title: Status Epilepticus in the Critically Ill Patients

summary:
Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus prospective registry.

Data collection using a standardized form : demographic data and data related to the SE, including circumstances of onset, dates and times of onset and of seizure control, on-scene clinical findings, clinical features of the seizures, pre-hospital and hospital care providers, timing of antiepileptic and supportive treatments, results of etiological investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview.

ReferenceCitation: Jacq G, Chelly J, Quenot JP, Soulier P, Lesieur O, Beuret P, Holleville M, Bruel C, Bailly P, Sauneuf B, Sejourne C, Rigaud JP, Galbois A, Arrayago M, Plantefeve G, Stoclin A, Schnell D, Fontaine C, Perier F, Bougouin W, Pichon N, Mongardon N, Ledoux D, Lascarrou JB, Legriel S. Multicentre observational status-epilepticus registry: protocol for ICTAL. BMJ Open. 2022 Feb 15;12(2):e059675. doi: 10.1136/bmjopen-2021-059675.

repository_institution: University of Liège - Open Repository and Bibliography

repositories:
HAL
PubMed Central
orbi.ulg.ac.be

repositories_concat: HAL;PubMed Central;orbi.ulg.ac.be

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

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

publisher_dissemination: British Medical Journal

lead_sponsor: Ictal Group

sponsor_collaborators:
Ictal Group
Versailles Hospital

location_facility: Intensive Care Unit - Versailles Hospital

location_facility: CH Brive La Gaillarde - Service de réanimation - USC

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive

location_facility: CH Angouleme - Service de réanimation polyvalente

location_facility: CH de Bethune - Service de Réanimation et Surveillance continue

location_facility: CH Public du Cotentin - Service de Réanimation - Médecin intensive

location_facility: Centre hospitalier de Roanne - Service de Réanimation - Soins continus

location_facility: Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire

location_facility: Centre Hospitalier Universitaire Régional

location_facility: CH de La Rochelle - Service de réanimation - USC

location_facility: CH de Beauvais - Service de réanimation polyvalente

location_facility: Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: HP Claude Galien - Service de Réanimation Polyvalente

location_facility: Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale


type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial

acronym: ESPRIT

summary:
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression.

Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Chun TW, Engel D, Mizell SB, Hallahan CW, Fischette M, Park S, Davey RT Jr, Dybul M, Kovacs JA, Metcalf JA, Mican JM, Berrey MM, Corey L, Lane HC, Fauci AS. Effect of interleukin-2 on the pool of latently infected, resting CD4+ T cells in HIV-1-infected patients receiving highly active anti-retroviral therapy. Nat Med. 1999 Jun;5(6):651-5. doi: 10.1038/9498.

ReferenceCitation: Connors M, Kovacs JA, Krevat S, Gea-Banacloche JC, Sneller MC, Flanigan M, Metcalf JA, Walker RE, Falloon J, Baseler M, Feuerstein I, Masur H, Lane HC. HIV infection induces changes in CD4+ T-cell phenotype and depletions within the CD4+ T-cell repertoire that are not immediately restored by antiviral or immune-based therapies. Nat Med. 1997 May;3(5):533-40. doi: 10.1038/nm0597-533.

ReferenceCitation: Emery S, Abrams DI, Cooper DA, Darbyshire JH, Lane HC, Lundgren JD, Neaton JD; ESPRIT Study Group. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT. Control Clin Trials. 2002 Apr;23(2):198-220. doi: 10.1016/s0197-2456(01)00179-9.

ReferenceType: result

ReferenceCitation: Arduino RC, Nannini EC, Rodriguez-Barradas M, Schrader S, Losso M, Ruxrungtham K, Allende MC, Emery S, Fosdick L, Neaton J, Tavel JA, Davey RT, Lane HC; Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) Vanguard Group; ESPRIT Executive Committee. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies. Clin Infect Dis. 2004 Jul 1;39(1):115-22. doi: 10.1086/421775. Epub 2004 Jun 14.

ReferenceCitation: INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee; Abrams D, Levy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. Interleukin-2 therapy in patients with HIV infection. N Engl J Med. 2009 Oct 15;361(16):1548-59. doi: 10.1056/NEJMoa0903175.

ReferenceType: derived

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

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)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: SAGE Publications

ReferenceCitation: Nordell AD, McKenna M, Borges AH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Mocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. doi: 10.1371/journal.pone.0040245. Epub 2012 Jul 20.

ReferenceCitation: Pett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miro JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT). HIV Med. 2011 Apr;12(4):219-27. doi: 10.1111/j.1468-1293.2010.00875.x. Epub 2010 Aug 31.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

sponsor_collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Canada
France
Portugal
Denmark
Switzerland
United States
Morocco
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Spain
Israel

location_facility: Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS

location_facility: Hosp. Juan Canalejo, Dept. of Internal Medicine CRS

location_facility: Kaplan Med. Ctr., Ben Ari Institute of Clinical Immunology CRS

location_facility: Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS

location_facility: C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS

location_facility: Cathedral Healthcare System, St. Michael's Med. Ctr. CRS

location_facility: Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS

location_facility: Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS

location_facility: The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS

location_facility: Hopital de Bicetre, Service de Medecine Interne CRS

location_facility: Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS

location_facility: Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS

location_facility: Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS

location_facility: The Early Intervention Program at Kennedy Hosp. CRS

location_facility: Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS

location_facility: Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS

location_facility: Legacy Community Health Services, Inc., Montrose Clinic, Inc.

location_facility: Hopital de La Salpetriere, Service de Medecine Interne CRS

location_facility: King's College Hosp., Caldecot Ctr. Dept. of Sexual Health CRS

location_facility: Hopital Sainte Marguerite, CISIH Hopital de Jour CRS

location_facility: UCSF PHP, Gen. Internal Medicine Practice CRS

location_facility: CHRU d'Angers, Service de Maladies Infectieuses CRS

location_facility: Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS

location_facility: Hopital Antoine Beclere Service d'Immunologie Clinique CRS

location_facility: Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS

location_facility: Western Gen. Hosp., Regional Infectious Diseases Unit CRS

location_facility: Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS

location_facility: Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS

location_facility: Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS

location_facility: Hopital de la Conception, Service des Maladies Infectieuses CRS

location_facility: Hosp. Gen. de Agudos Juan A. Fernandez CRS

location_facility: Hanover Med. Park (Mechanicsville, VA) CRS

location_facility: Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS

location_facility: Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS

location_facility: Univ. of Miami, Infectious Diseases Clinical Research Unit CRS

location_facility: Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS

location_facility: Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS

location_facility: Hopital Louis Mourier, Service de Medecine Interne CRS

location_facility: Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS

location_facility: Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS

location_facility: Windsor Regional Hosp., HIV Care Program CRS

location_facility: Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

location_facility: John Hunter Hosp., Immunology & Infectious Diseases Unit CRS

location_facility: Denver Infectious Diseases Consultants CRS

location_facility: Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS

location_facility: Univ. Hosp. Heidelberg, Dept. of Dermatology CRS

location_facility: Cairns Base Hosp., Sexual Health Services CRS

location_facility: McMaster Univ. Med. Ctr. Hamiton Health Sciences, SIS Clinic CRS

location_facility: Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS

location_facility: Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS

location_facility: Universita La Sapienza, Clinica Universita La Sapienza CRS

location_facility: Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS

location_facility: Hosp. 12 de Octubre, Pabellon de Medicina Communitaria CRS

location_facility: St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS

location_facility: St. George's Hosp. Clinical Infection UnitCRS

location_facility: OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS

location_facility: Royal London Hosp., Ambrose King Ctr. CRS

location_facility: Civili di Brescia, 1st Division of Infectious Diseases CRS

location_facility: Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS

location_facility: Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS

location_facility: Toronto Gen. Hosp. Infectious Diseases CRS

location_facility: Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS

location_facility: Hosp. Interzonal de Agudos San Juan de Dios CRS

location_facility: Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit CRS

location_facility: Virginia Commonwealth Univ. Medical Ctr. CRS

location_facility: Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS

location_facility: Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS

location_facility: Hopital Cochin, Service de Medecine Interne 2 CRS

location_facility: Hosp. la Princesa, Internal Medicine and Infectious Diseases Service CRS

location_facility: St. Joseph's Health Ctr. of London, HIV Care Programme CRS

location_facility: VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS

location_facility: Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

location_facility: SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS

location_facility: Hopital Avicenne, Service de Medecine B CRS

location_facility: Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS

location_facility: Hosp. Virgen del Rocio, Infectious Diseases Service CRS

location_facility: Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

location_facility: Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS

location_facility: Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS

location_facility: Northwestern Memorial Physicians Group CRS

location_facility: Hvidovre Univ. Hosp., Dept. of Infectious Diseases CRS

location_facility: Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS

location_facility: Hosp. del Mar, Internal Medicine-Infectious Diseases CRS

location_facility: Univ. of Tokyo, Research Hosp. of the Institute of Medical Science CRS

location_facility: Univ. of Alberta Hosp., Clinical Research Office CRS

location_facility: San Francisco VAMC, Infectious Diseases Clinic CRS

location_facility: CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS

location_facility: Hosp. Universitario Morales Meseguer CRS

location_facility: Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS

location_facility: Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici

location_facility: Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS

location_facility: Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS

location_facility: Univ. of Colorado Health Science Ctr. CRS

location_facility: Ulleval Hosp., Dept. of Infectious Diseases CRS

location_facility: Aalborg Hosp., Dept. of Infectious Diseases CRS

location_facility: Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS

location_facility: Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS

location_facility: Kaiser Immune Deficiency Clinic of Portland CRS

location_facility: Multnomah County Health Dept., HIV Health Services Ctr. CRS

location_facility: Univ. Hosp. Charite, Dept of Infectious Diseases CRS

location_facility: South Texas Veterans Health Care System, Immunosuppression Clinic CRS

location_facility: Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS

location_facility: William Beaumont Hosp., Infectious Disease Research CRS

location_facility: St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS

location_facility: New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

location_facility: Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS

location_facility: National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS

location_facility: Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS

location_facility: Tel Aviv Sourasky Med. Ctr., Clinical Immunology Unit and AIDS Ctr. CRS

location_facility: Royal Free Hosp., Dept. of Infection & Immunity, Ian Charleson Day Ctr. CRS

location_facility: Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS

location_facility: Rigshospitalet, Department of Infectious Diseases, M5112 CRS

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS

location_facility: Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS

location_facility: Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS

location_facility: Siriraj Hosp., Mahidol Univ. INSIGHT CRS

location_facility: Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion

location_facility: Edith Cavell Hosp. Dept. of Sexual Health, Clinic E CRS

location_facility: St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS

location_facility: Univ. of Illinois Family Ctr. for Infectious Disease CRS

location_facility: The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS

location_facility: Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS

location_facility: Lakeshore Infectious Disease Associates CRS

location_facility: Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS

location_facility: Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS

location_facility: Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

location_facility: Hosp. Severo Ochoa, Internal Medicine and Infectious Diseases CRS

location_facility: Abbott Northwestern Hosp., Clinic 42 CRS

location_facility: Hopital Foch, Service de Medecine Interne CRS

location_facility: Canberra Hosp., Canberra Sexual Health Clinic CRS

location_facility: Groningen Univ. Hosp., Department of Internal Medicine CRS

location_facility: Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS

location_facility: Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS

location_facility: Hopital Necker, Service des Maladies Infectieuses CRS

location_facility: Universita degli Studi di Modena e Reggio Emilia, Clinica delle Malattie Infettive e Tropicali CRS

location_facility: Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS

location_facility: Raritan Bay Med. Ctr., Perth Amboy Division CRS

location_facility: Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS

location_facility: Hospital de Cascais, HDDI, Departamento Medicina Interna CRS

location_facility: Chelsea & Westminster Hosp., St. Stephens Ctr. CRS

location_facility: Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS

location_facility: Hospital Nacional Professor Alejandro Posadas CRS

location_facility: St. Thomas' Hosp., Dept. of GU Medicine CRS

location_facility: St. Mary's Hosp. of London, Imperial College School of Medicine CRS

location_facility: Royal Hallamshire Hosp., Dept. of GU Medicine Communicable Diseases Unit CRS

location_facility: Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS

location_facility: Hopital Saint-Antoine, Service de Maladies Infectieuses CRS

location_facility: Royal Victoria Hosp., Montreal Chest Institute CRS

location_facility: Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS

location_facility: Hopital Henri Mondor, Immunopathologie Clinique CRS

location_facility: Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS

location_facility: San Matteo Hospital - University of Pavia, Division of Infectious and Tropical Diseases CRS

location_facility: Newcastle Gen. Hosp., Dept of Infection & Tropical Medicine CRS

location_facility: The Research & Education Group-Portland CRS

location_facility: Chonburi Regional Hosp., Dept. of Internal Medicine CRS

location_facility: George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS

location_facility: Osaka National Hosp. AIDS Ctr., Clinical Research Institute CRS

location_facility: Instituto de Infectologia Emilio Ribas CRS

location_facility: Univ. College London Med. School, Ctr. for Sexual Health & HIV Research CRS

location_facility: Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS

location_facility: Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS

location_facility: Hosp. Universitario Principe de Asturias CRS

location_facility: Positive Health Practice West/ Dr. Steve Deeks CRS

location_facility: Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

type: Other Identifier

title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Canada
France
Denmark
United States
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Tianjin Medical University General Hospital

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: First affiliated Hospital of Zhejiang University

location_facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari

location_facility: University of Texas Southwestern Medical Center

location_facility: Fujian Meidical University Union Hospital

location_facility: Institut de Cancerologie Strasbourg Europe (ICANS)

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: Shengjing Hospital of China Medical University

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Hospitais Integradaos da Gavea S/A - DF Star

location_facility: National Hospital Organization Mito Medical Center

location_facility: Università di Roma 'La Sapienza' - Ospedale Umberto 1°

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: First Affiliated Hospital of Guangxi Medical University

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Sint Antonius Ziekenhuis - Afd.Interne - INT

location_facility: Emory University - Winship Cancer Institute

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

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Klinika Hematologii i Transplantologii, UCK

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

status_simplified: Ongoing


title: A Prospective, Multinational Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMID, and CD38 Monoclonal Antibody Treatment

acronym: LocoMMotion

summary: The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Mateos MV, Weisel K, De Stefano V, Goldschmidt H, Delforge M, Mohty M, Cavo M, Vij R, Lindsey-Hill J, Dytfeld D, Angelucci E, Perrot A, Benjamin R, van de Donk NWCJ, Ocio EM, Scheid C, Gay F, Roeloffzen W, Rodriguez-Otero P, Broijl A, Potamianou A, Sakabedoyan C, Semerjian M, Keim S, Strulev V, Schecter JM, Vogel M, Wapenaar R, Nesheiwat T, San-Miguel J, Sonneveld P, Einsele H, Moreau P. LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma. Leukemia. 2022 May;36(5):1371-1376. doi: 10.1038/s41375-022-01531-2. Epub 2022 Mar 24.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ipd_sharing: No

lead_sponsor: Janssen-Cilag Ltd.

sponsor_collaborators:
Janssen-Cilag Ltd.
Legend Biotech

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Belgium
United States
Spain
Russian Federation
France

location_facility: Grand Hopital de Charleroi, site Notre Dame

location_facility: The Cancer Institute at St. Francis Hospital

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II

location_facility: North Shore Hematology Oncology Associates, P.C.

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Pa

location_facility: Oncology Institute of Hope and Innovation

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

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

location_facility: Washington University School of Medicine

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.

location_facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

intervention_type: Other


title: A Multi-center, Open-label, Phase 2 Study of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

acronym: ERASMM

summary: This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

study_start_date_type: Anticipated

status: Not yet recruiting

enrollment_type: Anticipated

lead_sponsor: European Myeloma Network

sponsor_collaborators:
European Myeloma Network
Pfizer

location_country: Finland Italy Norway Netherlands Greece France

location_facility: Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

location_facility: CHU Saint Eloi Département d'Hématologie Clinique

location_facility: A.O.U. Policlinico S. Martino - Ematologia

location_facility: CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

location_facility: Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)


summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Attikon University General Hospital of Attica

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

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: University of Miami Leonard M. Miller School of Medicine - SCCC

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

location_facility: Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Wisconsin Institutes for Medical Research

location_facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

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

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

title: A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

source: euctr

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

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Australia
Japan
Netherlands
Sweden
Belgium
United States
Korea, Republic of
Spain
Greece
France


title: Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

status: Recruiting

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Germany
France
Italy
Australia
Japan
United States
Korea, Republic of
Taiwan
Israel

location_facility: Keimyung University Dongsan Medical Center /ID# 247371

location_facility: Linkou Chang Gung Memorial Hospital /ID# 248145

location_facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585

location_facility: Fondazione IRCCS San Gerardo dei Tintori /ID# 247584

location_facility: National Cancer Center Hospital East /ID# 250317

location_facility: Pusan National University Yangsan Hospital /ID# 248489

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 250714

location_facility: National Cancer Center Hospital /ID# 250319

location_facility: The Chaim Sheba Medical Center /ID# 243207

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 248143

location_facility: Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671

location_facility: National Cheng Kung University Hospital /ID# 248142

location_facility: Asklepios Fachkliniken Muenchen-Gauting /ID# 248082

location_facility: Hadassah Medical Center-Hebrew University /ID# 243298

location_facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329

location_facility: Hokkaido University Hospital /ID# 250316

location_facility: Osaka International Cancer Institute /ID# 251507

location_facility: CHU Lille - Hôpital Albert Calmette /ID# 246263

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144

intervention_type: Biological


title: Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection

summary:
Infection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare.

The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients.

Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity.

Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients.

We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.

status: Unknown status

ipd_sharing: Undecided

location_country:
Colombia
Brazil
Mexico
United States
Spain
Egypt
France

location_facility: Jackson Memorial Health System; University of Miami, Miller School of Medicine

location_facility: Centre Hospitalier Universitaire Louis Mourier

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Fundación Valle del Lili, University Hospital

location_facility: Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée

location_facility: Centre Hospitalier Régional Universitaire de Brest

location_facility: Centre Hospitalier Universitaire Beaujon

location_facility: Centre Hospitalier Universitaire Hôpital Edouard Herriot

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Hospital Regional De Alta Especialidad Del Bajío

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Dijon

status_simplified: Unknown


acronym: RECITE

lead_sponsor: Amgen

summary: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

location_facility: SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary

location_facility: Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation

location_facility: Centro de Investigaciones Clínicas Clínica Viedma

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Omsk Regional Clinical Oncology Dispensary

location_facility: Specialized Hospital for Active Treatment of Oncology EAD

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: State Institution of Public Health Tambov Regional Oncology Dispensary

location_facility: Mid Florida Hematology and Oncology Centers PA

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

location_facility: Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

location_facility: State budget institution of public health Pyatigorsk oncology dispensary

location_facility: Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao

location_facility: The Center for Cancer and Blood Disorders

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

location_facility: Centro de Pesquisa da Serra Gaucha - Cepesg

location_facility: Grand River Regional Cancer Centre at Grand River Hospital

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Christus Highland Cancer Treatment Center

location_facility: Centro de Atencion e Investigacion Cardiovascular del Potosi Sc

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio

location_facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

location_facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region

location_facility: Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Izmir Ekonomi Universitesi Medical Point Hastanesi

location_facility: Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan

location_facility: Hospital Universitario Arnau de Vilanova Lleida

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real

location_facility: Centro de Diagnostico Investigacion y Tratamiento

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

location_facility: Leningrad Regional Oncology Dispensary na L D Roman

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Colorado West Healthcare System dba Grand Valley Oncology

location_facility: Cape Breton Cancer Centre, Nova Scotia Health Authority

location_facility: Hospital Clinico Universitario San Cecilio

location_facility: Transcarpathian Regional Clinical Oncological Dispensary

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Spitalul Clinic al Cailor Ferate Cluj Napoca

location_facility: Clinical hospital 2, Group of companies medsi

location_facility: Oncology and Hematology Associates of West Broward, PA

location_facility: Loema Instituto de Pesquisa Clinica e Consultores Ltda

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

title: RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Poland
Argentina
Brazil
Turkey
Canada
France
Colombia
Portugal
Hungary
United States
Ukraine
Romania
Peru
Italy
Austria
Mexico
Spain
Greece
Bulgaria
Russian Federation


summary: The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: University of Arkansas for Medical Sciences

location_facility: Emory University - Winship Cancer Institute

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: First Affiliated Hospital, SooChow University

location_facility: The 1St Affiliated Hospital of Medical College Zhejiang University

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

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

location_facility: Kobe City Medical Center General Hospital

title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

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

design_allocation: Non-Randomized

location_country:
Germany
Poland
Israel
Japan
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
France


title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

ReferenceCitation: Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martinez-Lopez J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Epub 2022 Jun 5.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Belgium
United States
China
Spain
Canada
France

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

location_facility: West China Hospital, Si Chuan University

location_facility: Shengjing Hospital of China Medical University

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: First affiliated Hospital of Zhejiang University

location_facility: Winship Cancer Institute Emory University

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Tianjin Medical University Cancer Institute and Hospital


title: A Phase 3 Open-label, Controlled, Randomised, Multi-centre Trial Comparing Imlifidase and Standard-of-care With Standard-of-care Alone in the Treatment of Severe Anti-GBM Antibody Disease (Goodpasture Disease)

summary: An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and standard of care (SoC) with SoC alone. All patients will remain in the trial for 24 months.

lead_sponsor: Hansa Biopharma AB

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
United States
Spain
Czechia
France

location_facility: University College London, Royal Free Hospital, Department of Renal Medicine

location_facility: University Hospital of Marseille, Nephrology - Renal transplantation service

location_facility: Charité Department of Nephrology and Intensive Care

location_facility: IRCCS S. Orsola - Malpighi University Hospital - Nephrology, Dialysis and Transplantation Unit (pav 15)

location_facility: Tenon Hospital, Renal intensive care unit

location_facility: Hammersmith Hospital, Renal medicine and centre for inflammatory diseases

location_facility: The Ohio State University Wexner Medical Center

location_facility: Uppsala University Hospital, Department of Medical Sciences, Renal Medicine

location_facility: UNC Kidney Center/Division of Nephrology & Hypertension

location_facility: ASST degli Spedali Civili di Brescia - SC Nefrologia

location_facility: CHU Grenoble Alpes - Michallon Hospital, Nephrology, Hemodialysis, Apheresis and Kidney Transplantation

location_facility: Universitaetsklinikum Erlangen - Medizinische Klinik 4

location_facility: Skåne University Hospital, Department of Nephrology

location_facility: LMU Klinikum, Medical Clinic IV / Department of Nephrology

location_facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Dept. of Vasculitis


title: Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL)

summary: First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

lead_sponsor: Cellectis S.A.

location_country:
United States
Spain
France

location_facility: Sarah Cannon - St. David South Austin Medical Center


title: Evaluation of Methods for Extrapolating or Estimating the Size of Children in Pediatric Intensive Care Compared With the Reference Method of the World Health Organization (WHO)

acronym: EvTaReaP

summary:
Size is a key data used daily by dietary teams; the paramedical team, nurse and diet are in charge of its measures.

In pediatric intensive care unit, a reliable size of the child must be obtained. It allows to realize:

a nutritional assessment based on the World Health Organization (WHO) nutritional indices such as the Body Mass Index (BMI), growth chart monitoring and other nutritional indices. Nutritional status should be assessed and followed in pediatric intensive care as it is correlated with the prognosis of children.
an estimate of the energy needs by calculation of the rest energy expenditure.
a calculation of the body surface, useful for drug prescription, evaluation of burn scores, calculation of water and energy requirements and indexing of hemodynamic and ventilatory data.

An error in size measurement results in an error in BMI, calculation of energy requirements, and body surface area.

The WHO has defined "gold standard" criteria for measuring height in children, distinguishing the less than two years in whom the size is measured strictly lengthened, using a metric, and the more than two years in which height is measured standing with a stadiometer. In the context of pediatric resuscitation, the criteria for WHO size measurement are difficult to meet (coma, sedation, respiratory assistance, catheter, monitoring, proclive position, etc.) compromising standing or rectitude required for measurements.

The child is a growing organism. Health book sizes and declarative sizes are not always up-to-date.

It is therefore important to overcome these difficulties by using estimating or extrapolation methods that are applicable and safe in pediatric intensive care unit.

Currently, in pediatric intensive care units, the size evaluation, by direct measurement, estimation or extrapolation of segmental measurement, is not systematic because of the complexity of the measurement; To date, no method is used as a reference method in pediatric intensive care.

Among Children in pediatric intensive care unit (which does not usually meet the criteria of the WHO Gold Standard for Measurement of Height), to determine the optimal method for size measurement, by comparing different methods of estimating / extrapolating the size, gold standard WHO (achievable after the stay in intensive care).

lead_sponsor: Hospices Civils de Lyon

location_country: Switzerland Lebanon Belgium France

location_facility: Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes

location_facility: Service de réanimation et de surveillance continue pédiatrique CHRU de Lille

location_facility: Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux

location_facility: Service de réanimation pédiatrique Rue Du Morvan (CHRU NANCY - HOPITAUX DE BRABOIS)

location_facility: Service de réanimation pédiatrique Hôpital de l'hôtel dieu de France

location_facility: Service de réanimation pédiatrique Hôpital cardiologique Louis Pradel

location_facility: Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique

location_facility: Service de réanimation pédiatrique CHU La Timone AP-HM

lead_sponsor_type: academique

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: EvTaReaP

titre: Evaluation des méthodes d'extrapolation ou d'estimation de la taille des enfants en réanimation pédiatrique par rapport à la méthode de référence de l'organisation mondiale de la santé (OMS).

discipline_principale: nutrition et obésité

nom_porteur: FORD CHESSEL

prenom_porteur: Carole


title: A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive and HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS(R) (Peginterferon Alfa-2a 40KD)

summary: This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

location_facility: Hospital de Sao Joao; Servico de Gastrenterologia

location_facility: Hopital Henri Mondor; Hepatologie Gastro Enterologie

location_facility: Centre Hospitalier Universitaire Ibn Sina; Service de Gastro-entérologie Essaid

location_facility: Medanta -The Medicity; Department of Digestive and Hepatobiliary Sciences

location_facility: Santosa Bandung International Hospital; Hepatology

location_facility: Nanjing No.2 Hospital; Liver Disease Department

location_facility: Hopital Cote De Nacre; Gastro Enterologie

location_facility: The Eighth People's Hospital of Guangzhou

location_facility: Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM

location_facility: Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

location_facility: Yehia Elshazly Clinic for Hepatology and Gastroentrology

location_facility: Hospital For Infectious Diseases; Infectiology

location_facility: Uni Heidelberg Med. Klinik; Innere Medizin IV

location_facility: Mitra International Jatinegara Hospital; Hepatology

location_facility: Bethune International Peace Hospital of PLA

location_facility: Inst. of Infectious & Parasitic Diseases; Clinic of Hepatology & Aquired Immunodeficiencies

location_facility: Cantonal Hospital Zenica; Department for Infective Diseases

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.

location_facility: Charité Universitätsmedizin Berlin; Campus Mitte, Centrum 12, Medizinische Poliklinik

location_facility: Universitaetsklinikum Essen, Innere Klinik und Poliklinik fuer Tumorforschung

location_facility: Hopital Saint Andre; Hepato-Gastro-Enterologie

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor; INFECTIOUS DISEASE

location_facility: Clinical Center Banja Luka; Department for Infective Diseases

location_facility: Hopital Jean Verdier; Gastro Enterologie

location_facility: University Clinical Center Tuzla; Clinic for Gastroenterology

location_facility: King Fahad Medical City; Gastroentrology

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Cantonal Hospital Bihac; Department for Infective Diseses

location_facility: Beijing 302 Hospital; No. 2 Infectious Disease Section

location_facility: Clinical Infectious Diseases Hospital Victor Babes

location_facility: Kyungpook National Uni Hospital; Internal Medicine

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: Salmaniya Medical Complex; Gastroenterology

location_facility: Hopital Hotel Dieu; Medecine Interne & D'Hepatologie

location_facility: Hopital de Pontchaillou; Medicine Interne - Hepatologie

location_facility: King Faisal Specialist Hospital & Research Centre; Oncology

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie

location_facility: Wojewodzki Szpital; Specjalistyczny Chorob Zakaznych

location_facility: Clinical Center Skopje; Gastroenterohepatology

location_facility: The Third Hospital of Hebei Medical University

location_facility: St.Marien-Hospital Klinik Knappenstraße Klinik f.Gastroenterologie

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Klinische Abt. Für Gaströnterologie & Hepatologie

location_facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik II

location_facility: CHU Hassan 2; Service Gastro Enterologie Pr IBRAHIMI

location_facility: Dr.med.Heiner W.Busch und Stefan Christensen

location_facility: Pomorskie Centrum Chorob Zakaznych i Gruzlicy

location_facility: Wojewódzki specjalistyczny szpital im. Bieganskiego; Oddział Obserwacyjno-Zakazny i Chorob Watroby

location_facility: Mhat Sveta Marina; Clinic of Gastroenterology

location_facility: Clinique De La Sauvegarde; Exploration Gastro Proctologie

location_facility: Shengjing Hospital of China Medical University

location_facility: Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

location_facility: Hopital Albert Michallon; Gastro Enterologie

location_facility: Dow University of Health Sciences; Department of Medicine

location_facility: Hopital Trousseau; Gastro Enterologie A Et B

location_facility: Mater Misericordiae University Hospital;Gastrointestinal Unit/Center for Liver Disease

location_facility: The 1st Affiliated Hospital of Harbin Medical University

location_facility: MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases

location_facility: Central Army Hospital Rspad Gatot Soebroto; Pulmonology

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 1

location_facility: Universitätsklinikum Bonn Med. Klinik u. Poliklinik I

location_facility: CH Pitie Salpetriere; Hepathologie Gastro Enterologie

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: Dres. Andreas Schaffert Andreas Trein und Edith Ißler u.w.

location_facility: Medizinische Universitätsklinik; Med. Klinik Ii, Infektiologie

location_facility: Prince Hamzeh Hospital; Internal Medicine

location_facility: Bintaro International Hospital, Hepatology

location_facility: Universitätsklinikum Münster Klinik und Poliklinik für Transplantationsmedizin

location_facility: Cipto Mangunkusumo General Hospital; Hematology & Oncology

location_facility: Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby

location_facility: Hull Royal Infirmary; Department Hepatology and Gastroenterology

location_facility: Klinikum rechts der Isar der TU München; II. Medizinische Klinik & Poliklinik

location_facility: Infektionsmedizinisches Centrum Hamburg ICH Grindel

location_facility: Hopital Emile Muller; Gastro Enterologie

location_facility: Wilhelminenspital; Iv. Medizinische Abt.

location_facility: Cantacuzino Clinical Hospital;Gastroenterology Department

location_facility: Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Hasan Sadikin Hospital; Digestive Surgery

location_facility: Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny

location_facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

location_facility: Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii

location_facility: Hospital Geral de Santo Antonio; Servico de Gastrenterologia

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

location_facility: Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I

location_facility: Hopital Nord; Reseau Hepatologie Picardie

location_facility: Dr. Soetomo Hospital; Kidney and Hipertansion

location_facility: Combined Military Hospital; Department of Medicine

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Institut Arnault Tzanck; Medecine I Gastro Enterologie

location_facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Hopital Antoine Beclere; Hepatologie Gastro Enterologie

location_facility: Hotel-Dieu de France Hospital; Gastroenterology

location_facility: St. Georges Uni of London; Gastroenterology & Hepatology

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie

location_facility: Clinical Hospital Mostar; Department for Gastroenterology

location_facility: American University of Beirut - Medical Center

location_facility: Ch Victor Dupouy; Hepato Gastro Medecine Interne

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: Medical Uni of Lodz; Infectious Diseases

location_facility: Hopital De La Conception; Gastro Enterologie Endoscopie 2E Nord

location_facility: The Hospital of Tropical and Infectious Disease Victor Babes

location_facility: überörtl.Gem.Praxis Dres. Stephan Dupke Axel Baumgarten

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Fondation Institut Arthur Vernes; Institut Arthur Vernes

location_facility: Holy Family Hospital; Department of Medicine

location_facility: Tuen Mun Hospital; Medicine & Geriatrics

location_facility: Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.

location_facility: Universitätsklinikum Klinik f. Gastroenterologie Hepatologie und Infektiologie

location_facility: Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia

location_facility: Songklanagarind Hospital; Division of Gastroenterology

location_facility: Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti

location_facility: Chiang Mai Uni Hospital; Faculty of Medicine

location_facility: North West Armed Forces Hospital; Internal Medicine

location_facility: Hopital Paul Brousse; Centre Hepatologie Biliaire

location_facility: Klinikum Salzgitter-Lebenstedt Medizinische Klinik I

location_facility: Medical Uni of Bialystok; Infectious Diseases

location_facility: Liver Clinic Lab-Aid Specialized Hospital

location_facility: Clinical Center Sarajevo; Gastroenterohepatology

location_facility: Hopital Charles Nicolle; Gastro Enterologie

location_facility: Hopital Jacques Monod; Gastro-Enterologie

location_facility: Ch De Lagny Sur Marne; Gastro Enterologie

location_facility: Hopitaux de Brabois - Gastro-Entereologie

location_facility: CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie

location_facility: King Fahad University Hospital; Internal Medicine

location_facility: Dres.Dietrich Hüppe Gisela Felten und Heinz Hartmann

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum

location_facility: Clinical Center Skopje; Infectious Diseases

location_facility: Universitätsklinikum S.-H. Campus Kiel Klinik für Innere Medizin I Gastroenterologie Hepotologie

location_facility: Sheikh Zayed Hospital; Department of Gastroentrology

location_facility: Ch Sud Francilien; Cons Gastro Enterologie

location_facility: University Clinical Center Tuzla; Clinic for Infective Diseases

location_facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

location_facility: NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: The Second Affiliated Hospital, Chongqing Medical University


title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

summary: The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

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

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Israel

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Oslo universitetssykehus HF, Rikshospitalet

location_facility: Attikon University General Hospital of Attica

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

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: University Hospitals Birmingham NHS Trust,

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: Chonnam National University Hwasun Hospital

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

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

location_facility: Medical University of Vienna,Universitätsklinik für Innere Medizin I

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

location_facility: New York Presbyterian-Weill Cornell Medical College

location_facility: Klinikum Großhadern der Ludwig-Maximilians-Universität

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie

location_facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Instituto Catalan Deoncologia Hospital Duran I Reynals

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole


acronym: MARCH-PFIC

lead_sponsor: Mirum Pharmaceuticals, Inc.

summary: The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).

location_facility: Hospital Papa Giovanni XXIII / Unità di Pediatria

location_facility: Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK)

location_facility: Hospices Civils de Lyon - Hopital Femme Mere Enfant Service de Gastroenterologie, Hepatologie et Nutrition

location_facility: Universite Catholique de Louvain (UCLouvain) - Cliniques Universitaires Saint-Luc

location_facility: The Children's Hospital at Montefiore Yeshiva University - Montefiore Medical Center

location_facility: University of Texas, Health Science Center San Antonio

location_facility: Consultario de Joshue David Covarrubias Esquer

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

location_facility: University of Texas - UT Southwestern Medical Center

location_facility: Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: University of Alberta - Women and Children's Health Research Institute

location_facility: Fundacion Cardioinfantil - Departamento de Investigaciones

title: MRX-502: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) - MARCH-PFIC

location_country:
Germany
Italy
Poland
Colombia
Hungary
Argentina
Singapore
United Kingdom
Brazil
Austria
Belgium
Lebanon
United States
Mexico
Turkey
Canada
France


title: Multicentre, Prospective, Randomized, Open-label, Assessor Blinded Study to Evaluate Granulox® Used as Adjunct Therapy to Defined Standard of Care vs. Defined Standard of Care for the Treatment of Predominantly Chronic Venous Leg Ulcers (VLUs)

summary:
The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation.

254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox added as an adjunct therapy in predominantly venous leg ulcer subjects. Standard of care wound management will be completed, including wound cleansing, debridement if necessary and application of a suitable dressing and compression system until complete wound closure.

The study will be divided into two phases. Firstly, a two week run-in period to ensure compliance to compression therapy followed by a 20 weeks treatment period starting with randomization and allocation of treatment.

lead_sponsor: Molnlycke Health Care AB

location_country:
Germany
Poland
Hungary
United Kingdom
Croatia
Czechia
France

location_facility: Markhot Ferenc oktatókórház és rendelöintézet

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik fuer Dermatologie

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Debreceni Egyetem, Klinikai Kozpont, Borgyogyaszati Klinika

location_facility: Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy Poradnia Leczenia Ran Przewleklych

location_facility: Department od Dermatology, Venerology and Allergology, University of Essen

intervention_type: Device


title: International Breast Cancer Intervention Study II (IBIS-II) (DCIS)

acronym: IBIS-II DCIS

summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.

ReferenceCitation: Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect. 2008 Sep;11(3):252-62. doi: 10.1111/j.1369-7625.2008.00498.x.

ReferenceCitation: Forbes JF, Sestak I, Howell A, Bonanni B, Bundred N, Levy C, von Minckwitz G, Eiermann W, Neven P, Stierer M, Holcombe C, Coleman RE, Jones L, Ellis I, Cuzick J; IBIS-II investigators. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. Lancet. 2016 Feb 27;387(10021):866-73. doi: 10.1016/S0140-6736(15)01129-0. Epub 2015 Dec 11.

ReferenceCitation: Sestak I, Smith SG, Howell A, Forbes JF, Cuzick J. Early participant-reported symptoms as predictors of adherence to anastrozole in the International Breast Cancer Intervention Studies II. Ann Oncol. 2018 Feb 1;29(2):504-509. doi: 10.1093/annonc/mdx713.

lead_sponsor: Queen Mary University of London

sponsor_collaborators:
Queen Mary University of London
Cancer Research UK

location_country:
Germany
Ireland
Italy
Hungary
United Kingdom
Australia
Sweden
Malta
Austria
Belgium
Switzerland
Turkey
Chile
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Royal Infirmary of Edinburgh at Little France

location_facility: Austrian Breast & Colorectal Cancer Study Group

location_facility: Leeds Cancer Centre at St. James's University Hospital

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

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Centre for Cancer Research and Cell Biology at Queen's University Belfast

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study

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 and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.

ReferenceCitation: Sorbye H, Mauer M, Gruenberger T, et al.: Predictive factors for the effect of perioperative FOLFOX for resectable liver metastasis in colorectal cancer patients (EORTC phase III study 40983). [Abstract] J Clin Oncol 28 (Suppl 15): A-3544, 2010.

ReferenceCitation: Sorbye H, Mauer M, Gruenberger T, et al.: Evaluation of carcinoembryonic antigen (CEA) as a predictive baseline factor for the benefit of perioperative FOLFOX in resectable liver metastasis from colorectal cancer (EORTC study 40983). [Abstract] American Society of Clinical Oncology 2010 Gastrointestinal Cancers Symposium, 22-24 January 2010, Orlando, Florida. A-407, 2010.

ReferenceCitation: Benoist S, Nordlinger B. The role of preoperative chemotherapy in patients with resectable colorectal liver metastases. Ann Surg Oncol. 2009 Sep;16(9):2385-90. doi: 10.1245/s10434-009-0492-7. Epub 2009 Jun 25.

ReferenceCitation: Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Praet M, Bethe U, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet. 2008 Mar 22;371(9617):1007-16. doi: 10.1016/S0140-6736(08)60455-9.

ReferenceCitation: Julie C, Lutz MP, Aust D, et al.: Pathological analysis of hepatic injury after oxaliplatin-based neoadjuvant chemotherapy of colorectal cancer liver metastases: results of the EORTC Intergroup phase III study 40983. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-241, 2007.

ReferenceCitation: Nordlinger B, Sorbye H, Collette L, et al.: Final results of the EORTC Intergroup randomized phase III study 40983 [EPOC] evaluating the benefit of peri-operative FOLFOX4 chemotherapy for patients with potentially resectable colorectal cancer liver metastases. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA5, 2007.

ReferenceCitation: Gruenberger T, Sorbye H, Debois M, et al.: Tumor response to pre-operative chemotherapy (CT) with FOLFOX-4 for resectable colorectal cancer liver metastases (LM). Interim results of EORTC Intergroup randomized phase III study 40983. [Abstract] J Clin Oncol 24 (Suppl 18): A-3500, 2006.

ReferenceCitation: Nordlinger B, Sorbye H, Debois M, et al.: Feasibility and risks of pre-operative chemotherapy (CT) with Folfox 4 and surgery for resectable colorectal cancer liver metastases (LM). Interim results of the EORTC Intergroup randomized phase III study 40983. [Abstract] J Clin Oncol 23 (Suppl 16): A-3528, 253s, 2005.

ReferenceCitation: Tanis E, Julie C, Emile JF, Mauer M, Nordlinger B, Aust D, Roth A, Lutz MP, Gruenberger T, Wrba F, Sorbye H, Bechstein W, Schlag P, Fisseler A, Ruers T. Prognostic impact of immune response in resectable colorectal liver metastases treated by surgery alone or surgery with perioperative FOLFOX in the randomised EORTC study 40983. Eur J Cancer. 2015 Nov;51(17):2708-17. doi: 10.1016/j.ejca.2015.08.014. Epub 2015 Sep 2.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.

ReferenceCitation: Sorbye H, Mauer M, Gruenberger T, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Van Cutsem E, Scheithauer W, Lutz MP, Nordlinger B; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK (CRUK); Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Predictive factors for the benefit of perioperative FOLFOX for resectable liver metastasis in colorectal cancer patients (EORTC Intergroup Trial 40983). Ann Surg. 2012 Mar;255(3):534-9. doi: 10.1097/SLA.0b013e3182456aa2.

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

collaborators: Arbeitsgruppe Lebermetastasen und Tumoren

collaborators: Fondation Francaise de Cancerologie Digestive

location_country:
Germany
Italy
Portugal
New Zealand
Norway
Hong Kong
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
France

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Ospedale San Martino/Cliniche Universitarie Convenzionate

location_facility: Institute of Oncology at Prince of Wales Hospital

location_facility: Robert Roessle Klinik at Charite - Campus Berlin Buch im Helios Klinikum Berlin

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Haukeland Hospital - University of Bergen

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Klinik der Justus - Leibig - Universitaet Giessen

location_facility: Queen Elizabeth Hospital at University of Birmingham

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

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

location_facility: Royal Liverpool and Broadgreen Hospitals

location_facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen


acronym: DOR/ISL in heavily treatment-experienced participants

lead_sponsor: Merck Sharp & Dohme LLC

summary: This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

location_facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603)

location_facility: Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502)

location_facility: Holdsworth House Medical Practice ( Site 5300)

location_facility: Azienda Ospedaliera San Paolo ( Site 5003)

location_facility: Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115)

location_facility: Mykolaiv center of paliative assistance and integrated services ( Site 5621)

location_facility: Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035)

location_facility: Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907)

location_facility: Saint Hope Foundation, Inc. ( Site 4034)

location_facility: ICH Study Center GmbH & Co.KG ( Site 4609)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 4715)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 4000)

location_facility: Centro Cardiovascular Cardiosur ( Site 4407)

location_facility: Regional Clinical Infectious Hospital ( Site 5614)

location_facility: Infectious Clinical Hospital #2 ( Site 5114)

location_facility: Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619)

location_facility: Severance Hospital Yonsei University Health System ( Site 5500)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001)

location_facility: CHU de Nice Hopital Archet 1 ( Site 4703)

location_facility: Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501)

location_facility: Ottawa Hospital Research Institute ( Site 4111)

location_facility: MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611)

location_facility: Pusan National University Hospital ( Site 5503)

location_facility: Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104)

location_facility: University of Alabama at Birmingham 1917 Research Clinic ( Site 4031)

location_facility: Triple O Research Institute, P.A. ( Site 4020)

location_facility: Toronto General Hospital - University Health Network ( Site 4105)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 4405)

location_facility: Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902)

location_facility: McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102)

location_facility: North Texas Infectious Diseases Consultants, PA ( Site 4005)

location_facility: Chatham County Health Department ( Site 4029)

location_facility: Holdsworth House Medical Practice - Brisbane ( Site 5312)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 4721)

location_facility: Monash Health-Monash Medical Centre ( Site 5313)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306)

location_facility: Georgetown University Hospital ( Site 4015)

location_facility: Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101)

location_facility: Centre Hospitalier de Tourcoing ( Site 4700)

location_facility: Medizinische Hochschule Hannover ( Site 4612)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 5401)

location_facility: Wits Clinical HIV Research Unit ( Site 4804)

location_facility: Ospedale San Gerardo ASST Monza ( Site 5012)

location_facility: Universita' Vita Salute. Ospedale San Raffaele ( Site 5002)

location_facility: Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 4714)

location_facility: Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113)

location_facility: Hopital Hotel Dieu [Paris, France] ( Site 4723)

location_facility: FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100)

location_facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005)

location_facility: MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 5600)

location_facility: Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620)

location_facility: Kyiv City Clinical Hospital 5 ( Site 5616)

location_facility: Universitaetsklinikum Essen ( Site 4607)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004)

location_facility: The University of Mississippi Medical Center ( Site 4036)

location_facility: Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905)

location_facility: Hospital Universitario La Paz ( Site 5604)

location_facility: Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106)

location_facility: Palmtree Clinical Research, Inc. ( Site 4016)

location_facility: Hospital Clinic i Provincial ( Site 5601)

location_facility: IRCCS Policlinico San Matteo ( Site 5010)

location_facility: Vancouver ID Research and Care Centre Society ( Site 4100)

location_facility: University of North Carolina at Chapel Hill ( Site 4026)

location_facility: Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006)

location_facility: Hospital Geral de Santo Antonio ( Site 4908)

title: A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL

location_country:
Germany
Italy
Colombia
Portugal
United Kingdom
Australia
Japan
United States
Korea, Republic of
Spain
South Africa
Chile
Peru
Canada
Ukraine
Puerto Rico
Russian Federation
France