDS and AML patients. Oncotarget. 2012 Apr;3(4):490-501. doi: 10.18632/oncotarget.481.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Monaco France

location_facility:
Centre Antoine Lacassagne
CHU de Nice - Hôpital de l'Archet
CH d'Antibes
CH Princesse Grace

lead_sponsor_type: academique


title: Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy

acronym: CHECKMATE

summary:
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease. Heart transplantation remains the reference treatment for the terminal stage of the disease but although this is an effective therapy, it does engender ethical, social, economic and legal problems. It also requires irreproachable and costly logistics, immuno-suppressor treatment and a lifetime of follow-ups. In particular, the number of donors has been going down steadily for several years in most countries which offer a heart transplant programme and some patients cannot take advantage of being added to a waiting list for a graft (age, co-morbidities…).

It is in this context that, alongside the medical treatments for cardiac insufficiency, other therapeutic strategies were developed, including resynchronization and long-term mechanical circulatory support. The progress made in resynchronization is at several levels: better understanding of the action mechanisms, the development and improvement of equipment specifically dedicated to resynchronization and prospective and randomized clinical trials which have scientifically validated this technique.

Simultaneously, many studies were published evaluating long term support with mechanical circulatory support (MCS), excluding light devices, as a bridge to transplant or an alternative to a transplant. It is also recognized that mechanical circulatory support with a new generation of continuous flow assist device improved the quality of life and functional capacity, with a reduced risk of device failure and infrequent need for replacement.

The "Achilles heel" of cardiac resynchronization remains the 20 to 40% of patients who respond barely or not at all. Among this population of patients, some are not candidates for a transplantation and long-term mechanical circulatory support by axial pump is an alternative to be considered. We elaborated an original randomized pilot study for these patients in order to evaluate their survival and their quality of life, to define if they should be proposed a left ventricular assist device (LVAD)or not.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Thoratec Europe Ltd

location_country: Germany France

location_facility: Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität

intervention_type: Device


title: A Prospective Multicenter, Study to Evaluate the Safety and Effectiveness of the Presbyopia Algorithm for Hyperopia and Hyperopic Astigmatism Using LASIK

acronym: PresbyLASIK

summary: The Presbyopia Algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance correction). The treatment algorithm provides a bilateral, multifocal ablation with a center near addition, thereby allowing good focus over a range of object distances.

lead_sponsor: Technolas Perfect Vision GmbH

location_country: Spain France

location_facility:
Dr. Roure
Vision Future Nice
Clinique de la Vision Paris
Instituo Oftalmologico Casteanera

intervention_type: Procedure


title: A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's Disease

acronym: Foehn

summary: The purpose of this study is to determine whether Fipamezole is effective in the treatment of orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's disease.

lead_sponsor: Juvantia Pharma Ltd

sponsor_collaborators:
Juvantia Pharma Ltd
Santhera Pharmaceuticals

location_country: Portugal France

location_facility: Hôpital du Haut Lévêque, CHU de Bordeaux

location_facility: Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa


title: Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

summary: Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine ePortal for sharing information between diabetologist and type 1 diabetic patient is not inferior to a conventional care regarding metabolic results at 12 months.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.

ReferenceCitation: Farmer AJ, Gibson OJ, Dudley C, Bryden K, Hayton PM, Tarassenko L, Neil A. A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Diabetes Care. 2005 Nov;28(11):2697-702. doi: 10.2337/diacare.28.11.2697.

ReferenceCitation: Montori VM, Helgemoe PK, Guyatt GH, Dean DS, Leung TW, Smith SA, Kudva YC. Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Diabetes Care. 2004 May;27(5):1088-94. doi: 10.2337/diacare.27.5.1088.

ReferenceCitation: Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.

ReferenceCitation: Boizel R, Benhamou PY, Renard E; Accu-Chek Pocket Compass Study Group. Glucose monitoring and pump data management software operated on a personal digital assistant can contribute to improve diabetes control in CSII-treated patients. Diabetes Metab. 2007 Sep;33(4):314-5. doi: 10.1016/j.diabet.2007.03.001. Epub 2007 May 1. No abstract available.

ReferenceCitation: Young RJ, Taylor J, Friede T, Hollis S, Mason JM, Lee P, Burns E, Long AF, Gambling T, New JP, Gibson JM. Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2005 Feb;28(2):278-82. doi: 10.2337/diacare.28.2.278.

ReferenceCitation: Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159. doi: 10.1136/bmj.328.7449.1159.

ReferenceCitation: Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371.

ReferenceCitation: Tate DF, Jackvony EH, Wing RR. Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003 Apr 9;289(14):1833-6. doi: 10.1001/jama.289.14.1833.

ReferenceCitation: Trief PM, Sandberg J, Izquierdo R, Morin PC, Shea S, Brittain R, Feldhousen EB, Weinstock RS. Diabetes management assisted by telemedicine: patient perspectives. Telemed J E Health. 2008 Sep;14(7):647-55. doi: 10.1089/tmj.2007.0107.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of Besancon - Hospital Jean Minjoz

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital of Lyon (HCL Lyon sud)

location_facility: University Hospital of Caen (Hospital Côte de nacre)


title: Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

acronym: T-DEF

summary: This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.

lead_sponsor: CMC Ambroise Paré

location_facility: Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois

intervention_type: Diagnostic Test


title: Long-Term Observational Study of Translarna Safety and Effectiveness in Usual Care

summary: This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.

ReferenceCitation: Mercuri E, Muntoni F, Osorio AN, Tulinius M, Buccella F, Morgenroth LP, Gordish-Dressman H, Jiang J, Trifillis P, Zhu J, Kristensen A, Santos CL, Henricson EK, McDonald CM, Desguerre I; STRIDE; CINRG Duchenne Natural History Investigators. Safety and effectiveness of ataluren: comparison of results from the STRIDE Registry and CINRG DMD Natural History Study. J Comp Eff Res. 2020 Apr;9(5):341-360. doi: 10.2217/cer-2019-0171. Epub 2020 Jan 30.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

version: submittedVersion

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of California - eScholarship University of California

unpaywall_oa_status: hybrid

publisher_dissemination: Becaris Publishing Limited

lead_sponsor: PTC Therapeutics

collaborators: The John Walton Muscular Dystrophy Research Centre (TREAT-NMD)

collaborators: Cooperative International Neuromuscular Research Group

location_country:
Germany
Italy
Slovenia
Portugal
Hungary
Israel
Norway
Romania
Brazil
Sweden
Austria
United Kingdom
Latvia
Greece
Czechia
France

location_facility: II Policlinico Neurofisiopatologia (Edificio 11 G)

location_facility: Children Hospital - Children's Neurosciences Leeds TEACHING HOSPITALS NHS Trust

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria

location_facility: NIHR Lancashire Clinical Research Facility Royal Preston Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Semmelweis Egyetem II (Semmelweis University II)

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Sozialpädiatrisches Zentrum (SPZ) Charité Berlin

location_facility: Children's Hospital Alder Hey Children's Hospital NHS Trust

location_facility: Sheba Medical Center The Joseph Sagol EMG, Neuroscience Center

location_facility: Hospices Civils de Lyon Groupement Hospitalier Est - Bâtiment "Les Tilleuls"

location_facility: CHU de Clermont-Ferrand, hôpital Estaing

location_facility: Centro Hospitalar e Universitário de coimbra EPE - Hospital Pediátrico de Coimbra

location_facility: Szent László Kórház Gyermekneurológiai szakrendelés

location_facility: CHU de Bordeaux Hôpital Pellegrin Enfant

location_facility: Ospedale Molinette SCDU Neuropsichiatria Infantile AO Città della Salute e della Scienza di Torino

location_facility: St. Olavs hospital University children's clinical hospital

location_facility: CHU de Nancy Hôpital de Brabois-Enfants Rue du Morvan

location_facility: CHU de Toulouse Hôpital Pierre Paul Riquet

location_facility: Göteborgs Universitet Avdelningen för pediatrik vid institutionen för kliniska vetenskaper

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: UCL Great Ormond Street Institute of Child Health

location_facility: CHU de la Réunion - GHSR - GH Sud-Réunion

location_facility: Hospital das Clínicas da Universidade de São Paulo

location_facility: University Children's Hospital University Medical Centre Ljubljana

location_facility: IRCSS Istituto delle Scienze Neurologiche

location_facility: Centro Hospitalar do Porto EPE - Hospital Geral de Santo António

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Cardiomiologia e Genetica Medica Primo Policlinico

location_facility: CHU de Martinique - Hôpital P. Zobda-Quitman

location_facility: Spitalul Clinic de Copii "Dr. Victor Gomoiu" Sectia Clinica Neurologie Pediatrica

location_facility: Schneider Medical Center Tel Aviv University

location_facility: Klinik und Poliklinik f. Kinder- und Jugendmedizin

location_facility: Sozialmedizinisches Zentrum Süd Kaiser-Franz-Josef Spital mit Gottfried von Preyer´schen Kinderspital


title: ASTER: Anifrolumab Study for Treatment Effectiveness in the Real World Multi-National, Observational, Post-Launch Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

acronym: ASTER

summary: Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

sponsor_collaborators: AstraZeneca Parexel

location_country: Germany Italy Israel Denmark Sweden Austria Belgium Canada France


title: Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study

acronym: EASY TAVI

summary: The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method.

ReferenceCitation: Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Arnold SV, Reynolds MR, Wang K, Magnuson EA, Baron SJ, Chinnakondepalli KM, Reardon MJ, Tadros PN, Zorn GL, Maini B, Mumtaz MA, Brown JM, Kipperman RM, Adams DH, Popma JJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1207-1217. doi: 10.1016/j.jcin.2015.04.018.

ReferenceCitation: Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.

ReferenceCitation: Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004 Feb 18;43(4):698-703. doi: 10.1016/j.jacc.2003.11.026.

ReferenceCitation: Eggebrecht H, Mehta RH, Kahlert P, Schymik G, Lefevre T, Lange R, Macaya C, Mandinov L, Wendler O, Thomas M. Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): insights from the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry. EuroIntervention. 2014 Dec;10(8):975-81. doi: 10.4244/EIJV10I8A165.

ReferenceCitation: Faurie B, Abdellaoui M, Wautot F, Staat P, Champagnac D, Wintzer-Wehekind J, Vanzetto G, Bertrand B, Monsegu J. Rapid pacing using the left ventricular guidewire: Reviving an old technique to simplify BAV and TAVI procedures. Catheter Cardiovasc Interv. 2016 Nov 15;88(6):988-993. doi: 10.1002/ccd.26666. Epub 2016 Aug 11.

ReferenceCitation: Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.

ReferenceCitation: Karagoz T, Aypar E, Erdogan I, Sahin M, Ozer S, Celiker A. Congenital aortic stenosis: a novel technique for ventricular pacing during valvuloplasty. Catheter Cardiovasc Interv. 2008 Oct 1;72(4):527-30. doi: 10.1002/ccd.21695.

ReferenceCitation: Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schachinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.

ReferenceCitation: Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

ReferenceCitation: Navarini S, Pfammatter JP, Meier B. Left ventricular guidewire pacing to simplify aortic balloon valvuloplasty. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):426-7. doi: 10.1002/ccd.21810. No abstract available.

ReferenceCitation: Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

publisher_dissemination: Elsevier

ReferenceCitation: Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

ReferenceCitation: Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, Wendler O. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011 Jul 26;124(4):425-33. doi: 10.1161/CIRCULATIONAHA.110.001545. Epub 2011 Jul 11.

ReferenceCitation: Walther T, Hamm CW, Schuler G, Berkowitsch A, Kotting J, Mangner N, Mudra H, Beckmann A, Cremer J, Welz A, Lange R, Kuck KH, Mohr FW, Mollmann H; GARY Executive Board. Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry. J Am Coll Cardiol. 2015 May 26;65(20):2173-80. doi: 10.1016/j.jacc.2015.03.034. Epub 2015 Mar 15.

ReferenceCitation: Wenaweser P, Pilgrim T, Roth N, Kadner A, Stortecky S, Kalesan B, Meuli F, Bullesfeld L, Khattab AA, Huber C, Eberle B, Erdos G, Meier B, Juni P, Carrel T, Windecker S. Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes. Am Heart J. 2011 Jun;161(6):1114-24. doi: 10.1016/j.ahj.2011.01.025. Epub 2011 May 11.

ReferenceCitation: Vogel R, Meier B. Emergent mechanical and electrical guidewire pacing of the right ventricle for aystole in the cardiac catheterization laboratory. J Invasive Cardiol. 2005 Sep;17(9):490. No abstract available.

ReferenceCitation: Faurie B, Souteyrand G, Staat P, Godin M, Caussin C, Van Belle E, Mangin L, Meyer P, Dumonteil N, Abdellaoui M, Monsegu J, Durand-Zaleski I, Lefevre T; EASY TAVI Investigators. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2449-2459. doi: 10.1016/j.jcin.2019.09.029. Epub 2019 Sep 28.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

collaborators: Centre Recherche Cardio Vasculaire Alpes

location_facility: Groupement Hospitalier Mutualiste de Grenoble


title: Effectiveness and Organizational Conditions of Effectiveness of Telemedicine in Establishments Providing Care for the Dependent Elderly

acronym: EFFORT

summary: Study of interest of Telemedicine in establishments providing care for the dependent elderly (EHPAD in french) is a strategy for improving the course of care of residents, including the number not programmed hospitalizations, and a multidimensional analysis of the conditions of effectiveness of telemedicine will identify the keys to optimize its use.

ReferenceType: result

ReferenceCitation: Han JH, Morandi A, Ely EW, Callison C, Zhou C, Storrow AB, Dittus RS, Habermann R, Schnelle J. Delirium in the nursing home patients seen in the emergency department. J Am Geriatr Soc. 2009 May;57(5):889-94. doi: 10.1111/j.1532-5415.2009.02219.x.

ReferenceCitation: Morandi A, Han JH, Callison C, Ely EW, Schnelle JF. Delirium in nursing home residents across care transitions: a preliminary report. J Am Geriatr Soc. 2009 Oct;57(10):1956-8. doi: 10.1111/j.1532-5415.2009.02472.x. No abstract available.

ReferenceCitation: Vellas B. Integrating Frailty into Clinical Practice to Prevent the Risk of Dependency in the Elderly. Nestle Nutr Inst Workshop Ser. 2015;83:99-104. doi: 10.1159/000382092. Epub 2015 Oct 20.

oa_host_type: closed

publisher_dissemination: S. Karger AG

ReferenceCitation: Graverholt B, Forsetlund L, Jamtvedt G. Reducing hospital admissions from nursing homes: a systematic review. BMC Health Serv Res. 2014 Jan 24;14:36. doi: 10.1186/1472-6963-14-36.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

ReferenceCitation: Salles N, Saillour-Glenisson F, Sibe M, Langlois E, Kret M, Durrieu J, Arditi N, Abraham M, Perry F. Effectiveness and organizational conditions of effectiveness of telemedicine in nursing homes. A study protocol of a comparative prospective cohort (EFFORT study). Digit Health. 2021 Jan 24;7:2055207620982422. doi: 10.1177/2055207620982422. eCollection 2021 Jan-Dec.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: SAGE Publications

lead_sponsor: University Hospital, Bordeaux

location_facility:
EHPAD Le rétou
EHPAD Douceur de France
EHPAD résidence du Tertre
EHPAD Le home medocain Arsac
EHPAD Le Platane du Grand Parc
EHPAD Résidence les Carmes
EHPAD Cos villa Pia
EHPAD Fontaudin
EHPAD Jacqueline Auriol
EHPAD Le Clos Serena
EHPAD Le parc du Bequet
EHPAD Home Marie Curie
EHPAD Grand Bon Pasteur
EHPAD Les coteaux
EHPAD Henry Dunant
Résidence de Médicis
EHPAD CHU Bordeaux
EHPAD Residence Aime Cesaire
EHPAD Seguin
EHPAD Villa Bontemps
EHPAD Résidence La berge du lac
EHPAD Villa presentine
EHPAD Résidence l'Arousiney
EHPAD Manon Cormier


title: Comparative Assessment of Methods to Analyze MGMT as a Predictive Factor of Response to Temozolomide in Glioblastomas.

acronym: ECOM

summary: Treatment for newly diagnosed glioblastomas currently involves surgical resection followed by Temozolomide chemotherapy with concomitant radiotherapy, and then 6 cycles of Temozolomide in adjuvant. According to many studies, only those patients not expressing the enzyme repair MGMT benefit from the adjunction of Temozolomide. Therefore, many patients receive unnecessary treatment. The aim of this project is to compare different techniques for analysis of MGMT in order to choose the approach with the best cost/utility ratio, which will allow the selection of patients likely to respond to TMZ chemotherapy during the first course of GBM treatment.

ReferenceCitation: Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003. doi: 10.1056/NEJMoa043331.

ReferenceCitation: Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

lead_sponsor: Center Eugene Marquis

sponsor_collaborators:
Center Eugene Marquis
Rennes University Hospital

location_facility:
CHU de Bordeaux
CHU de Lyon
Center Eugene Marquis
CHU de Poitiers
CHRU de Lille
CHU La Timone
CHU de Grenoble
CHRU Hautepierre
CHU La Salpetriere
CHU Cote de Nacre


title: Phase I/II, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors

summary: This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.

lead_sponsor: Xenothera SAS

location_country: Belgium France

location_facility:
Hôpital Foch
Institut Jules Bordet
Centre Léon Bérard
IUCT-Oncopole


title: A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors

summary:
Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract.

Analysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore / improve the efficacy of immunotherapy in patients with NSCLC or RCC.

design_allocation: Non-Randomized

ReferenceCitation: Derosa L, Routy B, Thomas AM, Iebba V, Zalcman G, Friard S, Mazieres J, Audigier-Valette C, Moro-Sibilot D, Goldwasser F, Silva CAC, Terrisse S, Bonvalet M, Scherpereel A, Pegliasco H, Richard C, Ghiringhelli F, Elkrief A, Desilets A, Blanc-Durand F, Cumbo F, Blanco A, Boidot R, Chevrier S, Daillere R, Kroemer G, Alla L, Pons N, Le Chatelier E, Galleron N, Roume H, Dubuisson A, Bouchard N, Messaoudene M, Drubay D, Deutsch E, Barlesi F, Planchard D, Segata N, Martinez S, Zitvogel L, Soria JC, Besse B. Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer. Nat Med. 2022 Feb;28(2):315-324. doi: 10.1038/s41591-021-01655-5. Epub 2022 Feb 3.

ReferenceCitation: Derosa L, Routy B, Fidelle M, Iebba V, Alla L, Pasolli E, Segata N, Desnoyer A, Pietrantonio F, Ferrere G, Fahrner JE, Le Chatellier E, Pons N, Galleron N, Roume H, Duong CPM, Mondragon L, Iribarren K, Bonvalet M, Terrisse S, Rauber C, Goubet AG, Daillere R, Lemaitre F, Reni A, Casu B, Alou MT, Alves Costa Silva C, Raoult D, Fizazi K, Escudier B, Kroemer G, Albiges L, Zitvogel L. Gut Bacteria Composition Drives Primary Resistance to Cancer Immunotherapy in Renal Cell Carcinoma Patients. Eur Urol. 2020 Aug;78(2):195-206. doi: 10.1016/j.eururo.2020.04.044. Epub 2020 May 4.

lead_sponsor: EverImmune

location_facility: ICANS - Institut de cancérologie Strasbourg


title: Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation

acronym: QDA-UE

summary: The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.

primary_purpose: Diagnostic

lead_sponsor: Withings

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme


title: PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.

summary: PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf

ipd_sharing_description: Individual participant data that underlie the result that will be reported in an article and study protocol may be made available to researchers who provide a methodologically sound proposal, immediately after article publication and during 5 years

lead_sponsor: Womed

location_facility:
CHU Bicêtre
CHU Lariboisière
Hopital La Conception
Gent UZ


title: Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial

acronym: AERATE

summary: Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.

ReferenceCitation: Soumagne T, Guibert N, Atallah I, Lacasse Y, Dutau H, Fortin M. Dilation versus laser resection in subglottic stenosis: protocol for a prospective international multicentre randomised controlled trial (AERATE trial). BMJ Open. 2022 Mar 17;12(3):e053730. doi: 10.1136/bmjopen-2021-053730.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

lead_sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_country: Canada France

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: Hôpital Larrey, University Hospital of Toulouse

location_facility: Centre Hospitalier Universitaire Grenoble Alpes


title: A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

acronym: FASTR-AF

summary: The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

ReferenceCitation: Neuzil P, Poty H, de Chillou C, Petru J, Getman MK, Liu S, Funasako M, Durand-Dubief A, Combes S, Albenque JP. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol. 2023 Mar;66(2):343-351. doi: 10.1007/s10840-022-01234-9. Epub 2022 May 18.

publisher_dissemination: Springer-Nature

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Czechia France

location_facility:
Na Homolce
Clinique Pasteur
CHRU de Nancy
Clnique du Tonkin


lead_sponsor: Sanofi

summary:
Primary Objective:

Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL), and determine the recommended phase 2 dose (RP2D) for the subsequent Expansion part.
Expansion part: To assess the activity of single agent SAR440234 at the RP2D in participants with R/R AML or HR-MDS.

Secondary Objective:

To characterize the safety profile including cumulative adverse drug reactions.
To evaluate the potential immunogenicity of SAR440234.
To assess any preliminary evidence of hematologic response in the Dose Escalation Part.

ReferenceCitation: Gerard E, Zohar S, Thai HT, Lorenzato C, Riviere MK, Ursino M. Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics. Biometrics. 2022 Mar;78(1):300-312. doi: 10.1111/biom.13433. Epub 2021 Feb 18.

repository_institution: Cornell University - arXiv

repository_normalized: arXiv

repositories:
PubMed Central
arXiv

repositories_concat: PubMed Central;arXiv

publisher_dissemination: Wiley

location_facility:
Investigational Site Number 2500003
Investigational Site Number 2500001
Investigational Site Number 2500004
Investigational Site Number 8400001

status: Terminated

title: An Open-label, First-in-human, Dose Escalation Study of SAR440234 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), or High Risk Myelodysplasia (HR-MDS)

source: euctr

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
United States
France


title: A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.

acronym: TET-SEL

summary:
The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen.

This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients).

There are two study arms:

Arm A: Thymoma

Stage 1: 15 patients
Stage 2: 10 patients

Arm B: Thymic carcinoma

Stage 1: 15 patients
Stage 2: 10 patients

lead_sponsor: Morten Mau-Soerensen

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Denmark France

location_facility:
Intitut Gustave Roussy
Hospices Civils de Lyon
Rigshospitalet
Intitut Curie


title: A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain

summary: Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.

primary_purpose: Basic Science

location_facility:
CIC Clermont-Ferrand CHU G. Montpied
Institut Curie
Eurofins Optimed
ATC SA


title: IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.

acronym: IPS-II

summary:
Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.

Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.

lead_sponsor: Nuvaira, Inc.

location_country: Austria France

location_facility: Centre Hospitalier et Universitaire de Grenoble


lead_sponsor: Regeneron Pharmaceuticals

summary: The primary objective of the study is to assess the pharmacodynamic (PD) effect of alirocumab on serum low density lipoprotein cholesterol (LDL-C) during 14 weeks of subcutaneous (SC) administered alirocumab in patients with autosomal dominant hypercholesterolemia (ADH) and gain-of-function mutation (GOFm) in 1 or both alleles of the proprotein convertase subtilisin/kexin type 9 (PCSK9) gene or with loss-of-function mutation (LOFm) in 1 or more alleles of the apolipoprotein (ApoB) gene.

ReferenceCitation: Hopkins PN, Krempf M, Bruckert E, Donahue S, Yang F, Zhang Y, DiCioccio AT. Pharmacokinetic and pharmacodynamic assessment of alirocumab in patients with familial hypercholesterolemia associated with proprotein convertase subtilisin/kexin type 9 gain-of-function or apolipoprotein B loss-of-function mutations. J Clin Lipidol. 2019 Nov-Dec;13(6):970-978. doi: 10.1016/j.jacl.2019.10.007. Epub 2019 Oct 21.

ReferenceCitation: Hopkins PN, Defesche J, Fouchier SW, Bruckert E, Luc G, Cariou B, Sjouke B, Leren TP, Harada-Shiba M, Mabuchi H, Rabes JP, Carrie A, van Heyningen C, Carreau V, Farnier M, Teoh YP, Bourbon M, Kawashiri MA, Nohara A, Soran H, Marais AD, Tada H, Abifadel M, Boileau C, Chanu B, Katsuda S, Kishimoto I, Lambert G, Makino H, Miyamoto Y, Pichelin M, Yagi K, Yamagishi M, Zair Y, Mellis S, Yancopoulos GD, Stahl N, Mendoza J, Du Y, Hamon S, Krempf M, Swergold GD. Characterization of Autosomal Dominant Hypercholesterolemia Caused by PCSK9 Gain of Function Mutations and Its Specific Treatment With Alirocumab, a PCSK9 Monoclonal Antibody. Circ Cardiovasc Genet. 2015 Dec;8(6):823-31. doi: 10.1161/CIRCGENETICS.115.001129. Epub 2015 Sep 15.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

publisher_dissemination: Wolters Kluwer Health

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

title: A Phase 2 Pilot Study With a Randomized Double-Blind Treatment Phase to Evaluate the Pharmacodynamics and Safety of Alirocumab in Patients With Autosomal Dominant Hypercholesterolemia and Gain-of-Function Mutations in 1 or Both Alleles of the PCSK9 Gene or Loss-of-Function Mutations in 1 or More Alleles of the Loss-of-Function Mutations B Gene


title: An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom's Macroglobulinemia or Multiple Myeloma

summary: To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.

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.


title: Open Label Multi-Centric Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec (Imatinib)

acronym: ORACLE

summary: The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006, in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of the standard medication administered for these patients.

lead_sponsor: Bayer


title: A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

summary: The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

ReferenceCitation: Berg DD, Yeh RW, Mauri L, Morrow DA, Kereiakes DJ, Cutlip DE, Gao Q, Jarolim P, Michelson AD, Frelinger AL 3rd, Cange AL, Sabatine MS, O'Donoghue ML. Biomarkers of platelet activation and cardiovascular risk in the DAPT trial. J Thromb Thrombolysis. 2021 Apr;51(3):675-681. doi: 10.1007/s11239-020-02221-5.

evidence: open (via free pdf)

ReferenceCitation: Stefanescu Schmidt AC, Steg PG, Yeh RW, Kereiakes DJ, Tanguay JF, Hsieh WH, Massaro JM, Mauri L, Cutlip DE; DAPT Investigators. Interruption of Dual Antiplatelet Therapy Within Six Months After Coronary Stents (from the Dual Antiplatelet Therapy Study). Am J Cardiol. 2019 Dec 15;124(12):1813-1820. doi: 10.1016/j.amjcard.2019.09.006. Epub 2019 Sep 26.

ReferenceCitation: Berry NC, Kereiakes DJ, Yeh RW, Steg PG, Cutlip DE, Jacobs AK, Abbott JD, Hsieh WH, Massaro JM, Mauri L; DAPT Study Investigators. Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e005308. doi: 10.1161/CIRCINTERVENTIONS.117.005308.

ReferenceCitation: Yeh RW, Kereiakes DJ, Steg PG, Cutlip DE, Croce KJ, Massaro JM, Mauri L; DAPT Study Investigators. Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Oct 31;70(18):2213-2223. doi: 10.1016/j.jacc.2017.09.011.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Secemsky EA, Yeh RW, Kereiakes DJ, Cutlip DE, Cohen DJ, Steg PG, Cannon CP, Apruzzese PK, D'Agostino RB Sr, Massaro JM, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. JAMA Cardiol. 2017 May 1;2(5):478-487. doi: 10.1001/jamacardio.2017.0063.

publisher_dissemination: American Medical Association

ReferenceCitation: Stefanescu Schmidt AC, Kereiakes DJ, Cutlip DE, Yeh RW, D'Agostino RB Sr, Massaro JM, Hsieh WH, Mauri L; DAPT Investigators. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). Circulation. 2017 May 2;135(18):1720-1732. doi: 10.1161/CIRCULATIONAHA.116.024835. Epub 2017 Feb 22.

oa_colors: green other

ReferenceCitation: Resor CD, Nathan A, Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Gabriel Steg P, Hsieh WH, Mauri L; Dual Antiplatelet Therapy Study Investigators. Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation. 2016 Oct 4;134(14):989-998. doi: 10.1161/CIRCULATIONAHA.116.024531. Epub 2016 Aug 30.

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Steg PG, Wiviott SD, Mauri L; DAPT Study Investigators. DAPT Score Utility for Risk Prediction in Patients With or Without Previous Myocardial Infarction. J Am Coll Cardiol. 2016 May 31;67(21):2492-502. doi: 10.1016/j.jacc.2016.03.485. Epub 2016 Apr 1.

ReferenceCitation: Yeh RW, Secemsky EA, Kereiakes DJ, Normand SL, Gershlick AH, Cohen DJ, Spertus JA, Steg PG, Cutlip DE, Rinaldi MJ, Camenzind E, Wijns W, Apruzzese PK, Song Y, Massaro JM, Mauri L; DAPT Study Investigators. Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA. 2016 Apr 26;315(16):1735-49. doi: 10.1001/jama.2016.3775. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Meredith IT, Tanguay JF, Kereiakes DJ, Cutlip DE, Yeh RW, Garratt KN, Lee DP, Steg PG, Weaver WD, Holmes DR Jr, Brindis RG, Trebacz J, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Diabetes Mellitus and Prevention of Late Myocardial Infarction After Coronary Stenting in the Randomized Dual Antiplatelet Therapy Study. Circulation. 2016 May 3;133(18):1772-82. doi: 10.1161/CIRCULATIONAHA.115.016783. Epub 2016 Mar 18. Erratum In: Circulation. 2016 May 31;133(22):e671.

ReferenceCitation: Hermiller JB, Krucoff MW, Kereiakes DJ, Windecker S, Steg PG, Yeh RW, Cohen DJ, Cutlip DE, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. JACC Cardiovasc Interv. 2016 Jan 25;9(2):138-47. doi: 10.1016/j.jcin.2015.10.001.

ReferenceCitation: Mauri L, Elmariah S, Yeh RW, Cutlip DE, Steg PG, Windecker S, Wiviott SD, Cohen DJ, Massaro JM, D'Agostino RB Sr, Braunwald E, Kereiakes DJ; DAPT Study Investigators. Causes of late mortality with dual antiplatelet therapy after coronary stents. Eur Heart J. 2016 Jan 21;37(4):378-85. doi: 10.1093/eurheartj/ehv614. Epub 2015 Nov 18.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; DAPT Study Investigators. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. JACC Cardiovasc Interv. 2015 Oct;8(12):1552-62. doi: 10.1016/j.jcin.2015.05.026. Erratum In: JACC Cardiovasc Interv. 2015 Dec 21;8(14):1913.

ReferenceCitation: Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction. J Am Coll Cardiol. 2015 May 26;65(20):2211-21. doi: 10.1016/j.jacc.2015.03.003. Epub 2015 Mar 15.

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial. JAMA. 2015 Mar 17;313(11):1113-21. doi: 10.1001/jama.2015.1671. Erratum In: JAMA. 2015 Jun 2;313(21):2185. JAMA. 2016 Jul 5;316(1):105. JAMA. 2016 Jul 5;316(1):105.

repository_institution: University of Bern - Bern Open Repository and Information System

ReferenceCitation: Yeh RW, Czarny MJ, Normand SL, Kereiakes DJ, Holmes DR Jr, Brindis RG, Weaver WD, Rumsfeld JS, Roe MT, Kim S, Driscoll-Shempp P, Mauri L. Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):96-102. doi: 10.1161/CIRCOUTCOMES.114.001239. Epub 2014 Nov 16.

ReferenceCitation: Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.

ReferenceCitation: Matteau A, Yeh RW, Kereiakes D, Orav EJ, Massaro J, Steg PG, Normand SL, Cutlip DE, Mauri L. Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study). Am J Cardiol. 2014 Apr 1;113(7):1146-52. doi: 10.1016/j.amjcard.2013.10.015. Epub 2013 Nov 8.

ReferenceCitation: Mauri L, Kereiakes DJ, Normand SL, Wiviott SD, Cohen DJ, Holmes DR, Bangalore S, Cutlip DE, Pencina M, Massaro JM. Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions. Am Heart J. 2010 Dec;160(6):1035-41, 1041.e1. doi: 10.1016/j.ahj.2010.07.038.

sponsor_collaborators:
Baim Institute for Clinical Research
Abbott
Boston Scientific Corporation
Bristol-Myers Squibb
Sanofi-Synthelabo
Cordis Corporation
Eli Lilly and Company
Daiichi Sankyo, Inc.
Medtronic

location_country:
Germany
Poland
New Zealand
Hungary
United Kingdom
Romania
Australia
United States
Czechia
France

location_facility: Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S

location_facility: St. Luke's Hospital Mid America Heart Institute

location_facility: Donald Guthrie Foundation for Education and Research

location_facility: St. Vincent Hospital/ Providence Heart Hospital

location_facility: Northwest Indiana Cardiovascular Physicians, P.C.

location_facility: Heartland Education and Research Foundation

location_facility: Instytut Kardiologii im. Kardynala St. Wyszynskiego

location_facility: Frederick C Smith Clinic dba Smith Clinic

location_facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Oregon Health & Sciences University Hospital

location_facility: Black Hills Research- Rapid City Regional

location_facility: Uniwersyteck Szpital Klin. w Bialymstoku

location_facility: Institutul de Boli Cardiovasculare si Transplant Targu Mures

location_facility: Henry Ford Hospital Heart & Vascular Institute

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Bay Area Cardiology Associates/ Brandon Regional Hospital

location_facility: Great Lakes Heart & Vascular Institute, PC

location_facility: Capital Cardiovascular Research Institute

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont

location_facility: University of Oklahoma Health Sciences Center

location_facility: University Hospital of Leicester Glenfield Hospital

location_facility: Veteran's Affairs Medical Center- Dallas

location_facility: University of Arkansas (Central VA) for Medical Science

location_facility: Central Minnesota Heart Center at St. Cloud Hospital

location_facility: Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu

location_facility: Torrance Memorial Medical Center / Vasek Polak Research Program

location_facility: Universitaetsklinikum Schleswig-Holstein - PS

location_facility: St. Vincent Heart Center of Indiana, LLC

location_facility: Spitalul Clinic Universitar de Urgenta Bucuresti

location_facility: California Cardiovascular Consultants/ Washington Hospital

location_facility: UMDNJ - Robert Wood Johnson Medical School

location_facility: Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei

location_facility: The Foundation for Cardiovascular Medicine

location_facility: Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ

location_facility: Cardiovascular Associates of the Delaware Valley, PA

location_facility: Institutul Inimii Niculae Stancioiu Cluj-Napoca

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.

location_facility: Methodist DeBakey Heart & Vascular Center

location_facility: University Hospital of Coventry and Warwickshire


title: Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Two-part Clinical Study. PartA: Multisite MRI Acquisition, Protocol Harmonization. PartB: Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Clinical Study

summary:
THE STUDY WILL BE A TWO-PART RESEARCH

PART A and PART A extended:

To implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners).
Apply the common MRI protocol on phantoms and human subjects to characterize, compare and minimize test-retest variability across the MR sites of WP5 for all the quantitative metrics that will be later assessed on patients.

PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and neurophysiological data in Mild Cognitive Impairment patient, we aim to:

To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) which is more sensitive than the changes observed in the loss of hippocampal volume (primary endpoint) and correlate with the neuropsychological progression and conversion (clinical secondary endpoints).
To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) at baseline which is more predictive of the loss of hippocampal volume (primary endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI patients.
To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe

ReferenceCitation: Grady CL, Haxby JV, Horwitz B, Sundaram M, Berg G, Schapiro M, Friedland RP, Rapoport SI. Longitudinal study of the early neuropsychological and cerebral metabolic changes in dementia of the Alzheimer type. J Clin Exp Neuropsychol. 1988 Oct;10(5):576-96. doi: 10.1080/01688638808402796.

lead_sponsor: Qualissima

sponsor_collaborators:
Qualissima
European Union

location_country: Germany Italy Netherlands Spain Greece France

location_facility: Università Cattolica del Sacro Cuore - Policlinico Agostino Gemelli Istituto di Neurologia - Neuropsychological and Neurorehabilitation Unit

location_facility: IRCCS-FBF - Ordine Ospedaliero San Giovanni di Dio, Fatebenefratelli, Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Institut d'Investigacions Biomèdiques August Pi I Sunyer, IDIBAPS

location_facility: Neurofisiologia Clinica IRCCS Azienda Ospedaliera Universitaria San Martino-IST, Padiglione Specialita' piano Fondi

location_facility: University Hospital of Leipzig - Department of Psychiatry

location_facility: IRCCS Fondazione SDN per la Ricerca e l'Alta Formazione in Diagnostica Nucleare di Napoli

location_facility: Dipartimento di Specialità medico-chirurgiche e Sanità Pubblica, Sezione di Clinica Neurologica, Centro Disturbi della Memoria, Perugia, Italy

location_facility: Hospital and Institute of the University of Duisburg and Essen - Department for Psychiatry and Psychotherapy, LVR Hospital Essen

location_facility: Université Lille 2, UL2 - Centre d'investigation clinique / Centre de Ressources biologiques 9301 - INSERM - Centre Hospitalier Régional et Universitaire de LILLE

location_facility: Aristotle University of Thessaloniki, Greek Association of Alzheimer's disease and related disorders, Thessaloniki, Greece

location_facility: APHM, Hopital de la Timone, Service de Neurologie et Neuropsychologie


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)

summary: The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Germany
Italy
Poland
Israel
Australia
United States
Spain
Czechia
Ukraine
Bulgaria
Canada
France

location_facility:
Valencia
Zaporozhya
Warsaw
Lodz
Petah Tiqva
Poliklinika, Chocen,
Duesseldorf,
Houston, Texas
Pheonix, Arizona
Tampa, Florida
Haag in Oberbayern
Ramat Gan
Erina, New South Wales
Toledo, Ohio
Barcelona
Stadtroda
Medical center VITA1, Pleven
Adventura, Florida
Las Vegas, Nevada
Reseda, California
United States, Washington
Englewood, Colorado
Milano
Bad Homburg
Los Angeles, California
Haifa
Sofia
Rome
Woolloongabba, Queensland
Springub
Columbus, Ohio
Atlantis, Florida
Creteil
Nancy, France
Lexington, Kentucky
Kraków
Shoham
Ottawa, Ontario
Padova
Prague,
Canada, Ville De Quebec
Muenster
Savannah, Georgia
Chicago, Illinois
Parkville, Victoria
Madrid, Spain
Raleigh, North Carolina
Asheville, North Carolina
Winfield, Illinois
Burlington, Vermont
Farmington Hills, Michigan
Lublin
Terrassa
Toronto, Ontario
Pleven, Bulgaria
Durham, North Carolina
Rychnov nad Kněžnou
Sevilla
Boca Raton, Florida
Lubbock, Texas
Jerusalem
Ormond Beach, Florida
Multiprofile Hospital, Sofia
Birmingham, Alabama
Katowice
Little Rock, Arkansas
Elche
Boulevard Pinel, Bron
Dnipro
Zaporiizhzhya
Virginia Beach, Virginia
Kharkiv
Kansas City, Kansas
Fountain Valley, California
Scarborough, Maine
Boston, Massachusetts
Denver, Colorado
Singua
Philadelphia, Pennsylvania
Augusta, Georgia
Nîmes cedex
Pasadena, California
Ashkelon
East Lansing, Michigan
DCC Neoclinic
Dayton, Ohio
Georgetown, Texas
Pisa
Grenoble cedex
Madrid
Tel Aviv
Pleven


title: Unruptured Cerebral Aneurysm: Prediction of Evolution

acronym: U-CAN

summary: The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Centre Hospitalier St Anne

location_country: Netherlands Switzerland France

location_facility:
Reims University Hospital
Nantes University Hospital
Rostchild Foundation Hospital
AP-HP La Pitié-Salpêtrière Hospital
Clairval's Hospital
Nancy University Hospital
Toulouse University Hospital
Ste Anne's Hospital
Amiens University Hospital
Creteil University Hospital
Tours University Hospital
UMC Utrecht
Rouen University Hospital
Brest University Hospital
Rennes University Hospital
Bordeaux University Hospital
InselHospital Bern
Limoges University Hospital
AP-HP Le Kremlin Bicêtre Hospital
Angers University Hospital

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: UCAN

titre: Anévrisme cérébral non rompu : prédiction de l'évolution

discipline_principale: médecine vasculaire

nom_porteur: Bourcier

prenom_porteur: Romain


title: ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).

summary: This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.

primary_purpose: Supportive Care

ReferenceCitation: Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guerin C, Dellamonica J, Jaber S, Brochard L, Similowski T. Neurally adjusted ventilatory assist as an alternative to pressure support ventilation in adults: a French multicentre randomized trial. Intensive Care Med. 2016 Nov;42(11):1723-1732. doi: 10.1007/s00134-016-4447-8. Epub 2016 Sep 30.

repositories_concat: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

lead_sponsor: Clinact

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque

location_facility: Hopital de la Cote de Nacre - CHU de CAEN


title: Transcatheter Patent Foramen Ovale (PFO) Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Between 60 and 80 Years Old : a Randomised Controlled Trial.

summary: To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
W.L.Gore & Associates
Abbott
Occlutech International AB
Centre Hospitalier St Anne

location_facility:
CHU Bordeaux - GH Pellegrin
CH Arras
CHRU La Cavale Blanche
CHU Rouen-Hôpital Charles-Nicolle
CHU Saint-Etienne-Hôpital Nord
CHU Jean Minjoz
CHU Amiens
Hôpital Gui de Chauliac
Hôpital Pitié Salpêtrière
CH Perpignan
CHU Carémeau
Hôpital de la Timone
APHP Hôpital Bichat
CHU Nantes-Hôpital Nord Laennec
CHU Bicêtre
CHU Toulouse-Hôpital Pierre Paul Riquet
CHU Côte de Nacre
CHU Dijon-Hôpital François Mitterrand
Fondation Adolphe de Rothschild
GHU Paris Psychiatrie et Neurosciences
CH Versailles-Hôpital Mignot
CHRU Lille-Hôpital Salengro
Hôpital Henri Mondor
CHRU Nancy-Hôpital central
CHU La Milétrie
CH Yves Le Foll
APHP Hôpital Lariboisière
HCL-Groupement Hospitalier Lyon Est
CH Grenoble-Site Nord
Groupe Hospitalier Paris Saint-Joseph
Hôpital Hautepierre


title: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

acronym: BRUIN CLL-322

summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

lead_sponsor: Loxo Oncology, Inc.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_country:
Germany
Ireland
Poland
Australia
Japan
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC)

location_facility: University of California Irvine Medical Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS

location_facility: The Ohio State University Wexner Medical Center

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: CIUSSS du Centre Ouest de l'lle de Montreal

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: American Oncology Partners of Maryland, PA

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Guangxi Medical University Cancer Hospital

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Novant Health Cancer Institute - Charlotte

location_facility: Shengjing Hospital of China Medical University

location_facility: Health Corporation of Galilee Medical Center

location_facility: Tongji Hospital Affiliated to Tongji Medicine University

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

location_facility: Houston Methodist Hospital Cancer Center

location_facility: The First People's Hospital of Yunnan Province

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: The First Affiliated Hospital Of University Of South China

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Hospital Universitario Central de Asturias

location_facility: Union Hospital,Tongji Medical College, Huazhong University of Science and Technology

location_facility: CHU de Nancy - Hôpital de Brabois Adultes

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: The Second Xiangya Hospital of Central South University

location_facility: The Catholic University of Korea-Seoul St. Mary's Hospital

location_facility: Azienda Ospedaliera di Catanzaro "Pugliese-Ciaccio"

location_facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Institut Universitaire du Cancer de Toulouse- IUCT-O

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Hospital Universitario Fundación Jiménez Díaz


title: Safety of a Management Strategy Based on Colour Doppler ULTrasound and D-Dimer Testing for the Diagnosis Exclusion of RECurrent Deep Vein Thrombosis of the Lower Limbs. The ULTREC Project

acronym: ULTREC

summary:
The purpose is to assess the safety of a management strategy based on colour doppler ultrasound (CDUS) and D-Dimer test results for the diagnosis exclusion of recurrent deep vein thrombosis (DVT) of the lower limbs.

DVT recurrence requires using anticoagulant treatment to prevent thrombosis progression. Given an increased bleeding risk with prolonged treatment, an accurate diagnosis for recurrence is needed. However, the diagnosis of a new thrombosis in a previously involved leg is difficult. Imaging modalities and criteria that are currently used for the diagnosis may be equivocal and unable to discriminate between an old clot and a new one recently developed at the same site. An increase in vein diameter after vein compression by the ultrasound probe was suggested as a diagnostic criterion for a new DVT. This method has many limitations in clinical practice, mainly a lack of availability of a previous measurement and a poor inter-observer agreement.

Colour Doppler ultrasound enables to study both the thrombus and the blood flow characteristics that might help to overcome these limitations. CDUS is a well-known method for the diagnosis of vascular diseases and is used in every day clinical practice for the diagnosis of a first DVT and DVT recurrence but CDUS has never been assessed for DVT recurrence in a study. The diagnosis of DVT recurrence may be easily established using the same criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely rule out the diagnosis of DVT recurrence while maintaining a good specificity.

The strategy consists in performing first a CDUS that helps to classify patients as having (positive CDUS) or not having (negative CDUS) a new thrombosis. In the case of an equivocal CDUS, a D-Dimer test is performed. If the D-dimer is normal, the diagnosis of DVT recurrence is ruled out and the patient is not treated. If the D-dimer is abnormal, the diagnosis cannot be excluded nor confirmed and a second CDUS is performed on D7±2. Meanwhile, patients are not treated by anticoagulants. An unchanged CDUS on D7±2 qualifies patients as free from a new DVT and they are not treated. Conversely a change in CDUS qualifies patients as having a new DVT which requires anticoagulant treatment.

All patients have a 3-month follow-up for the assessment of potential venous thromboembolic events.

ReferenceCitation: Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.

ReferenceCitation: Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4. doi: 10.1002/ajh.20754.

ReferenceCitation: Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.

ReferenceCitation: Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98. doi: 10.7326/0003-4819-136-2-200201150-00006.

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lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

collaborators: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Investigation network on venous thrombo-embolism

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre de medicine vasculaire interventionnel

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Universitaire Rangueil

location_facility: Cabinet libéral Besancon - polyclinique des Fleurs

location_facility: Centre Hospitalier Universitaire François Mitterrand

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre hospitalier Universitaire Cavale Blanche

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire d'Amiens

region: Provence-Alpes-Côte d'Azur

nom_etablissement: CHI TOULON LA SEYNE SUR MER

acronyme: ULTREC

titre: Sécurité d'une stratégie basée sur les ultrasons et les D-dimères pour l'exclusion du diagnostic de récidive de thrombose veineuse profonde (TVP) des membres inférieurs (Projet ULTREC)

nom_porteur: Elias

prenom_porteur: Antoine