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

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

status: Unknown status

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

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

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

family: Hermine

full_name: Olivier Hermine

given: Olivier

family: Hoster

full_name: Eva Hoster

given: Eva

family: Walewski

full_name: Jan Walewski

given: Jan

family: Bosly

full_name: André Bosly

given: André

family: Stilgenbauer

full_name: Stephan Stilgenbauer

given: Stephan

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Szymczyk

full_name: Michal Szymczyk

given: Michal

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: Kneba

full_name: Michael Kneba

given: Michael

family: Hallek

full_name: Michael Hallek

family: Salles

full_name: Gilles Salles

given: Gilles

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Birkmann

full_name: Josef Birkmann

given: Josef

family: Forstpointner

full_name: Roswitha Forstpointner

given: Roswitha

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Hänel

full_name: Mathias Hänel

given: Mathias

family: Casasnovas

full_name: René Olivier Casasnovas

given: René Olivier

family: Finke

full_name: Jürgen Finke

given: Jürgen

family: Peter

full_name: Norma Peter

given: Norma

full_name: Kamal Bouabdallah

given: Kamal

family: Sebban

full_name: Catherine Sebban

family: Fischer

full_name: Thomas Fischer

given: Thomas

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

name: Department of Biological Hematology and Immunology, Assistance Publique Hôpitaux de Paris (AP-HP), Groupe Hospitalier Mondor, Créteil, France;

name: Institut Mondor de Recherche Biomédicale–INSERM U955, Equipe 9, Henri Mondor Hospital, Créteil, France;

name: Departments of Pathology, Hematopathology Section and Lymph Node Registry, University Hospital Schleswig-Holstein, Kiel, Germany;

name: Department of Pathology, Hospices Civils de Lyon, Lyon-1 University, Pierre Benite, France;

name: INSERM U918, Institute for Research and Innovation in Biomedicine, Centre Henri Becquerel, Rouen, France;

name: Department of Pathology, Hôpital Saint-Louis, AP-HP, Paris, France;

name: Hospices Civils de Lyon, Lyon-1 University, Centre National de la Recherche Scientifique (CNRS), Unite Mixte de Recherche (UMR) 5239, Pierre Benite, France;

name: Centre Hospitalo-Universitaire Brabois, Nancy, France;

name: Lymphoid Malignancies Unit, GH Mondor, AP-HP, Creteil, France;

name: Institut de Cancérologie Gustave Roussy, Villejuif, France;

name: Department of Clinical Hematology, Hôpital Saint-Louis, AP-HP, Paris, France;

name: Department of Internal Medicine III, University Hospital Munich, Munich, Germany;

name: Biological Hematology, Necker Hospital, Paris Descartes, AP-HP, INSERM 1151, Institut Necker Enfants Malades, Paris, France;

name: Second Medical Department, University Hospital Schleswig-Holstein, Kiel, Germany;

name: Department of Clinical Hematology, University Paris Descartes, CNRS, UMR 8147, Necker Hospital, Paris, France; and

name: Department of Medical Informatics, Biometry, and Epidemiology, University of Munich, Munich, Germany

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

name: Eva Hoster, Roswitha Forstpointner, Wolfgang Hiddemann, Martin H. Dreyling, and Michael Unterhalt, University Hospital Munich; Eva Hoster, University of Munich, Munich; Wolfram Klapper, University of Kiel; Christiane Pott, University Hospital Schleswig-Holstein, Kiel; Michael Hallek, Universität Köln, Köln; Stephan Stilgenbauer, University of Ulm, Ulm, Germany; Olivier Hermine, University Paris Descartes and Université Sorbonne Paris Cité; Catherine Thieblemont, Hôpital Saint Louis, Paris; Vincent Ribrag...

publisher: American Society of Clinical Oncology (ASCO)

title: Confirmation of the Mantle-Cell Lymphoma International Prognostic Index in Randomized Trials of the European Mantle-Cell Lymphoma Network

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

name: Second Medical Department, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany;

name: Department of Internal Medicine III, University of Munich, Grosshadern, Germany;

name: Assistance Publique-Hopitaux de Paris, Hôpital Henri-Mondor, Immunology Department, Inserm U955, Equipe 9, Université Paris XII, Créteil, France, for the Groupe d'Etudes de Lymphomes de L'Adulte (GELA);

name: Laboratoire d'Hématologie, Hôpital Necker-Enfants-Malades, Paris, France, for the GELA;

name: Institute of Human Genetics, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany;

name: Service d'Hématologie Biologique, Centre Hospitalier Lyon Sud, Pierre-Bénite, France;

name: Department of Hematology, Rigshospitalet, Copenhagen, Denmark;

name: Department of Immunology, Erasmus MC, Rotterdam, The Netherlands;

name: Institute of Hematopathology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany;

name: Department of Pathology, Centre Hospitalier Lyon-Sud, Lyon, France;

name: Laboratoire de Récherche Translationelle, Institut Gustave Roussy, Villejuif, France;

name: Department of Hematology, University Hospital St Jan, Brugge, Belgium;

name: First Department of Medicine, Charles University, Prague, Czech Republic;

name: Institute of Oncology, Maria Sklodowska-Curie Memorial Cancer Center, Warszawa, Poland;

name: Department of Medicine V, University of Heidelberg, Heidelberg, Germany;

name: Department of Hematology, University Medical Center, University of Groningen, Groningen, The Netherlands; and

name: Department of Clinical Hematology, University Paris Descartes, Centre National de la Recherche Scientifique Unite Mixte de Recherche 8147, Necker Hospital Paris, France, for the GELA

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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

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


title: Open Label, Pilot Phase II Study of Glivec in Children and Adolescents With Life Threatening Diseases Known to Be Associated With One or More Glivec-Sensitive Tyrosine Kinases

summary: The purpose of this study is to determine whether Glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by Glivec.

status: Terminated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
United Kingdom
France
Netherlands

location_facility:
Birmingham Children's Hospital
Institut Gustave-Roussy
Emma Kinderziekenhuis AMC

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


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

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

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Geneva

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Division of Gastroenterology, University Hospital


title: 12-Week, Multinational, Multicenter, Controlled, Open, 1:1 Randomized, Parallel Clinical Trial Comparing the Safety of HMR1964 and Insulin Aspart Used in Continuous Subcutaneous Insulin Infusion (CSII) in Subjects With Type 1 Diabetes Mellitus

summary: The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Sanofi

location_country: Germany France Netherlands

location_facility:
Sanofi-aventis Administrative Office
Hospital de Rangueil

lead_sponsor_type: industriel

status_simplified: Completed


status: Recruiting

study_start_date_type: Actual

lead_sponsor: Astellas Pharma Global Development, Inc.

enrollment_type: Anticipated

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Japan
Singapore
Hungary
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Ironwood Cancer & Research Centers - Chandler

location_facility: University of Colorado Hospital / University of Colorado

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Louisiana State University/ East Jefferson General Hospital

location_facility: New York University (NYU) Cancer Institute

location_facility: Georgia Cancer Specialists / Northside Hospital Cancer Institute

location_facility: University of California Los Angeles Medical Center

location_facility: Saint Francis Hospital / Bon Secours - South Carolina

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Hillman Cancer Center / University of Pittsburgh Medical Center

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: University of California Irvine - Newport

location_facility: University of Texas Southwestern Medical Center

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

type: Other Identifier

type: Registry Identifier

source: euctr

title: An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

summary: This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

status_simplified: Ongoing


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

acronym: IRIS 2

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

lead_sponsor: Pixium Vision SA

location_country:
Austria
France
Spain
Germany
United Kingdom

location_facility: Dept. of Ophthalmology, University of Bonn

location_facility: Universitäts KlinikumKlinik für Augenheilkunde Freiburg

location_facility: Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf

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

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

location_facility: Clinique Ophtalmologique du CHU de Nantes

intervention_type: Device


title: An Open-Label Proof of Concept Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome

summary: The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or thrombocytopenia.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
Brazil
France
Japan
United States
United Kingdom

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

intervention_type: Biological


ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Saudi Arabia
Netherlands
France
Israel
Belgium
Spain
Germany

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Washington University School of Medicine

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

location_facility: University of Texas, MD Anderson Cancer Center

ipd_sharing: Yes

title: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

summary: The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.


title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy

summary: The purpose of the study is to evaluate the safety and efficacy of davunetide for the treatment of Progressive Supranuclear Palsy.

ReferenceType: derived

ReferenceCitation: Höglinger GU, Schöpe J, Stamelou M, Kassubek J, Del Ser T, Boxer AL, Wagenpfeil S, Huppertz HJ; AL-108-231 Investigators; Tauros MRI Investigators; Movement Disorder Society-Endorsed PSP Study Group. Longitudinal magnetic resonance imaging in progressive supranuclear palsy: A new combined score for clinical trials. Mov Disord. 2017 Jun;32(6):842-852. doi: 10.1002/mds.26973. Epub 2017 Apr 24.

name: Department of Neurology; Technische Universität München; Munich Germany

name: German Center for Neurodegenerative Diseases; Munich Germany

name: Department of Neurology; University Hospital Gießen and Marburg; Marburg Germany

family: Höglinger

full_name: Günter U. Höglinger

given: Günter U.

sequence: first

name: Institute for Medical Biometry; Epidemiology and Medical Informatics, Saarland University; Campus Homburg Germany

family: Schöpe

full_name: Jakob Schöpe

given: Jakob

sequence: additional

name: Second Department of Neurology; Attikon University Hospital, University of Athens; Athens Greece

family: Stamelou

full_name: Maria Stamelou

given: Maria

name: Department of Neurology; University of Ulm; Ulm Germany

family: Kassubek

full_name: Jan Kassubek

given: Jan

name: Medical Department; Noscira SA; Madrid Spain

family: del Ser

full_name: Teodoro del Ser

given: Teodoro

name: Memory and Aging Center; Department of Neurology, University of California; San Francisco California USA

family: Boxer

full_name: Adam L. Boxer

given: Adam L.

family: Wagenpfeil

full_name: Stefan Wagenpfeil

given: Stefan

name: Swiss Epilepsy Centre; Klinik Lengg; Zurich Switzerland

family: Huppertz

full_name: Hans-Jürgen Huppertz

given: Hans-Jürgen

name: the Movement Disorder Society-Endorsed PSP Study Group

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Movement Disorders

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Boxer AL, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Golbe LI, Williams DR, Corvol JC, Ludolph A, Burn D, Lorenzl S, Litvan I, Roberson ED, Höglinger GU, Koestler M, Jack CR Jr, Van Deerlin V, Randolph C, Lobach IV, Heuer HW, Gozes I, Parker L, Whitaker S, Hirman J, Stewart AJ, Gold M, Morimoto BH; AL-108-231 Investigators. Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial. Lancet Neurol. 2014 Jul;13(7):676-85. doi: 10.1016/S1474-4422(14)70088-2. Epub 2014 May 27.

full_name: Adam L Boxer

given: Adam L

family: Lang

full_name: Anthony E Lang

given: Anthony E

family: Grossman

full_name: Murray Grossman

given: Murray

family: Knopman

full_name: David S Knopman

given: David S

family: Miller

full_name: Bruce L Miller

given: Bruce L

family: Schneider

full_name: Lon S Schneider

given: Lon S

family: Doody

full_name: Rachelle S Doody

given: Rachelle S

family: Lees

full_name: Andrew Lees

given: Andrew

family: Golbe

full_name: Lawrence I Golbe

given: Lawrence I

location_country:
United States
Germany
France
Australia
Canada
United Kingdom

location_facility: University of Louisville Division of Movement Disorders

location_facility: Toronto Western Hospital University Health Network

location_facility: Universität Rostock Zentrum für Nervenheilkunde und Poliklinik

location_facility: University Hospitals Case Medical CenterNI Movement Disorders Center

location_facility: Neurologisch Klinik der Ruhr-Universität im St. Josef-Hospital

location_facility: University of Minnesota Department of Neuology

location_facility: Colorado Neurological Institute - Rocky Mountain Movement Disorders Ctr, PC

location_facility: University of Kansas Medical Center Parkinson Disease & Movement Disorders Center

location_facility: Universitäts- und Rehabilitationskliniken Ulm

location_facility: The Frances J. Zesiewicz Foundation for Parkinson's Disease at USF

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: Universitätsklinikum Carl Carus an der Technischen Universität

location_facility: Muhammed Ali Parkinson Center and Movement Disorders Clinic

location_facility: Parkinson's Disease & Movement Disorders Clinic

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Clinical Ageing Research Unit (CARU) Newcastle University

location_facility: UMDNJ - Robert Wood Johnson Medical Center

location_facility: Univeristy of North Carolina Department of Neurology

location_facility: University of Utah Center for Alzheimer's Care, Imaging &Research

location_facility: London Sciences Health Center University Hospital

location_facility: CHUM-Notre Dame Hospital Unité de Troubles du Mouvement


title: A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy

summary: The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in causing and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France
Japan


title: Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study

acronym: POSACOVID

summary: COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.

study_type: Observational

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Medical University of Graz

location_country: Italy Austria France

location_facility:
San Martino Polyclinic Hospital IRCCS
Medical University of Graz
University of Rennes


title: A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

summary: The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.

primary_purpose: Other

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underline the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

lead_sponsor: Ipsen

location_country:
United Kingdom
Australia
France

location_facility:
Hôtel Dieu de Nantes
Royal Free Hospital London
Ramsay Hollywood Private Hospital

intervention_type: Other


title: An External Control, Observational, Retrospective Study Assessing the Effect of Pralsetinib Compared With Best Available Therapy for Patients With RET-Fusion Positive Advanced Non-Small Cell Lung Cancer

summary: This is an external control, observational, retrospective study designed to compare clinical outcomes for pralsetinib compared with best available therapy for patients with RET-fusion positive advanced NSCLC.

status: Enrolling by invitation

lead_sponsor: Blueprint Medicines Corporation

location_country:
United States
France
Switzerland

location_facility: University Hospital Center of Toulouse - Larrey Hospital


ipd_sharing_description: There is no plan to share data

lead_sponsor: Abeona Therapeutics, Inc

location_country:
Germany
United States
France

time_perspective: Prospective

location_facility:
Nationwide Children's Hospital
University Hospital Hamburg-Eppendorf
Armand-Trousseau Hospital

title: A Long-term Follow-up Study of Patients With MPS IIIB From Gene Therapy Clinical Trials Involving the Administration of ABO-101 (rAAV9.CMV.hNAGLU)

summary: This is a multicenter, non-interventional, long-term follow-up (LTFU) study in participants who have been treated with ABO-101 in a prior trial. Eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial (up to 5 years post-treatment).


title: Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.

summary: Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.

lead_sponsor: Mayo Clinic

location_country:
United States
Hungary
France

location_facility:
University of Debrecen
Mayo Clinic in Florida
Université de Lorraine, CHU de Brabois


title: An Open-Label Adaptive-Design Study of Intracisternal Adenoassociated Viral Vector Serotype rh.10 Carrying the Human β-Galactosidase cDNA for Treatment of GM1 Gangliosidosis

summary: LYS-GM101 is a gene therapy for GM1 gangliosidosis intended to deliver a functional copy of the GLB1 gene to the central nervous system. This study will assess, in a 2-stage adaptive-design, the safety and efficacy of treatment in subjects with infantile GM1 gangliosidosis.

lead_sponsor: LYSOGENE

location_country:
United States
United Kingdom
France

location_facility: Hôpital Armand-Trousseau, Centre de Référence des Maladies Lysosomales (CRML), Service de Neuropédiatrie

location_facility: Manchester University NHS Foundation Trust

location_facility: Children's Hospital of Orange County (CHOC)

intervention_type: Genetic


title: Decision Support System to Evaluate VENTilation in ARDS (DeVENT)

acronym: DeVENT

summary:
Patients with Acute Respiratory Distress Syndrome (ARDS) residing in the intensive care unit (ICU) often require support for their breathing from a mechanical ventilator to provide adequate gas exchange, and although it is life-saving in this setting, it is also known to contribute to the morbidity and mortality in the condition.

Mechanical ventilation delivers a volume and pressure of gas for each breath and can vary oxygen levels. Selecting the correct oxygen, pressure and volume levels is important, as incorrect levels can harm the patient, and result in an increased time connected to the ventilator.

Recently, a system has been developed (the Beacon Caresystem) which advises the healthcare practitioner by the bedside as to how to best set the ventilator. This system is based on mathematics which describes the patients disease and may therefore provide ventilator settings which better suit the individual.

The purpose of this study is to compare mechanical ventilation in ARDS patients following advice from the Beacon Caresystem to that of standard care to investigate whether the use of the system results in improved ventilation in all severities and phases of ARDS and thus reducing morbidity in ARDS. The investigators plan to recruit 110 patients (50 in the UK and 30 in each of the other 2 sites). The study also aims to examine the biological and physiological factors that determine the worsening of ARDS and the processes involved in recovery from ARDS with the aim to develop new therapies to help detect the condition and improve recovery.

The investigators will utilise all raw data will be collected from the Beacon Caresystem to physiologically characterise the progression and resolution phases of ARDS.

Additionally blood and Urine samples will be taken from healthy volunteers (100 in total) as a control comparison group for the biological analyses carried out in the DeVENT study.

primary_purpose: Diagnostic

lead_sponsor: Imperial College London

location_country:
Austria
United Kingdom
France

location_facility: Imperial College London, Royal Brompton Hospital campus


title: Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy

acronym: EarlyHABIT-ILE

summary: Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

ReferenceCitation: Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.

family: Araneda

full_name: R. Araneda

given: R.

family: Sizonenko

full_name: S. V. Sizonenko

given: S. V.

family: Newman

full_name: C. J. Newman

given: C. J.

family: Dinomais

full_name: M. Dinomais

given: M.

family: Le Gal

full_name: G. Le Gal

given: G.

family: Nowak

full_name: E. Nowak

given: E.

family: Guzzetta

full_name: A. Guzzetta

given: A.

family: Riquelme

full_name: I. Riquelme

given: I.

family: Brochard

full_name: S. Brochard

given: S.

family: Bleyenheuft

full_name: Y. Bleyenheuft

given: Y.

currency_apc_doaj: GBP

journal_name: BMC Neurology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of Geneva - Archive ouverte UNIGE

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Institute of Neuroscience, Université catholique de Louvain


lead_sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

location_country: Belgium France Spain

location_facility:
Pitié Salpêtrière Hospital
Hospital Ramón y Cajal
Université Libre de Bruxelles

title: Prospective, Randomized, Open, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of the MON4STRAT Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection MON4STRAT Study

summary:
Antibacterial drugs are facing increasing limitations in terms of effectiveness due to emergence resistance. Improved antibacterial drug monitoring approaches are particularly needed in nosocomial infections occurring in ICU patients, including ventilator-associated pneumonia and ventilator-associated tracheobronchitis, where decreased susceptibility of the etiological organisms is observed worldwide and pharmacokinetic alterations frequently observed.

No routine drug monitoring is available for betalactams at the point of care in a useful time frame (i.e., within a few hours after having collected the blood specimens).

The purpose of this study is to compare MON4STRAT approach for reaching and maintaining a meropenem pre-determined PK-PD target when compared to conventional meropenem dose.


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Limb-Girdle Muscular Dystrophy 2I

summary: Prospective, longitudinal, interventional, single-group, multicenter natural history study to better know the LGMD2I disease physiopathology. The duration of participation for each patient will be up to 24 months.

lead_sponsor: Genethon

location_country:
Denmark
United Kingdom
France

location_facility:
Pr Volker Straub
Pr John Vissing
Dr Tanya Stojkovic


title: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment

summary: Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.

lead_sponsor: Bioprojet

location_country:
Russian Federation
France
Bulgaria

location_facility: State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism


title: A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

acronym: PIONEER

summary: The objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called GS030-DP (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called GS030-MD (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis Pigmentosa

lead_sponsor: GenSight Biologics

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

location_facility: Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

intervention_type: Combination Product


title: A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.

summary: The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

ReferenceCitation: Eastwood PR, Barnes M, MacKay SG, Wheatley JR, Hillman DR, Nguyên XL, Lewis R, Campbell MC, Pételle B, Walsh JH, Jones AC, Palme CE, Bizon A, Meslier N, Bertolus C, Maddison KJ, Laccourreye L, Raux G, Denoncin K, Attali V, Gagnadoux F, Launois SH. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020 Jan 9;55(1). pii: 1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan.

family: Eastwood

full_name: Peter R. Eastwood

given: Peter R.

family: Barnes

full_name: Maree Barnes

given: Maree

family: MacKay

full_name: Stuart G. MacKay

given: Stuart G.

family: Wheatley

full_name: John R. Wheatley

given: John R.

family: Hillman

full_name: David R. Hillman

given: David R.

family: Nguyên

full_name: Xuân-Lan Nguyên

given: Xuân-Lan

family: Lewis

full_name: Richard Lewis

given: Richard

family: Campbell

full_name: Matthew C. Campbell

given: Matthew C.

family: Pételle

full_name: Boris Pételle

given: Boris

family: Walsh

full_name: Jennifer H. Walsh

given: Jennifer H.

family: Jones

full_name: Andrew C. Jones

given: Andrew C.

family: Palme

full_name: Carsten E. Palme

given: Carsten E.

family: Bizon

full_name: Alain Bizon

given: Alain

family: Meslier

full_name: Nicole Meslier

given: Nicole

family: Bertolus

full_name: Chloé Bertolus

given: Chloé

family: Maddison

full_name: Kathleen J. Maddison

given: Kathleen J.

family: Laccourreye

full_name: Laurent Laccourreye

given: Laurent

family: Raux

full_name: Guillaume Raux

given: Guillaume

family: Denoncin

full_name: Katleen Denoncin

given: Katleen

family: Attali

full_name: Valérie Attali

given: Valérie

family: Gagnadoux

full_name: Frédéric Gagnadoux

given: Frédéric

family: Launois

full_name: Sandrine H. Launois

given: Sandrine H.

journal_name: European Respiratory Journal

repository_institution: University of Melbourne - Minerva Access

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

repository_institution: University of Wollongong - Research Online

location_facility: Royal National Throat, Nose and Ear Hospital - London

location_facility: Hollywood Private UWA Centre for Sleep Science Facility


title: Drug Utilization Study for Olodaterol

summary: This study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.

time_perspective: Cross-Sectional

lead_sponsor: Boehringer Ingelheim

location_country: Denmark France Netherlands

location_facility:
Pharmo Institute
Aarhus Universitetshospital Skejby
IMS Health Information solutions


title: MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC)

acronym: MOBIDIC

summary:
The study is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools.

At this time, this study has no impact neither on treatment nor on disease diagnostic, these will be based on usual medical practices and is no investigational product associated with the conduct of this study.

lead_sponsor: Enterome

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


title: REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety

acronym: REPRISE EDGE

summary: The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

lead_sponsor: Boston Scientific Corporation

location_country: Denmark Sweden France

location_facility:
Rigshospitalet
Clinique Pasteur
Skåne University Hospital


title: A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation

summary: The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.

ReferenceCitation: Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.

name: Department of Cardiology St. Antonius Hospital Nieuwegein The Netherlands

name: Department of Cardiology Amsterdam University Medical Centers  The Netherlands

family: Klaver

full_name: Martijn N. Klaver

given: Martijn N.

name: Department of Cardiology Onze‐Lieve‐Vrouw Ziekenhuis Aalst Belgium

family: De Potter

full_name: Tom J. R. De Potter

given: Tom J. R.

family: Iliodromitis

full_name: Konstantinos Iliodromitis

given: Konstantinos

name: Adagio Medical Laguna Hills California USA

family: Babkin

full_name: Alexander Babkin

given: Alexander

family: Cabrita

full_name: David Cabrita

given: David

family: Fabbricatore

full_name: Davide Fabbricatore

given: Davide

family: Boersma

full_name: Lucas V. A. Boersma

given: Lucas V. A.

journal_name: Journal of Cardiovascular Electrophysiology

oa_colors: green hybrid

evidence: open (via crossref license)

title: Ultralow temperature cryoablation using near‐critical nitrogen for cavotricuspid isthmus‐ablation, first‐in‐human results

lead_sponsor: Adagio Medical

location_country: Belgium France Netherlands

location_facility:
OLV Hospital
Cardiology Hospital of Haut-Lévêque
St. Antonius Hospital


title: Phase III Multicentric Study Evaluating the Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care

summary:
The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular organisations.

The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.

lead_sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_country: Germany Belgium France

location_facility: Cliniques Universitaires Saint-Luc, Université Catholique de Louvain Bruxelles


title: A First-in-human Phase 1 Dose Escalation Study of SAR428926 in Patients With Advanced Solid Tumors

summary:
Primary Objectives:

To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors.

To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926

Secondary Objectives:

To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites.

To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients.

To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).

lead_sponsor: Sanofi

location_country: Denmark France Spain

location_facility:
Investigational Site Number 2500001
Investigational Site Number 7240001
Investigational Site Number 2080001


title: Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm

acronym: OWED

summary: Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a patient is ready to be weaned from the ventilator based on breathing pattern measurements. The T-piece technique allows clinicians to calculate breathing patterns accurately but many prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern. The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt) supposedly represents what the patient really wants: without disconnecting the patient from the ventilator, it may be possible to determine what is the real need and whether the patient is able to maintain Vt without support. The aims of the study are as follows: to test whether the changes in Vt after the removal of a standardized level of NAVA assistance (ΔVt) can predict weaning outcome; to compare the proposed titration of effort in NAVA (occlusion) with Patient-Ventilator Breath Contribution (PVBC) and titration using the Pmusc/Eadi index (PEI) relating the pressure generated by the respiratory muscles (muscular pressure; Pmusc) to the electrical activity of the diaphragm (EAdi); to assess the effect of PEEP on the change in Vt; and to evaluate EAdi after extubation. Patients ventilated for at least 24 hours who are ready to undergo an SBT will be included. Patients younger than 18 years of age and/or who have a contraindication to NAVA catheter insertion and/or surgical patients expected to be extubated within 12 hours will be excluded. After a baseline inclusion period with the pre-enrollment mode of ventilation, the standardized NAVA level will be applied for 20 minutes, during which both Patient-Ventilator Breath Contribution (PVBC) and PEI will be calculated. After the NAVA trial, a period of Continuous Positive Airway Pressure (CPAP) 5 (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both with NAVA gain 0) will be performed in order to record the difference with Vt during standardized NAVA (ΔVt). At the end of this period, the patient will be switched back to the baseline settings for 30 minutes-3 hours. After this period, the patient will perform an SBT with CPAP 0 or CPAP 5 for 1 hour. At the end of the SBT, the attending physician will decide whether or not to extubate the patient according to standard criteria and blinded to the ΔVt results. Ultimately, patients will be classified as "success" or "failure" and the ΔVt will be compared between these two groups.

ReferenceType: background

ReferenceCitation: Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50.

ReferenceCitation: Bellani G, Mauri T, Coppadoro A, Grasselli G, Patroniti N, Spadaro S, Sala V, Foti G, Pesenti A. Estimation of patient's inspiratory effort from the electrical activity of the diaphragm. Crit Care Med. 2013 Jun;41(6):1483-91. doi: 10.1097/CCM.0b013e31827caba0.

lead_sponsor: Unity Health Toronto

location_country: Italy Canada France

location_facility: Azienda Ospedaliero - Universitaria OORR Ospedali Riuniti di Foggia


lead_sponsor: Ferring Pharmaceuticals

location_country: Germany Finland France

location_facility: Tampereen yliopistollinen sairaala (there may be other sites in this country)

location_facility: Universitaetsklinikum Freiburg (there may be other sites in this country)

location_facility: Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)

title: A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

summary: The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.


title: Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

acronym: COMETE

summary: The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

ReferenceCitation: Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.

family: Dupont

full_name: Christophe Dupont

given: Christophe

family: Bradatan

full_name: Elena Bradatan

given: Elena

family: Soulaines

full_name: Pascale Soulaines

given: Pascale

family: Nocerino

full_name: Rita Nocerino

given: Rita

family: Berni-Canani

full_name: Roberto Berni-Canani

given: Roberto

journal_name: BMC Pediatrics

title: Tolerance and growth in children with cow’s milk allergy fed a thickened extensively hydrolyzed casein-based formula

lead_sponsor: United Pharmaceuticals

location_country: Italy Belgium France

location_facility:
Centre Hospitalier Régional
University of Naples Federico II
Necker Children's Hospital

intervention_type: Dietary Supplement


title: Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases

acronym: METACARDIS

summary: Supported by state-of-the-art systems medicine competences including integrative computational and functional genomics, the overarching goal of the trial is to investigate the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective will be to translate the clinical and fundamental based discoveries into new diagnosis and preventive actions paving the way to novel modes of treatment in the successive stages of CMD progression.

primary_purpose: Screening

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Denmark Germany France

location_facility:
University of Leipzig
Hôpital Pitié-Salpétrière
University of Copenhagen


title: Assessment of an Enhanced Version of a Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor-2) for Diabetic Patients Treated by Basal-Bolus Insulin Regimens

summary: The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.

lead_sponsor: University Hospital, Montpellier

location_country: Italy France Czechia

location_facility: Institute for Clinical and Experimental Medicine


title: Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations

summary:
Interactive games (virtual reality) have recently been the center of interest and scientific discussion in the field of cognitive and functional rehabilitation. From their entertaining and contextual aspects, off-the-shelf video games are potentially interesting tools as adjunct to the patient care, especially for maintaining instrumental activities of daily living (IADL) autonomy.

Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing health related quality of life (HRQL). This decrease in cognitive and functional abilities can be slowed down using adapted rehabilitation program.

However, there is no randomized controlled study comparing usual physical therapy to virtual reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect.

Off-the-shelf gaming consoles offer a large range of games where cognitive and functional abilities from geriatric patients could be stimulated and consequently HRQL improved.

However, a better knowledge of the potential cognitive and functional improvement processes from virtual reality rehabilitation in institutional routine is needed to enhance the quality and the range of the available care in old adults.

This study will not only be a validation platform of virtual reality as stand alone rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming consoles in HRQL improvement of old adults.

The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL changes of patients with Alzheimer disease and related disorders.

•Method

This study is a randomized controlled trial that comprises two study phases :

Phase one; comparing three parallel groups where therapists and assessors will be kept blind of study objectives, and Phase two, the investigators will take the most cost-effective gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will use it as an adjunct to physical therapy compared to physical therapy alone, with respect to the same amount of rehabilitation time.

The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after intervention.

Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or physical therapy as the 'gold' standard condition.

All groups will receive the same amount of rehabilitation time. Power and sample calculation for phase two will be based on phase one results.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Australia France Netherlands

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

location_facility: Radboud University Nijmegen Medical Centre

intervention_type: Behavioral


summary: This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.

lead_sponsor: Allergan

location_country:
United States
France
Netherlands


title: Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial

acronym: AMEP

summary: The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man.

lead_sponsor: Onxeo

location_country: Denmark Slovenia France

location_facility:
Institute of Oncology Ljubljana
Gustave Roussy Institute
Copenhagen University Hospital Herlev


title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

summary: This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC patients.

lead_sponsor: Genentech, Inc.


title: A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally in Adult Patients With Advanced Solid Malignancies

summary: This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.

lead_sponsor: Novartis Pharmaceuticals

location_country: Canada France Spain


title: An Open-label, Phase I, Dose-escalation Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors and Non-hodgkin's Lymphoma

summary: This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.

location_country:
United States
United Kingdom
France


title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

summary: Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.

ReferenceCitation: Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Rekhtman G, Masliak Z, Robak P, Esseltine DL, Feng H, Deraedt W, van de Velde H, Arnulf B. Subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma: subanalysis of patients with renal impairment in the phase III MMY-3021 study. Haematologica. 2015 May;100(5):e207-10. doi: 10.3324/haematol.2014.118182. Epub 2015 Jan 16.

family: Moreau

full_name: P. Moreau

given: P.

family: Pylypenko

full_name: H. Pylypenko

given: H.

family: Grosicki

full_name: S. Grosicki

given: S.

family: Karamanesht

full_name: I. Karamanesht

given: I.

family: Leleu

full_name: X. Leleu

given: X.

family: Rekhtman

full_name: G. Rekhtman

given: G.

family: Masliak

full_name: Z. Masliak

given: Z.

family: Robak

full_name: P. Robak

family: Esseltine

full_name: D.-L. Esseltine

family: Feng

full_name: H. Feng

family: Deraedt

full_name: W. Deraedt

given: W.

family: van de Velde

full_name: H. van de Velde

family: Arnulf

full_name: B. Arnulf

given: B.

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, Rekhtman G, Masliak Z, Robak T, Shubina A, Arnulf B, Kropff M, Cavet J, Esseltine DL, Feng H, Girgis S, van de Velde H, Deraedt W, Harousseau JL. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011 May;12(5):431-40. doi: 10.1016/S1470-2045(11)70081-X. Epub 2011 Apr 18. Erratum in: Lancet Oncol. 2011 Jun;12(6):522.

full_name: Philippe Moreau

given: Philippe

full_name: Halyna Pylypenko

given: Halyna

full_name: Sebastian Grosicki

given: Sebastian

full_name: Ievgenii Karamanesht

given: Ievgenii

location_facility: Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU

location_facility: Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33

location_facility: UZ Brussel Department Medical Oncology Laarbeeklaan 101


title: A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas

summary: There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares

lead_sponsor: LEO Pharma

location_country:
Canada
United Kingdom
France

location_facility:
Hôpital de l'Archet
Probity Medical Research
Ninewells Hospital & Medical School


title: An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)

summary: The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.

location_country:
United States
France
Spain


title: A Randomized, Double-blind, Placebo-controlled, 4 Period Incomplete Block Cross-over, Multi-center, Multiple Dose (7 Days) Dose-ranging Study to Assess the Efficacy and Safety of 4 Doses of NVA237 in Patients With Stable COPD, Compared to Seven Days Treatment With Tiotropium (18μg Once Daily, Open Label) as an Active Control

summary: This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.

ReferenceCitation: Verkindre C, Fukuchi Y, Flémale A, Takeda A, Overend T, Prasad N, Dolker M. Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Respir Med. 2010 Oct;104(10):1482-9. doi: 10.1016/j.rmed.2010.04.006. Epub 2010 Jun 11.

family: Verkindre

full_name: C. Verkindre

given: C.

family: Fukuchi

full_name: Y. Fukuchi

given: Y.

family: Flémale

full_name: A. Flémale

given: A.

family: Takeda

full_name: A. Takeda

family: Overend

full_name: T. Overend

given: T.

family: Prasad

full_name: N. Prasad

given: N.

family: Dolker

full_name: M. Dolker

given: M.

journal_name: Respiratory Medicine

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country: Belgium France Japan

location_facility:
Novartis Investigator site
Novartis Investigator Site


title: Efficacy and Safety of R-hLH (Luveris ®) Priming Prior to R-HFSH Treatment in Infertile Women Undergoing IVF-ET

summary:
In programmes of IVF, normal women undergo controlled ovarian stimulation using exogenous FSH injections to obtain multiple eggs. The process results in eggs of mixed quality with a broad range of developmental and implantation potential.

The aim of the study was to determine whether, treatment with recombinant human LH prior to the FSH injections can improve outcome for women undergoing IVF. High grade embryos implant with a higher frequency and baby delivery rate than poor quality embryos. The mature oocyte is the most important determinant of embryo quality. Early follicles, containing immature eggs, have LH receptors in the theca cells that surround the follicle, and LH stimulates these cells to produce factors essential for normal follicular development.

The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of follicles, so that they can all mature together, thus increasing the proportion of high grade oocytes and their subsequent embryos

ReferenceCitation: Durnerin CI, Erb K, Fleming R, Hillier H, Hillier SG, Howles CM, Hugues JN, Lass A, Lyall H, Rasmussen P, Thong J, Traynor I, Westergaard L, Yates R; Luveris Pretreatment Group. Effects of recombinant LH treatment on folliculogenesis and responsiveness to FSH stimulation. Hum Reprod. 2008 Feb;23(2):421-6. Epub 2007 Dec 15.

lead_sponsor: NHS Greater Glasgow and Clyde

location_country:
Denmark
United Kingdom
France

location_facility: Reproductive Medicine Unit, Department of Gynaecology and Obstetrics, Jean Verdier Hospital, University Paris XIII

location_facility: Assisted Conception Unit., Royal Infirmary of Edinburgh

location_facility: Fertility Clinic, Department of Obstetrics and Gynaecology, University Hospital of Odense, 5000

intervention_type: Procedure


title: A Phase II Study of Cloretazine® (VNP40101M) for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia

summary:
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.

lead_sponsor: Vion Pharmaceuticals

location_facility: Jonsson Comprehensive Cancer Center at UCLA


title: A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

summary: Comparison of rituximab versus Iodine I 131 Tositumomab Therapeutic Regimen (Tositumomab and Iodine I 131 Tositumomab or the Bexxar Therapeutic Regimen, formerly called Iodine-131 Anti-B1 Antibody) in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0.18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day 2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the "therapeutic dose," subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.

ReferenceCitation: Quackenbush RC, Horner TJ, Williams VC, Giampietro P, Lin TS. Patients with relapsed follicular lymphoma treated with rituximab versus tositumomab and iodine I-131 tositumomab. Leuk Lymphoma. 2015 Mar;56(3):779-81. doi: 10.3109/10428194.2014.927461. Epub 2014 Jul 23.

family: Quackenbush

full_name: Robert C. Quackenbush

given: Robert C.

family: Horner

full_name: Thierry J. Horner

given: Thierry J.

family: Williams

full_name: Vanessa C. Williams

given: Vanessa C.

family: Giampietro

full_name: Patricia Giampietro

given: Patricia

family: Lin

full_name: Thomas S. Lin

given: Thomas S.

journal_name: Leukemia & Lymphoma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

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.

lead_sponsor: GlaxoSmithKline


title: Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes

acronym: ADAPT

summary: This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

ReferenceType: result

ReferenceCitation: Le Floch JP, Lévy M, Mosnier-Pudar H, Nobels F, Laroche S, Gonbert S, Eschwege E, Fontaine P; Assessment of Detemir Administration in Progressive Treat-to-Target Trial (ADAPT) Study Group. Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT). Diabetes Care. 2009 Jan;32(1):32-7. doi: 10.2337/dc08-0332. Epub 2008 Oct 22.

family: Le Floch

full_name: J.-P. Le Floch

family: Levy

full_name: M. Levy

family: Mosnier-Pudar

full_name: H. Mosnier-Pudar

given: H.

family: Nobels

full_name: F. Nobels

given: F.

family: Laroche

full_name: S. Laroche

given: S.

family: Gonbert

full_name: S. Gonbert

family: Eschwege

full_name: E. Eschwege

given: E.

family: Fontaine

full_name: P. Fontaine

given: P.

name: The Assessment of Detemir Administration in a Progressive Treat-to-Target Trial (ADAPT) Study Group

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Comparison of Once- Versus Twice-Daily Administration of Insulin Detemir, Used With Mealtime Insulin Aspart, in Basal-Bolus Therapy for Type 1 Diabetes: Assessment of Detemir Administration in a Progressive Treat-To-Target Trial (ADAPT)

lead_sponsor: Novo Nordisk A/S

location_country: Luxembourg Belgium France


title: Phase I Study of Lonafarnib (SCH66336) in Combination With Herceptin Plus Paclitaxel in HER 2 NEU Overexpressing Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining lonafarnib and trastuzumab with paclitaxel may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with trastuzumab and paclitaxel in treating patients with HER2/neu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.

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

location_country: Belgium France Netherlands

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital