title: TRI-FR : Multicentric Randomized Evaluation of Tricuspid Valve Percutaneous Repair System (Clip for the Tricuspid Valve) in the Treatment of Severe Secondary Tricuspid Disorders

acronym: TRI-FR

summary:
Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population. It is often a consequence of chronic left cardiac pathologies or atrial fibrillation. Surgical treatment is recommended in severe symptomatic TR or when the tricuspid annulus is dilated with TR identified prior to scheduled left heart valve surgery. TR are mainly secondary (complicating left heart disease, pulmonary hypertension, atrial fibrillation and atrial dilatation) and pose a difficult problem related to the prognosis. The risk of death or hospitalization is high under medical treatment. Nevertheless, the surgical results are disappointing with significant morbidity and mortality, which are increased by associated comorbidities that are frequent in these sorts of patients. The benefit-risk assessment of surgery is limited by multiple confounders.

This justifies the evaluation of alternative methods aimed at correcting TR with less interventional risk.

The Clip for the tricuspid valve has been evaluated in the TRILUMINATE trial (inclusion of 85 patients with moderate-to-severe symptomatic TR with a 6-month follow-up). The Triclip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post-procedure. It justified the European Conformity (CE) mark obtention.

A very similar system for the mitral valve (Mitraclip) was previously tested in the randomized EVEREST II study against conventional surgery. The results of the EVEREST II trial justified the recourse to percutaneous edge-to edge mitral repair in patients with primary mitral regurgitation when the patient is contraindicated to conventional surgery.

The Mitra-FR study made it possible to study the role of Mitraclip for treating patient suffering from a secondary mitral insufficiency. It leads to the implementation of this technique in selected patients.

For secondary TR, several series underscored its prevalence and its clinical consequences. TR treatment justifies the proposal for a randomized study. As a matter of fact, evidence for treating are seriously lacking. Surgical surveys report hospital mortality ~ 8.8%. It, therefore, seems necessary to conduct a study as robust as possible to evaluate the contribution of clip for the tricuspid valve (as an innovative percutaneous technique) compared to conventional pharmacological treatment in patients who are unsuitable for a surgical isolated correction of the TR and who has suitable anatomy for clip for the tricuspid valve. It will be necessary to demonstrate clinical, functional (quality of life), echocardiographic and biological benefit of the percutaneous treatment vs optimized medical treatment alone.

ReferenceCitation: Donal E, Leurent G, Iung B. Are We Right to Believe in the Value of Transcatheter Treatment of Secondary Tricuspid Regurgitation? J Am Coll Cardiol. 2021 Jan 26;77(3):240-242. doi: 10.1016/j.jacc.2020.11.037.

lead_sponsor: Rennes University Hospital

location_country: France Belgium

location_facility: CHU Bordeaux - Hôpital Cardiologique du Haut-Lévêque

location_facility: CHU Nantes - Hôtel Dieu et Hôpital Nord Laennec

location_facility: Hospices Civils de Lyon Groupement Hospitalier EST

location_facility: Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier


status: Recruiting

primary_purpose: Treatment

acronym: SOREGATT

intervention_type: Drug

title: A Randomized, Phase II Study Comparing the Sequences of Regorafenib and Trifluridine/Tipiracil, After Failure of Standard Therapies in Patients With Metastatic Colorectal Cancer

study_completion_date_type: Anticipated

lead_sponsor: UNICANCER

type: EudraCT Number

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Anticipated

location_facility: Association Hôpital Saint Joseph de Marseille

location_facility: Hôpital Privé des Côtes d'Armor - Centre CARIO-HPCA

location_facility: APHP - Hôpital Européen Georges Pompidou

summary: A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Evaluation of the Impact of the Update Multiple Myeloma Criteria on the Natural History of Smoldering Myeloma in Order to Establish New Recommendations About Follow-up and Prognostic Evaluation of Smoldering Myeloma (CARRISMM)

acronym: CARRISMM

summary: This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.

primary_purpose: Screening

ipd_sharing: No

lead_sponsor: Intergroupe Francophone du Myelome

location_country: France Monaco Belgium

location_facility: Centre de Recherche Clinique / GHT des Landes

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier de Quimper Cornouaille

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Institut Bergonié - Pavillon Saint Genès - 1er étage

location_facility: CHV André Mignot - Université de Versailles

location_facility: CHRU Hôpital Bretonneau - Centre Henry Kaplan

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: CHU Carémeau, Institut de Cancérologie du Guard

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: CH Bretagne Atlantique Vannes et Auray - P. Chubert

intervention_type: Procedure


title: Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study

acronym: NURSIE

summary:
Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.

Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..)

Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: French Society for Intensive Care

location_country: France Switzerland Luxembourg Belgium

location_facility:
CHU Besançon
Hopital Civil Marie Curie
CH Andre Migniot
CHU Strasbourg
Hopital de Bruxelles
CHU Toulouse
CH Sud Francilien
CHU Marseille
CHU Necker Enfant Malade
Hopital Jeanne De Flandre
CHU Ambroise Paré
CHU Nice
CHU La Pitié Salpétrière
Hopital Europeen George Pompidou
CHRU Lille
CH de la Dracénie
Centre Hospitalier Emile Mayrisch
CHR Orléans
CH de Dax
CHI Lucie & Raymond Aubrac
CHU Nimes
CHU Nantes
Hopital de la Tour
CHU Charleroi
CHU Lariboisière
CH Valence

status_simplified: Completed


title: A Multicentre, Phase II, Open Label, Single Arm Study of Pixantrone in Patients With CD20-positive Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma Treated With Rituximab, Ifosfamide and Etoposide.

summary: This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut Jules Bordet - Centre des tumeurs de l'ULB

intervention_type: Other


title: A Prospective, Non-interventional, Multinational Study Evaluating the Efficacy and the Safety of High Dose Therapy Followed by Autologous Hematopoietic Stem Cell Transplantation as a Frontline Therapy for Myeloma Patients With Severe Renal Impairment (IRMYG Study)

acronym: IRMYG

summary: Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is recommended when at least one of the myeloma defining events occurs (CRAB features). Renal impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM patients at diagnosis and 40-50% of patients during the course of their disease. To date, there is no defined consensus for the management of myeloma patients with renal failure. It is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country: Lebanon Algeria France Belgium

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire d'Amiens

lead_sponsor_type: academique


title: A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP

acronym: Epi-RCHOP

summary:
Phase I of the study is designed to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with 8 cycles of R-CHOP 21.

Phase II of the study is designed to determine the safety and the efficacy of tazemetostat in DLBCL and FL patients :

DLBCL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab FL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab then maintenance with 6 months of tazemetostat and 24 months of Rituximab

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Sarkozy C, Morschhauser F, Dubois S, Molina T, Michot JM, Cullières-Dartigues P, Suttle B, Karlin L, Le Gouill S, Picquenot JM, Dubois R, Tilly H, Herbaux C, Jardin F, Salles G, Ribrag V. A LYSA Phase Ib Study of Tazemetostat (EPZ-6438) plus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) with Poor Prognosis Features. Clin Cancer Res. 2020 Jul 1;26(13):3145-3153. doi: 10.1158/1078-0432.CCR-19-3741. Epub 2020 Mar 2.

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry

acronym: SOURCE 3

summary:
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.

300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.

ReferenceCitation: Tarantini G, Nai Fovino L, Le Prince P, Darremont O, Urena M, Bartorelli AL, Vincent F, Hovorka T, Alcalá Navarro Y, Dumonteil N, Ohlmann P, Wendler O. Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve. Circ Cardiovasc Interv. 2020 Jul;13(7):e008972. doi: 10.1161/CIRCINTERVENTIONS.120.008972. Epub 2020 Jun 25.

ReferenceCitation: Fernandez-Santos S, Théron A, Pibarot P, Collart F, Gilard M, Urena M, Hovorka T, Kahlert P, Zamorano Gomez JL. Valve hemodynamic performance and myocardial strain after implantation of a third-generation, balloon-expandable, transcatheter aortic valve. Cardiol J. 2020;27(6):789-796. doi: 10.5603/CJ.a2019.0049. Epub 2019 May 20.

ReferenceCitation: Tarantini G, Lefèvre T, Terkelsen CJ, Frerker C, Ohlmann P, Mojoli M, Eltchaninoff H, Pinaud F, Redwood S, Windecker S. One-Year Outcomes of a European Transcatheter Aortic Valve Implantation Cohort According to Surgical Risk. Circ Cardiovasc Interv. 2019 Jan;12(1):e006724. doi: 10.1161/CIRCINTERVENTIONS.118.006724.

ReferenceCitation: Frank D, Abdel-Wahab M, Gilard M, Digne F, Souteyrand G, Caussin C, Collart F, Letocart V, Wöhrle J, Kuhn C, Hovorka T, Baumgartner H. Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry. Clin Res Cardiol. 2019 Jul;108(7):763-771. doi: 10.1007/s00392-018-1404-2. Epub 2018 Dec 14.

ReferenceCitation: Wendler O, Schymik G, Treede H, Baumgartner H, Dumonteil N, Neumann FJ, Tarantini G, Zamorano JL, Vahanian A. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve. Eur Heart J. 2017 Sep 21;38(36):2717-2726. doi: 10.1093/eurheartj/ehx294.

lead_sponsor: Edwards Lifesciences

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Finland
Switzerland
France
Germany
Slovakia

location_facility: Narodny ustav srdcovych a cievnych chorob, a. s.

location_facility: Evangelisches Klinikum Niederrhein Herzzentrum Duisburg

location_facility: Centre Chirurgical Marie Lannelongue - Le Plessis-Robinson

location_facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen

location_facility: Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG

location_facility: Institut Hospitalier Jacques Cartier Massy

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Azienda A.R.N.A.S. Ospedale Civico di Palermo

location_facility: Centre Cardiologique du Nord - Saint-Denis

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Staedtisches Klinikum Karlsruhe GmbH (SKK)

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

intervention_type: Device


title: EWOC-1 Trial: Multicenter, Randomized Trial of Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer

summary:
The current standard of first-line chemotherapy in advanced ovarian cancer is the combination of carboplatin AUC 5mg/mL/min and paclitaxel 175 mg.m-². This combination is feasible in selected elderly patients such as those included in prospective trials. These trials, however, include a minority of the elderly population. In wider selection of patients >70 years old, the standard carboplatin-paclitaxel regimen has been shown to induce an excess of toxicity and premature treatment stopping. For elderly patients thought to be vulnerable and at high risk of toxicity with the standard 3-weekly carboplatin-paclitaxel regimen, other options are used in routine practice. One option is to delete paclitaxel and treat elderly patients with carboplatin as a single agent. An alternative is to use the carboplatin-paclitaxel regimen in a weekly schedule for both drugs such as reported by the MITO (Multicentre Italian Trial in Ovarian Cancer).

To date, there is no randomized trial which could give us some evidence of how to select patients who could benefit most of one or the other regimen described above. The 4th Ovarian Cancer Consensus Conference has indeed recognised the medical unmet need of adapted therapy for elderly patients with ovarian cancer and the necessity of additional research in this population.

Recently, GINECO has described a Geriatric Vulnerability Score (GVS) in a population of elderly patients with advanced ovarian cancer included in a specific multicenter phase II trial. The best proportional hazard model fitting for overall survival identified the following geriatric covariates score as being poor survival risk factors: ADL score <6, IADL score <25, HADS score >14, albuminemia <35g/L and , lymphopenia <1G/L. GVS is the sum of these risk factors for each patient. Using a cut off of 3, the GVS identified a group of patients at high risk of severe toxicity, early cessation of treatment, unplanned hospitalization and adverse outcomes.

This international multicentre randomized phase II trial will compare the success rate of delivering 6 courses of chemotherapy with evidence of efficacy and without premature termination for progression, death or unacceptable toxicity of three different chemotherapy regimens in a selected population of elderly patients with a GVS ≥ 3:

Arm A: Paclitaxel 175mg/m²/3 hours, I.V. and carboplatin AUC 5, I.V. every 3 weeks
Arm B: Carboplatin monotherapy AUC 5 or 6 every 3 weeks
Arm C: Weekly paclitaxel 60 mg/m²/1 hour and weekly carboplatin AUC 2 (d1, d8, d15 every 4 weeks)

The total number of patients to be enrolled is 240, ie 22 in each arm (total = 66) at the first step, then 58 more by arm (total=174) after interim analysis.

ReferenceCitation: Falandry C, Rousseau F, Mouret-Reynier MA, Tinquaut F, Lorusso D, Herrstedt J, Savoye AM, Stefani L, Bourbouloux E, Sverdlin R, D'Hondt V, Lortholary A, Brachet PE, Zannetti A, Malaurie E, Venat-Bouvet L, Trédan O, Mourey L, Pujade-Lauraine E, Freyer G; Groupe d'Investigateurs Nationaux pour l'Étude des Cancers de l'Ovaire et du sein (GINECO). Efficacy and Safety of First-line Single-Agent Carboplatin vs Carboplatin Plus Paclitaxel for Vulnerable Older Adult Women With Ovarian Cancer: A GINECO/GCIG Randomized Clinical Trial. JAMA Oncol. 2021 Jun 1;7(6):853-861. doi: 10.1001/jamaoncol.2021.0696. Erratum in: JAMA Oncol. 2021 Jun 1;7(6):945.

lead_sponsor: Hospices Civils de Lyon

location_country: Denmark Italy Finland Canada France Sweden

location_facility: Service d'Oncologie Médicale - Centre Hospitalier d'Alès

location_facility: Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan

location_facility: Service d'Oncologie Médicale - Centre Paul Strauss

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Servide d'Oncologie Médicale - Institut Jean Godinot

location_facility: Service d'Oncologie Médicale - Centre Georges François Leclerc

location_facility: Service d'Oncologie - Centre Hospitalier Alpes Leman

location_facility: Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap

location_facility: Service de Médecine Interne et Oncologie Médicale - CH du Mans

location_facility: Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc

location_facility: Service d'Oncologie Service 2 B Nord - Centre Léon Bérard

location_facility: Service d'Oncologie Médicale - Institut Bergonié

location_facility: Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine

location_facility: Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans

location_facility: Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou

location_facility: Service d'Oncologie Radiothérapie - Clinique de Valdegour

location_facility: Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble

location_facility: Servide d'Oncologie Médicale - Hôpital Jean Minjoz

location_facility: Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo

location_facility: Service d'Oncologie - Centre Hospitalier de Chambéry

location_facility: Service d'Onco-Hématologie - Hôpital Fleyriat

location_facility: service d'Oncologie Médicale - Centre Hospitalier Broussais

location_facility: Service d'Oncologie Médicale - ICO Centre René Gauducheau

location_facility: Service d'Oncologie - Groupe Hospitalier Saint-Joseph

location_facility: Service d''Hématologie Oncologie - Hôpital André Mignot

location_facility: Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo

location_facility: Service d'Oncologie Médicale - Centre Azuréen de Cancérologie

location_facility: Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin

location_facility: Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle

location_facility: Service d'Uro-Gynécologie - Centre François Baclesse

location_facility: Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil

location_facility: Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman

location_facility: Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy

location_facility: Service d'Onco-Hématologie - Centre Antoine Lacassagne

location_facility: Service d'Oncologie Médicale - Centre Hospitalier de Perpignan

location_facility: Service d'Oncologie Médicale - ICO Paul Papin

location_facility: Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy

location_facility: Service de cancérologie clinique - Institut Sainte-Catherine

location_facility: Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire

location_facility: Service de Chimiothérapie - Centre Catherine de Sienne

location_facility: Service d'Oncologie Médicale - Institut Claudius Regaud

location_facility: Service d'Oncologie multidisciplinaire - Hôpital Nord

location_facility: Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll

location_facility: Centro di Riferimento Oncologico - CRO,IRCCS

location_facility: Service d'Oncologie Médicale - Institut Paoli Calmettes

location_facility: Service d'Oncologie Médicale - Centre Hospitalier de Cholet

location_facility: Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis

location_facility: Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire

location_facility: Centre CARIO - Hôpital Privé des Côtes d'Armor

location_facility: Service d'Oncologie Médicale - Hôpital des Diaconesses

location_facility: Servide d'Oncologie Médicale - Centre Jean Perrin

location_facility: Service d'Oncologie Médicale - Centre Hospitalier de Sens

location_facility: Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille


title: STUDY OF THE EFFICACY AND SAFETY OF FIRST LINE TREATMENT WITH CHOP AND LENALIDOMIDE (Rev-CHOP) IN PATIENTS AGED FROM 60 TO 80 YEARS WITH PREVIOUSLY UNTREATED ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL)

summary: This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient.

ReferenceCitation: Lemonnier F, Safar V, Beldi-Ferchiou A, Cottereau AS, Bachy E, Cartron G, Fataccioli V, Pelletier L, Robe C, Letourneau A, Missiaglia E, Fourati S, Moles-Moreau MP, Delmer A, Bouabdallah R, Voillat L, Becker S, Bossard C, Parrens M, Casasnovas O, Cacheux V, Régny C, Camus V, Delfau-Larue MH, Meignan M, de Leval L, Gaulard P, Haioun C. Integrative analysis of a phase 2 trial combining lenalidomide with CHOP in angioimmunoblastic T-cell lymphoma. Blood Adv. 2021 Jan 26;5(2):539-548. doi: 10.1182/bloodadvances.2020003081.

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Centre hospitalier Chalon sur Saone William Morey

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Université Catholique de Louvain Saint Luc


title: Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer

summary: The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.

lead_sponsor: Coloplast A/S

location_country: Denmark France

location_facility:
Centre Hospitalier
HIA Sainte Anne
CHRU La Miletrie
Hôpital jacques Monod
CHIVA
CH
Arhus Sygehus
CHD Les Oudairies
CH Cornouailles
Cabilet Medical
Hôpital Corention Celton
Hôpital Manchester
CHU
Centre Hospitalier de Douai
Centre hospitalier intercommunal
Hôpital de Saint Gaudens
Cabinet Medical
Cabinet Médical
Clinique Pasteur
Hôpital Dupuytren
Odense Universitets Hospital
CHU Sud
Bispebjerg ^Hospital
Hôpital de Freyming
CHRU Tours
Clinique Mathilde
CH Le Mans
CHU Caremeau
Hôpital lariboisiere


title: CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial

summary:
Background: Two recent systematic reviews of the literature and meta-analyses have suggested that colloids administration might be deleterious in critically ill patients.

Objective: To compare the effects on hospital mortality of crystalloids and colloids when given for fluid resuscitation in critically ill patients.

Setting: Adult intensive care units (ICUs) in several European countries.

Study design: A multinational, randomised, controlled trial performed on two parallel groups.

Intervention: Any type of crystalloids (control group) versus any type of colloids (including albumin).

Patients: All patients above the legal age of consent and hospitalised in an intensive care unit, who need fluid resuscitation (according to the physician). Pregnant women, moribund patients, brain dead patients, and patients who have a known allergy to colloids or severe head injury or major burns (> 20% of body surface) or dehydration will not be included.

Primary endpoint: 28-day mortality.

Hypothesis: Assuming a hospital mortality rate of 20% in the crystalloids group, a 0.05 type I error, 3010 patients are needed to show a difference between the 2 groups of 5% with a 90% probability (two-sided test).

ReferenceType: result

ReferenceCitation: Annane D, Siami S, Jaber S, Martin C, Elatrous S, Declère AD, Preiser JC, Outin H, Troché G, Charpentier C, Trouillet JL, Kimmoun A, Forceville X, Darmon M, Lesur O, Reignier J, Abroug F, Berger P, Clec'h C, Cousson J, Thibault L, Chevret S; CRISTAL Investigators. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013 Nov 6;310(17):1809-17. doi: 10.1001/jama.2013.280502. Erratum in: JAMA. 2013 Mar 12;311(10):1071. Régnier, Jean [corrected to Reignier, Jean]; Cle'h, Christophe [corrected to Clec'h, Christophe].

ReferenceCitation: Heming N, Elatrous S, Jaber S, Dumenil AS, Cousson J, Forceville X, Kimmoun A, Trouillet JL, Fichet J, Anguel N, Darmon M, Martin C, Chevret S, Annane D; CRISTAL Investigators. Haemodynamic response to crystalloids or colloids in shock: an exploratory subgroup analysis of a randomised controlled trial. BMJ Open. 2017 Oct 6;7(10):e016736. doi: 10.1136/bmjopen-2017-016736.

lead_sponsor: University of Versailles

location_country:
United Kingdom
Canada
Tunisia
France
Belgium

location_facility:
Hôpital Cavale Blanche
Hôpital Erasme
HIA Percy
Hôpital Bicêtre
Chu Bourguiba
CHG Valence
Chu Lyon Sud
CHU de Sherbrooke-Höpital Fleurimont
CHU Toulouse
Centre Hospitalier de Mulhouse
Hôpital Bichat Claude Bernard
Hôtel Dieu
Hôpital Civil
Polyclinique de Gentilly
Hôpital T Sfar
Hôpital Avicenne
CH Joseph Imbert
Hôpital A Mami
Hôpital Hautepierre
CH Dupuytren
Centre Hospitalier d'Annecy
CHU Rennes
Hôpital Charles Nicolle
CHG de Bastia
Chu Reims
CHI Saint Germain en Laye
Centre Hospitalier d'Etampes
Hôpital Claude Huriez
Hôpital Central
CH Claude Galien
Centre Hospitalier R. Dubos
Hôpital la Pitié Salpétrière
Homerton University Hospital
Hôpital Louis Pradel
HEGP
CH Dourdan
Centre Cardiologique du Nord
CH Victor Provo
Hôpital Saint Louis
Hôpital TENON
CHG de SOISSONS
CH Pellegrin Tripode
Hôpital Général
Hôpital de FREYMING-MERLEBACH
CHRG d'Orléans
CHR
CH d'Arpajon
CHU Liege
CH MEAUX
Hôpital Central NANCY
Hôpital Lariboisière
CH d'Angers
CHU de Bordeaux
CHI Poissy
CH Mémorial SAINT LO
CHR Bel Air
Hôpital Corbeil Essonnes
CHU Brabois Nancy
Hôpital A. Beclere
Hôpital Raymond Poincaré
Hôpital A. Mignot
Chg Briancon
CHU de Poitiers
Hôpital Saint Eloi
Centre Régional Léon Bernard
Hôpital Henri Mondor
Hôpital Charles LeMoyne


title: Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2

summary: The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Rubio MT, Bouillié M, Bouazza N, Coman T, Trebeden-Nègre H, Gomez A, Suarez F, Sibon D, Brignier A, Paubelle E, Nguyen-Khoc S, Cavazzana M, Lantz O, Mohty M, Urien S, Hermine O. Pre-transplant donor CD4(-) invariant NKT cell expansion capacity predicts the occurrence of acute graft-versus-host disease. Leukemia. 2017 Apr;31(4):903-912. doi: 10.1038/leu.2016.281. Epub 2016 Oct 14.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Germany France Belgium

location_facility: Institut Universitaire du Cancer de Toulouse

intervention_type: Diagnostic Test


summary: The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.

primary_purpose: Supportive Care

lead_sponsor: Pierre Fabre Medicament


title: Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

summary:
The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism.

The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.

ReferenceCitation: Kraaijpoel N, Bleker SM, Meyer G, Mahé I, Muñoz A, Bertoletti L, Bartels-Rutten A, Beyer-Westendorf J, Porreca E, Boulon C, van Es N, Iosub DI, Couturaud F, Biosca M, Lerede T, Lacroix P, Maraveyas A, Aggarwal A, Girard P, Büller HR, Di Nisio M; UPE investigators. Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study. J Clin Oncol. 2019 Jul 10;37(20):1713-1720. doi: 10.1200/JCO.18.01977. Epub 2019 May 22.

lead_sponsor: G. d'Annunzio University

location_country:
Spain
Italy
Austria
Netherlands
Canada
United States
France
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Malattie Cardiovascolari e Nefrourologiche

location_facility: University hospital Centra La Cavale Blanche

location_facility: Universita degli Studi G. d'Annunzio Chieti e Pescara

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: National Cancer Institute - Antonie van Leeuwenhoek hospital

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova (ASMN)

location_facility: Division of Vascular Medicine, Department of Medicine, Technical University Dresden

location_facility: Hospital Universitario Insular de Gran Canarias

location_facility: Division of Hematology, University of Ottawa

location_facility: Hospital Nuestra Sra del Prado Talavera de la Reina

location_facility: Montpellier et clinique du parc a Castelnau le nez

location_facility: Clinical Division of Haematology, Department of Medicine I


title: Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy

acronym: CAPSCDEIS

summary: The endoscopic capsule is a new tool for exploration of the small intestine. The superiority of this technique on the radiological conventional examinations was shown in Crohn's disease. However no standardization of the lesions exists and no score of severity was proposed. The objective of this exploratory and multicentric study is to develop and validate an endoscopic score of severity especially dedicated to the examination by endoscopic capsule of the small intestine. Hundred twenty patients reached of disease of Crohn corresponding to various groups of severity will be included and will have an examination by video-capsule. The recorded examinations will be the standardized collection of all the lesions observed by independent readers, which will make it possible to evaluate the level of reproducibility of the detection of each lesion. Moreover, each reader will provide his total, qualitative and quantitative evaluations, of the severity of the attack of the small intestine. By using the data of only one reader, a score of severity will be built by simple linear function of the reproducible lesions observed. This score will be validated from the data corresponding to other readers of the same examinations, and those corresponding to another sample. Lastly, the aptitude of this score to detect the changes of the severity of the attack of the small intestine and to define the endoscopic cicatrization will be evaluated from data obtained among patients before and after treatment by infliximab or corticoids

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Amiens
Chu Besancon
Chu Strasbourg
Hopital St Antoine
Hopital Beaujon
Hopital Lariboisiere
CHU NICE
Ulb - Clinique Saint Luc
Chu Saint Etienne
Chu Rouen
CHU CAEN
Chru Lille
Chu Nantes
Chu Tours
Hopital Saint Louis
CHU LIEGE - Sart Tilman
Hopital Georges Pompidou
Hopital Saint Andre
Institut Mutualiste Montsouris (Imm)
Gent University Hospital


title: Study of Once-Daily Versus Twice-Daily Fosamprenavir Plus Ritonavir, Administered With Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects.

summary: This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults. This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort analysis of approximately 200 subjects and 2) if study continuation criteria are met at this interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of 48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg BID and 2) a superior fasting non-HDL lipid profile in subjects receiving fosamprenavir/ritonavir 1400mg/100mg QD.

ReferenceCitation: Ross LL, Robinson MD, Carosi G, et al. Impact of HIV subtype on response and resistance in antiretroviral-naïve adults comparing treatment with once daily versus twice daily Ritonavir boosted Fosamprenavir in combination with Abacavir/Lamivudine. [Drugs Ther Stud]. 2012;2(e1):

ReferenceCitation: Carosi G, Lazzarin A, Stellbrink H, et al. Efficacy and Safety of Fosamprenavir + Ritonavir (FPV/RTV) 700mg/100mg Twice Daily (BID) Versus FPV/RTV 1400mg/100mg Once Daily (QD) with ABC/3TC QD over 24 Weeks. Abstract H-1244, 48th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2008.

ReferenceCitation: Carosi, Lazzarin, Stellbrink, Moyle, Rugina, Staszewski, Givens, Ross, Granier, Ait-Khaled, Leather, Nichols. Study of once-daily versus twice-daily fosamprenavir plus ritonavir administered with abacavir/lamivudine once daily in antiretroviral-naïve HIV-1-infected adult subjects. HIV Clin Trials. 2009 Nov-Dec;10(6):356-67. doi: 10.1310/hct1006-356.

ReferenceCitation: Hughes S, Cuffe RL, Lieftucht A, Garrett Nichols W. Informing the selection of futility stopping thresholds: case study from a late-phase clinical trial. Pharm Stat. 2009 Jan-Mar;8(1):25-37. doi: 10.1002/pst.323.

lead_sponsor: ViiV Healthcare

location_country:
Belgium
Spain
Italy
Russian Federation
United Kingdom
Switzerland
France
Romania
Germany


title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

summary:
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

lead_sponsor: Forest Laboratories

location_country:
Poland
Spain
Italy
Russian Federation
Netherlands
Hungary
France
Belgium
Germany

location_facility: Klinik am See REHA-Zentrum fur Herz und Kreislauf

location_facility: Klinkum Lippe-Detmold Med. Klink II-Kardiologie

location_facility: Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11

location_facility: St Elisabeth Ziekenhuis Afdeling Cardiologie

location_facility: Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1

location_facility: Hospital Universitari San Juan Servicio di Cardiologia

location_facility: Franz-Volhard-Klinik Abteilung fur Elektrophysiologie

location_facility: Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii

location_facility: Department of Emergency Cardiology Russian Cardiology Research Centre

location_facility: Service de Cardiologie Hopital Lariboisiere

location_facility: Centre Hospitalier General Hospital De Girac

location_facility: I Klinika Chorob Serca Instytut Kardiologii AM

location_facility: Cardiology Department St Petersburg Hospital No. 2

location_facility: Cardiology Department St. Petersburg State Pavlov Medical University

location_facility: Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie

location_facility: Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie

location_facility: Markusovszky Hospital, Dept. of Internal Medicine III.

location_facility: Department of Cardiology No. 3 Pokrovskiy Hospital

location_facility: Cardiovascular Disease Unit University of Bari-Ploiclinico

location_facility: Myocardial Infarction Department St Elizabeth Hospital

location_facility: Medizinische Klinik und Poliklinik Innere Medizin C

location_facility: Gornoslaskie Centrum Medyczne I Klinika Kardiologii

location_facility: Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie

location_facility: Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I

location_facility: Service de Cardiologie Hopital Saint Philibert

location_facility: Clinique Generale Saint Jean Service de cardiologie

location_facility: Fundacion Jimenez Diaz Cardiology Service

location_facility: County Hospital, Dept. of Internal Medicine I.

location_facility: Cardiology Department, Moscow Clinical Hospital No. 59

location_facility: S. Paolo Hospital University of Milan Department of Cardiology

location_facility: Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48

location_facility: Cardiology Unit University of Naples "Frederico II"

location_facility: Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny

location_facility: Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51

location_facility: Academisch Ziekenhuis Maastricht Afdeling Cardiologie

location_facility: Oddzial Kardiologii Wojewodzkie Centrum Medyczne

location_facility: Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50

location_facility: Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela

location_facility: Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva

location_facility: Szent Imre Hospital, Dept. of Internal MedicineI.

location_facility: Cardiology Department, State Research Institute

location_facility: Oddzial Kardiologii Wojewodzki Szpital Zespolony

location_facility: Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum

location_facility: Cardiology Division Hospital "Santa Croce e Carle"

location_facility: Osp. Civile di Piacenza-Div. di Cardiologia

location_facility: Kerckhhoff-Klinik Abteilung Klinische Pharmakologie

location_facility: Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii

location_facility: Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute

location_facility: Cardiology Department Alexandrovskiy Hospital

location_facility: Hospital Valle de Hebron Servicio de Cardiologia

location_facility: Hospital Civil De Basurto Cardiology Service

location_facility: Radomski Szpital Specjalistyczny Oddzial Kardiologii

location_facility: Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou

location_facility: Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4

location_facility: Klinika Kardiologii IV Wojskowy Szpital Kliniczny

location_facility: Cardiology Department, St Petersburg Hospital, No. 15

location_facility: Gottsegen Gyorgy National Institute of Cardiology

location_facility: Myocardial Infarction Department St Petersburg Hospital, No. 28

location_facility: Oddizial Kardiologii Szpital Wojewodzki nr 2

location_facility: Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64

location_facility: Medizinische Universitats-und Ploiklinik Innere Medizin 3

location_facility: Hospital Universitario De Getafe Cardiology Service

location_facility: Erzgebirgskrankenhaus Klinik fur Innere Medizin

location_facility: Toldi Ferenc Hospital, Dept. of Internal Medicine II.

location_facility: Oddizial Kardiologii Wojewodzki Szpital Zespolony

location_facility: Cardiologie CHRU St Etienne/Hopital Nord

location_facility: Department of Internal Medicine (DIMI) University of Genova

location_facility: Cardilolgie Hopital Guillaume et Rene Laennec

location_facility: Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie

location_facility: Wojewodzki Szpital Zespolony Oddzial Kardilolgii

location_facility: Divisione di Cardiologia Ospedale Civile

location_facility: Medizinische Klinik und Poliklnik Innere Medizin C

location_facility: Reinhard-Nieter-Krankenhaus Med. Klinik 1

location_facility: Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia

location_facility: Servizio di Cardiologia Azienda Ospedaliera S. Anna

location_facility: County Hospital, Dept. of Internal Medicine

location_facility: Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii

location_facility: Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie

location_facility: Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies

location_facility: Semmelweis University, Dept. of Internal Medicine III.

location_facility: Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie

location_facility: Myocardial Infarction Department St Petersburg Hodpital, No. 29

location_facility: Hospital Clinico Universitario San Carlos Servicio de Cardiologia

location_facility: Service de cardiologie Hopitaux de Brabois/CHRU Nancy

location_facility: Ospedale Civile Umberto I Cardiology Division

location_facility: Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29

location_facility: Department Cardiology Canisius Wilhelmina Hospital

location_facility: Service de Cardiologie A Hopital Cardiologique

location_facility: Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie

location_facility: Instytut Kardiologii CMUJ Klinika Choroby Wiencowej

location_facility: Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia

location_facility: Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan

location_facility: National Institiute of Pulmonology, Dept. of Cardiology

location_facility: Universitate zu Koeln Klinik III fur Innere Medizin

location_facility: Cardiology Department Moscow Sechenov Medical Academy


title: Prospective Multi-country Observational Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Patient-reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Patients

acronym: AQUARiUS

summary: The purpose of this observational study of metastatic castration-resistant prostate cancer (mCRPC) participants is to explore whether or not there are differences between participants treated with abiraterone acetate and enzalutamide on the health-related quality of life (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).

ReferenceCitation: Thiery-Vuillemin A, Poulsen MH, Lagneau E, Ploussard G, Birtle A, Dourthe LM, Beal-Ardisson D, Pintus E, Trepiakas R, Lefresne F, Lukac M, Van Sanden S, Pissart G, Reid A; AQUARiUS Investigators. Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study. Eur Urol. 2020 Mar;77(3):380-387. doi: 10.1016/j.eururo.2019.09.019. Epub 2019 Oct 5.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Denmark
France
United Kingdom


title: Phase II, Open-Label Study Evaluating Efficacy of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older

summary: This study evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth


title: A Phase Ib Study of Ibrutinib Combined With R-DHAP or R-DHAOx in Patients With B-cell Lymphomas

acronym: BIBLOS

summary:
This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients with B-cell malignancies. This dose escalation will be followed by an exploratory expansion phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C).

During Part 1 Dose Escalation, the "3+3" design will be applied. Three doses of ibrutinib (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation Committee. Dose escalation will begin at dose level 1 = 420 mg.

The dose escalation will be performed for two types of associations in five separate groups :

Group A : ibrutinib D1-D21+ R-DHAP
Group B : ibrutinib D1-D21 R-DHAOx
Group Abis : ibrutinib D5-D18+ R-DHAP
Group Bbis : ibrutinib D5-D18 R-DHAOx

This dose escalation will be followed by an exploratory expansion phase in the group Bbis plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C. Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion of each patient.

status: Terminated

location_facility: Universite Catholique de Louvain Saint Luc

location_facility: Centre François Magendie - Hôpital du Haut Lévêque

status_simplified: Unknown


title: An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity

summary: To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

ReferenceCitation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.

ReferenceCitation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Poland
Spain
Italy
United Kingdom
Czech Republic
Hungary
France
Turkey
Germany


title: Evaluation of the Efficacy of MaaT013 as Salvage Therapy in Acute GVHD Patients With Gastrointestinal Involvement, Refractory to Ruxolitinib; a Multi-center Open-label Phase III Trial.

acronym: ARES

summary: MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.

lead_sponsor: MaaT Pharma

location_country: Spain Austria France Belgium Germany

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hospital Universitario Marqués de Valdecilla


acronym: TPEx

intervention_type: Biological

title: Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

ReferenceCitation: Guigay J, Fayette J, Dillies AF, Sire C, Kerger JN, Tennevet I, Machiels JP, Zanetta S, Pointreau Y, Bozec Le Moal L, Henry S, Schilf A, Bourhis J. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Ann Oncol. 2015 Sep;26(9):1941-1947. doi: 10.1093/annonc/mdv268. Epub 2015 Jun 24.

location_facility: Clinique universitaire de Mont Godinne UCL

summary: PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.


title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures

summary: To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.

lead_sponsor: Eisai Limited

location_country:
Denmark
United Kingdom
Italy
Austria
France
Norway
Germany

location_facility: Avd. for nevrologi og klinisk nevrofysiologi

location_facility: Universitatsklinikum Campus Virchow-Klinikum Wedding

location_facility: Azienda Ospedaliero- Universitaria Policlinico di Catania

location_facility: Istituto Nazionale Neurologico Carlo Besta di Milano

location_facility: University Hospital of North Staffordshire Royal Infirmary


title: Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

ReferenceCitation: Forster MD, Dillon MT, Kocsis J, Remenár É, Pajkos G, Rolland F, Greenberg J, Harrington KJ. Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. Eur J Cancer. 2019 Dec;123:36-47. doi: 10.1016/j.ejca.2019.08.017. Epub 2019 Oct 21.

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Poland
Romania
United Kingdom
Hungary
France
Belgium
Germany

location_facility: Centre Hospitalier de Bordeaux - Hôpital Saint André

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum

location_facility: The Shrewsbury and Telford Hospital NHS Trust

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

location_facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes

summary: The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

lead_sponsor: Janssen-Cilag International NV

location_country:
Greece
Russian Federation
France
Germany
Bulgaria


title: First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.

PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.

ReferenceCitation: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Retraction--Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2011 Feb;12(2):116. doi: 10.1016/S1470-2045(11)70011-0.

ReferenceCitation: Desmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Multifactorial approach to predicting resistance to anthracyclines. J Clin Oncol. 2011 Apr 20;29(12):1578-86. doi: 10.1200/JCO.2010.31.2231. Epub 2011 Mar 21.

ReferenceCitation: Bonnefoi H, Piccart M, Bogaerts J, Mauriac L, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Blot E, Zaman K, Cufer T, Lortholary A, Lidbrink E, André S, Litière S, Lago LD, Becette V, Cameron DA, Bergh J, Iggo R; EORTC 10994/BIG 1-00 Study Investigators. TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00): a randomised phase 3 trial. Lancet Oncol. 2011 Jun;12(6):527-39. doi: 10.1016/S1470-2045(11)70094-8. Epub 2011 May 11. Erratum in: Lancet Oncol. 2013 Feb;14(2):e47.

ReferenceCitation: Bonnefoi HR, Bogaerts J, Piccart M, et al.: Phase III trial (EORTC 10994/BIG 00-01) assessing the value of p53 using a functional assay to predict sensitivity to a taxane versus nontaxane primary chemotherapy in breast cancer: final analysis. [Abstract] J Clin Oncol 28 (Suppl 18): A-LBA503, 2010.

ReferenceCitation: Collingridge D. Expression of concern--validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2010 Sep;11(9):813-4. doi: 10.1016/S1470-2045(10)70185-6. Epub 2010 Jul 26.

ReferenceCitation: Bonnefoi H, Zimmer AS, Piccart M, et al.: P53 functional assay in yeast: evaluation in 1856 patients in a large prospective clinical trial: EORTC 10994/BIG 00-01. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1067, 2008.

ReferenceCitation: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2007 Dec;8(12):1071-1078. doi: 10.1016/S1470-2045(07)70345-5. Epub 2007 Nov 19. Retraction in: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Lancet Oncol. 2011 Feb;12(2):116.

ReferenceCitation: Karina M, Bogaerts J, Piccart M, et al.: Preliminary safety data of the EORTC 10994/BIG 00-01 neoadjuvant trial comparing 3 cycles of docetaxel followed by 3 cycles of epirubicin-docetaxel versus 6 cycles of FEC 100 in patients with locally advanced/inflammatory or large operable breast cancer. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3067, S146-7, 2006.

ReferenceCitation: Bonnefoi H, Farmer P, Delorenzi M, et al.: Is there a regimen-specific gene signature predicting for pathological complete response after neoadjuvant chemotherapy in hormone-negative breast cancer patients? A microarray substudy of 101 patients included in EORTC 10994/BIG 00-01 trial. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1040, 2005.

ReferenceCitation: Farmer P, Iggo R, Becette V, et al.: High quality gene expression microarray data from a multicentre prospective trial: results of the first microarray analysis in the EORTC 10994/ BIG 00-01 study. [Abstract] Eur J Cancer 2 (Suppl 3): A-155, 99, 2004.

ReferenceCitation: Chatzipli A, Bonnefoi H, MacGrogan G, Sentis J, Cameron D, Poncet C; EORTC 10994/BIG 1-00 Consortium, Iggo R. Patterns of genomic change in residual disease after neoadjuvant chemotherapy for estrogen receptor-positive and HER2-negative breast cancer. Br J Cancer. 2021 Nov;125(10):1356-1364. doi: 10.1038/s41416-021-01526-3. Epub 2021 Sep 3.

ReferenceCitation: Bonnefoi H, Litière S, Piccart M, MacGrogan G, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Moldovan C, Bodmer A, Zaman K, Cufer T, Campone M, Luporsi E, Malmström P, Werutsky G, Bogaerts J, Bergh J, Cameron DA; EORTC 10994/BIG 1-00 Study investigators. Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial. Ann Oncol. 2014 Jun;25(6):1128-36. doi: 10.1093/annonc/mdu118. Epub 2014 Mar 11.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Poland
Portugal
Slovenia
United Kingdom
Switzerland
Sweden
France
Belgium
Netherlands

location_facility: Swiss Institute for Applied Cancer Research

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Karolinska University Hospital - Huddinge

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Sahlgrenska University Hospital - Molndal at Gothenburg University


title: Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry

acronym: BENCHMARK

summary:
Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.

The registry will consist of the following phases:

Retrospective phase (purpose: capture the status quo of each site prior to any Quality of Care improvement measures): The TAVI of patients being eligible for retrospective documentation must have been performed prior to the site's enrollment into the BENCHMARK prospective phase (follow-up: 30 days, 12 months).
Education phase: Each center will undergo an online BENCHMARK education. The contents of the education will be: Reflection on treatment pathways with the TAVI team, education on 8 defined Quality of Care improvement measures, followed by a center self-assessment (to self-assess the current alignment of hospital performance with the BENCHMARK Quality od Care measures).
Implementation phase: After having self-assessed the current alignment of hospital performance with the following BENCHMARK Quality of care measures, each center will start to introduce the tailored Quality of Care improvement measures to their hospital routine within a time frame of 2 months.
Prospective phase (purpose: to document the effects of defined quality of care improvement measure and to make sure patient safety is as least as good as in the retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)

ReferenceCitation: McCalmont G, Durand E, Lauck S, Muir DF, Spence MS, Vasa-Nicotera M, Wood D, Saia F, Chatel N, Lüske CM, Kurucova J, Bramlage P, Frank D. Setting a benchmark for resource utilization and quality of care in patients undergoing transcatheter aortic valve implantation in Europe-Rationale and design of the international BENCHMARK registry. Clin Cardiol. 2021 Oct;44(10):1344-1353. doi: 10.1002/clc.23711. Epub 2021 Sep 9.

ipd_sharing_description: no individual participant data (IPD) will be shared

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country: Spain Italy Austria France Romania Germany Czechia

location_facility: Hospital Regional Universitario de Málaga

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: IMM (Institut Mutualiste Montsouris) Paris

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Institutul de Urgenta pentru Boli Cardiolvasculaire

location_facility: L'Ospedale S.Giuseppe Moscati di Avellino


title: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.

acronym: FIRST

summary:
The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms.

All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study.

The patient's inclusion and follow up in the study will occur as part of their usual standard of care.

lead_sponsor: Balt Extrusion

location_country: Croatia Spain Italy Austria Netherlands France Israel Belgium Germany

location_facility: Hospices Civils de Lyon - Hôpital Neurologique

location_facility: Hospital Clinico Universitario de Valladolid


title: A Single-Arm, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of Necitumumab in Combination With Abemaciclib in Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

summary: This is medical research evaluating the safety and efficacy of two new medicines (necitumumab and abemaciclib), administered in combination in participants affected by a defined type of advanced lung cancer (stage IV non-small-cell lung cancer).

lead_sponsor: Eli Lilly and Company

location_country: France Spain Belgium

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.

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: BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III

acronym: BIOFLOW-III

summary: This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

status: Unknown status

ReferenceCitation: Toelg R, Slagboom T, Waltenberger J, Lefèvre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.

ReferenceCitation: Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Fröbert O, Seige M, Friedrich G, Erglis A, Winkens M, Hegeler-Molkewehrum C, Neef M, Hoffmann S; BIOFLOW-III Investigators. Five-Year Results of the Bioflow-III Registry: Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent. Cardiovasc Revasc Med. 2020 Jan;21(1):63-69. doi: 10.1016/j.carrev.2019.03.004. Epub 2019 Mar 15.

ReferenceCitation: Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Fröbert O, Seige M, Erglis A, Dewilde W, Winkens M, Hegeler-Molkewehrum C, Klein N, Hoffmann S; BIOFLOW-III Investigators. Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. EuroIntervention. 2016 Feb;11(10):1106-10. doi: 10.4244/EIJY15M03_08.

lead_sponsor: Biotronik AG

location_country:
Denmark
Portugal
Spain
Italy
Austria
Latvia
Netherlands
United Kingdom
Switzerland
Sweden
France
Chile
Germany

location_facility: Riga Eastern Clinical University Hospital

location_facility: Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I

location_facility: Klinikum Landshut-Achdorf Medizinische Klinik I

location_facility: Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata

location_facility: Uniklinik Heidelberg, Medizinische Uniklinik

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Universitetssjukhuset Oerebro, Kardiologiska Kliniken

location_facility: Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland

location_facility: HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin


primary_purpose: Prevention

title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

lead_sponsor: GlaxoSmithKline

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country: Germany Canada France

summary: This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.


title: Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma

summary:
This pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. The different research focusses are:

Identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (Focus 1)
Identification of molecular tumor characteristics in long-term survivors (Focus 2)
Assessment of therapy-related parameters, including neuro-toxicity (Focus 3)
Immunological studies (Focus 4)

time_perspective: Cross-Sectional

location_country:
Greece
Austria
Italy
Netherlands
Switzerland
United States
France
Belgium
Germany

location_facility: Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni

location_facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar

location_facility: Universitaetsklinikum Wien - AKH uniklinieken

location_facility: Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: Dana-Farber Cancer Institute & Harvard Medical School

location_facility: Hopitaux de Paris - La Pitie Salpetriere

location_facility: CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne


title: A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Hong Kong
Spain
Italy
Russian Federation
Korea, Republic of
United States
France
Turkey

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Adana Acıbadem Hospital Oncology Department

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Ege University Medical Faculty; Chest Diseases

location_facility: Queen Elizabeth Hospital Department of Clinical Oncology

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

summary: The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.


acronym: FAIRPARKII

title: Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone"

lead_sponsor: University Hospital, Lille

type: Other Grant/Funding Number

ReferenceCitation: Mahoney-Sánchez L, Bouchaoui H, Ayton S, Devos D, Duce JA, Devedjian JC. Ferroptosis and its potential role in the physiopathology of Parkinson's Disease. Prog Neurobiol. 2021 Jan;196:101890. doi: 10.1016/j.pneurobio.2020.101890. Epub 2020 Jul 26. Review.

ReferenceCitation: Moreau C, Duce JA, Rascol O, Devedjian JC, Berg D, Dexter D, Cabantchik ZI, Bush AI, Devos D; FAIRPARK-II study group. Iron as a therapeutic target for Parkinson's disease. Mov Disord. 2018 Apr;33(4):568-574. doi: 10.1002/mds.27275. Epub 2018 Jan 30. Review.

location_country:
Portugal
Spain
United Kingdom
Austria
Netherlands
France
Germany
Czechia

location_facility: Centro Hospitalar e universitario de Coimbra

location_facility: CHU de Strasbourg, Hôpital de Hautepierre

location_facility: Klinik und Poliklinik für Neurologie der Universitätsmedizin Rostock

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University Hospital, Saarland University

summary: This study evaluates the effect of iron chelation as a therapeutic strategy to slow the progression of Parkinson's disease. Half of participants will receive the deferiprone to 15 mg / kg twice daily morning and evening (30mg / kg per day), while the other half will receive a placebo. The treatment lasts nine months.


acronym: SEQTOR

title: Randomized Open Label Study to Compare the Efficacy and Safety of Everolimus Followed by Chemotherapy With Streptozotocin- Fluorouracilo (STZ-5FU) Upon Progression or the Reverse Sequence, in Advanced Progressive Pancreatic NETs (pNETs)

lead_sponsor: Grupo Espanol de Tumores Neuroendocrinos

ipd_sharing_description: As per GETNE guidelines and local laws

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Germany

location_facility: Instituto Catalán de Oncología de Hospitalet

location_facility: Medizinische Klinik und Poliklinik , Universitätsklinikum Hamburg-Eppendorf

location_facility: Marburg Universitätsklinikum Giessen und Marburg GmbH

location_facility: Brest Hopital Augustin Morvan, Institut de Cancero-Hemato

location_facility: Interdisciplinary Center of Neuroendocrine Tumors of the GastroEnteroPancreatic System (GEPNET-KUM) at the University of Munich

location_facility: University Hospital of Bordeaux Hôpital Saint-André

location_facility: UTTIOM Unité Transversale de Thérapeutiques Innovantes en Oncologie Médicale CHU Angers

location_facility: Medizin II am Klinik und Poliklinik rechts der Isar

location_facility: Magdeburg Universitätsklinikum Magdeburg A. ö. R

location_facility: Istituto Nazionale Tumori (Fondazione G Pascale)

location_facility: UKM Facharzt für Innere Medizin Gastroenterologie, Onkologische Gastroenterologie (DGVS)

location_facility: Rigshospitalet NET CoE, University of Copenhagen

location_facility: Aarhus Aarhus University Hospital NET Centre (AUH-NET)

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre

location_facility: Clichy Neuroendocrine Tumor (NET) Center Hopital Beaujon

location_facility: Hospital Universitario Germans Trias i Pujol

summary: The purpose of this study is to compare STZ vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of streptozotocin (STZ) based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.


title: A Multi-center, Phase IB/II, Open Label, Single Arm Study of Inotuzumab Ozogamicin Plus Rituximab (R-CMC544) Alternating With Gemcitabine-oxaliplatin Plus Rituximab(R-GEMOX)in Patients Aged From 18 to 80 Years With CD20 and CD22 Positive Diffuse Large B-cell Lymphoma (DLBCL) in Relapse After/Refractory to 1ST or 2ND Line Treatment, Who Are no Candidates for Autologous Transplant.

summary: The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility:
CHU Mont-Godinne
CHU Brabois
CHU Pontchaillou
CHU de Dijon
University Hospital Gent
AZ Sint Jan
CHRU de Lille
Centre Henri Becquerel
Hôpital Henri Mondor
CHU Lyon - Sud
CHU Hôtel Dieu


title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the TAXUS® Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

acronym: TE-Prove

summary: The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

ReferenceCitation: Tamburino C, Capodanno D, Erglis A, Menown IB, Horváth IG, Moreno R, Gilbert TJ, Crowley JJ, Calabria P, Allocco DJ, Dawkins KD. One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE). EuroIntervention. 2015 Mar;10(11):1261-6. doi: 10.4244/EIJY15M01_01.

ipd_sharing_description: Primary endpoint data presented at TCT 2014.

lead_sponsor: Boston Scientific Corporation

location_country:
Poland
Spain
Ireland
Italy
Latvia
United Kingdom
Hungary
France
Belgium
Germany

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

location_facility: Centre Hospitalier Privé Saint Martin gds

location_facility: Norfolk and Norwich University Hospital NHS Trust

location_facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR


title: A Prospective, Multi-centre, Randomized, Open-label, Parallel, Comparative Study to Evaluate Effects of AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

summary: A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.

lead_sponsor: ConvaTec Inc.

location_country:
Denmark
Poland
United Kingdom
France
Germany

location_facility: Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)

location_facility: Chalfont and Gerrards Cross Hospital (#14)

location_facility: Tissue Viability Service NHS Harrow PCT (#26)

location_facility: Fareham College Specialist Leg Care Centre (#13)

location_facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)

location_facility: Distric Nurses, The Wilson Practice, Alton Health Centre (#9)

location_facility: Mayday University Hospital Wound Clinic (#10)

location_facility: Tissue Viability Service, The Willows, Centre for Health Care (#11)


title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy

summary: The purpose of this study is to evaluate the clinical activity and safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-induction therapy in adult patients with WT1-positive AML presenting a suboptimal clinical response to induction chemotherapy. The study will also assess whether this treatment induces a specific immune response to the malignancy.

location_country:
Germany
United States
France


title: Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy

acronym: RESCUE

summary: Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

lead_sponsor: Guerbet

location_country: France Italy Spain Belgium

location_facility: Azienda Ospedaliera Universitaria di Ferrara


title: An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate

summary: To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Finland
France
Sweden


title: A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast 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: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.

ReferenceCitation: Coudert B, Focan C, Genet D, Giacchetti S, Cvickovic F, Zambelli A, Fillet G, Chollet P, Amoroso D, Van Der Auwera J, Lentz MA, Marreaud S, Baron B, Gorlia T, Biville F, Lévi F. A randomized multicenter study of optimal circadian time of vinorelbine combined with chronomodulated 5-fluorouracil in pretreated metastatic breast cancer patients: EORTC trial 05971. Chronobiol Int. 2008 Sep;25(5):680-96. doi: 10.1080/07420520802384036.

location_country: France Italy Greece Belgium

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Istituto per la Ricerca e Cura del Cancro

location_facility: Azienda Ospedale S. Luigi - Universita Di Turin

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman


title: A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination With Anti-Cancer Agents in Adult Participants With Metastatic Pancreatic Adenocarcinoma

acronym: SIRACUSA

summary: The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas. Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase. The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body. Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-flurouracil (5-FU) and leucovorin (LV).

lead_sponsor: Ipsen

location_country: Portugal Spain Italy Australia Hungary France Germany

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E

location_facility: Universitätsklinikum Ulm -Zentrum Für Innere Medizin

location_facility: Peninsula and Southeast Oncology - Frankston Private Hospital

location_facility: Hospital Universitari de Lleida Arnaud de Villanova

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Caritasklinikum Saarbruecken St Theresia

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela -Chus

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Institut BERGONIE Centre de Lutte Contre le Cancer


title: Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)

acronym: InEurHeart

summary: This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tailored strategy which identifies targets based on pre-procedural CT-scan imaging. The primary endpoint will be procedure duration and secondary endpoints will include safety and efficacy criteria as well as medico-economic evaluation.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Bordeaux

location_country: Austria Germany France Switzerland

location_facility:
APHP Salpétrière
Deutsches Herzzentrum München
Luzerner Kantonsspital
CHU de Clermont-Ferrand
Public Hospital Elisabethinen Linz
CHU de Toulouse
Rhön-Klinikum AG
Medical University of Graz
CHU de Bordeaux
Vaudois University Hospital, Lausanne
CHU de Limoges
Inuversitäres Herzzentrum Leipzig
Inselspital, Universitätsspital Bern
Evangelisches Krankenhaus Düsseldorf
Asklepios Klinik St. Georg Hamburg


title: Safe Anastomosis Feasibility Study: a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac+ Colorectal Anastomosis Protection Device

summary: A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer

lead_sponsor: SafeHeal Inc

location_facility: Centre Hospitalier Universitaire St Pierre


acronym: CYCLONE 1

title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
United States
Spain
France

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Utah - Huntsman Cancer Institute

summary: The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.


title: POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study

acronym: POLAR ICE

summary: This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

location_country:
Croatia
United Kingdom
Italy
Netherlands
France
Belgium
Germany

location_facility: CHU De Brest - Hopital de la Cavale Blanche

location_facility: Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina


title: Safety and Effectiveness of SOFIA™/SOFIA™ PLUS When Used for Direct Aspiration as a First Line Treatment Technique in Patients Suffering an Acute Ischemic Stroke in the Anterior Circulation

acronym: SESAME

summary:
Sesame is a European, multi-center, single arm, prospective, observational registry.

Sesame aims to demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment. 250 patients will be enrolled. All patients will be followed for 90 days or until death.

lead_sponsor: Dr. Markus Alfred Möhlenbruch

location_country: Italy Austria Netherlands France Germany

location_facility: Groupe Hospitalier Universitaire Pitié Salpêtrière

location_facility: Le Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) as Compared With Methylphenidate in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Multicentre Randomized Clinical Study

acronym: Newrofeed

summary: The main objective of the study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder.

ReferenceCitation: Purper-Ouakil D, Blasco-Fontecilla H, Ros T, Acquaviva E, Banaschewski T, Baumeister S, Bousquet E, Bussalb A, Delhaye M, Delorme R, Drechsler R, Goujon A, Häge A, Kaiser A, Mayaud L, Mechler K, Menache C, Revol O, Tagwerker F, Walitza S, Werling AM, Bioulac S, Brandeis D. Personalized at-home neurofeedback compared to long-acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial. J Child Psychol Psychiatry. 2022 Feb;63(2):187-198. doi: 10.1111/jcpp.13462. Epub 2021 Jun 24.

ReferenceCitation: Bioulac S, Purper-Ouakil D, Ros T, Blasco-Fontecilla H, Prats M, Mayaud L, Brandeis D. Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD. BMC Psychiatry. 2019 Aug 1;19(1):237. doi: 10.1186/s12888-019-2218-0.

lead_sponsor: Mensia Technologies SA

location_country: Spain Switzerland France Belgium Germany

location_facility: PSY Pluriel Centre europeen de psychologie medicale

location_facility: CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent

location_facility: Hôpital Erasme - Cliniques universitaires de Bruxelles

location_facility: Puerta de Hierro Hospital - Department of Psychiatry

location_facility: Psychiatric Hospital, University of Zürich

location_facility: Medical faculty of Mannheim/Heidelberg university

location_facility: Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant


title: A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)

summary: This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME

lead_sponsor: Boehringer Ingelheim

location_country:
Portugal
Spain
Greece
United Kingdom
Hungary
France
Belgium
Germany

location_facility: BAZ County Hospital, Ophtalmology Department, Miskolc

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light and Image

location_facility: University General Hospital of Heraklion

location_facility: Augenarzt Dr. Dunker und Kollegen, Troisdorf

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Attikon, Panepistimiako Geniko Nosokomeio