title: Endurant CHevAr New Indication Trial: ENCHANT - Post-market Study of the Endurant CHEVAR Technique for the Treatment of Juxtarenal Aortic Aneurysms With a Short Infrarenal Neck

acronym: ENCHANT

summary: The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

lead_sponsor: Medtronic Cardiovascular

location_country:
Portugal
Spain
Ireland
Austria
Greece
Italy
Netherlands
Russian Federation
Switzerland
United Kingdom
Sweden
France
Germany
Slovakia

location_facility: Universitäts Klinikum Frankfurt - Goethe-Universität

location_facility: CHU de Bordeaux - Centre Universitaire Pellegrin

location_facility: Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Ordensklinikum Linz GmbH / Elisabethinen

location_facility: Corporacío Parc Taulí - Hospital de Sabadell

location_facility: Galway University Hospitals - University Hospital Galway (UHG)

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: Russian Cardiologic Research and Production Complex, Russian Ministry of Health

location_facility: St George's University Hospitals - NHS Trust


title: A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals With Mild COVID-19

summary:
Research Question: Does convalescent plasma (CCP) collected from donors who have recovered from COVID-19 and who have a very high titre of anti-SARS-CoV-2 antibodies reduce the risk of hospitalisation (for COVID-19) or death in patients with early symptoms of acute COVID-19 who are vulnerable to this disease compared to standard of care?
Study product: Very high antibody titre COVID-19 convalescent plasma collected more than 15 days after end of symptoms in COVID-19 patients who also had received at least one dose of a SARS-CoV-2 vaccine.
Methodology: Multicentre, randomised, open-label, adaptive superiority trial: COVID-19 very high neutralizing Ab titre convalescent plasma vs standard care in 2 cohorts of vulnerable patients (cohort 1: elderly (≥ 70 years) and younger with comorbidities, cohort 2: immunosuppressed patients).
Study phase: Phase 3
Intervention: Two units of high antibody titre COVID-19 convalescent plasma to individuals randomised to the intervention group, 2 units from 2 different donors, preferably transfused on the same day. Plasma provided by convalescent vaccinated donors with a minimum antibody titre of 1:640 against delta variant (B1.617.2) or antibody concentration >=4.000 BAU/ml in the QuantiVac anti-SARS-CoV-2 IgG ELISA or >=20.000 U/ml in the Elecsys anti-SARS-CoV-2 CLIA
Randomisation: 1:1 (standard of care + convalescent plasma vs. standard of care) stratified by centre (cohorts 1 and 2)

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

location_country:
Germany
France
Netherlands
United Kingdom

location_facility: Institut für Klinische Transfusionsmedizin (IKT)

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

summary: The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.

status: Enrolling by invitation

lead_sponsor: Mirum Pharmaceuticals, Inc.

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

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

location_facility: University of Texas, Health Science Center San Antonio

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

location_facility: Consultario de Joshue David Covarrubias Esquer

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

location_facility: Azienda Ospedaliera Papa Giovanni XXIII - Unita di Pediatria

location_facility: Groupement Hospitalier Est Hopital, Femme Mère Enfant de Lyon

location_facility: University of Texas Southwestern Medical Center

location_facility: Instytut Pomnik Centrum, Zdrowia Dziecka

intervention_type: Drug

status_simplified: Unknown


title: International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70

acronym: MyPeBS

summary:
MyPeBS is an international randomized, open-label, multicentric, study assessing the effectiveness of a risk-based breast cancer screening strategy (using clinical risk scores and polymorphisms) compared to standard screening (according to the current national guidelines in each participating country) in detecting stage 2 or higher breast cancers.

Women will be differentially screened for 4 years and then, after an end-of-study mammogram, they will return to the routine screening practice. The main study endpoint will be measured at the end of the four years of intervention.

Furthermore, follow up data will be collected for 15 years from study entry for evaluation of long-term cumulative breast cancer incidence and breast cancer-specific survival

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Roux A, Cholerton R, Sicsic J, Moumjid N, French DP, Giorgi Rossi P, Balleyguier C, Guindy M, Gilbert FJ, Burrion JB, Castells X, Ritchie D, Keatley D, Baron C, Delaloge S, de Montgolfier S. Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial. BMC Cancer. 2022 May 6;22(1):507. doi: 10.1186/s12885-022-09484-6.

ipd_sharing: Yes

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_country:
Spain
Italy
United Kingdom
France
Israel
Belgium

location_facility: Cambridge University Hospitals NHS Foundation Trust

intervention_type: Other


title: A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-Risk Early Stage Cervical Cancer (SHAPE)

acronym: SHAPE

summary: The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.

status: Active, not recruiting

enrollment_type: Actual

lead_sponsor: Canadian Cancer Trials Group

location_country:
United Kingdom
Ireland
Austria
Netherlands
Russian Federation
Canada
France
China
Belgium
Norway
Germany

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Clinique Mutualiste de la Sagesse - Rennes

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Universitaetsklinikum Hamburg - Eppendorf

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Klinikum der Universitaet Muenchen - LMU Campus Grosshadern

location_facility: CHUM-Centre Hospitalier de l'Universite de Montreal

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Hopital Europeen Georges Pompidou - Paris

location_facility: Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus

location_facility: Clinical Research Unit at Vancouver Coastal

location_facility: Institut Regional du Cancer de Montpellier

intervention_type: Procedure


type: Other Identifier

type: EudraCT Number

title: A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

summary: This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.

status: Terminated

study_completion_date_type: Actual

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panés J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2022 Jun 1. pii: izac063. doi: 10.1093/ibd/izac063. [Epub ahead of print]

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Poland
Serbia
Spain
Italy
Russian Federation
Netherlands
New Zealand
Canada
United Kingdom
Ukraine
Hungary
Korea, Republic of
France
United States
South Africa
Belgium
Japan
Germany
Slovakia
Czechia

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium

location_facility: Christus Trinity Mother Frances Endoscopy Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2

location_facility: Shiga University of Medical Science Hospital

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm

location_facility: North Shore Hospital (Waitemata District Health Board)

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Columbia University Irving Medical Center

location_facility: Christchurch Hospital (Canterbury District Health Board)

location_facility: London Health Sciences Centre - University Hospital

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Federal State Budgetary Institution "State Scientific Centre of Coloproctology

location_facility: Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak

location_facility: Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital

location_facility: Military Medical Academy, Clinic for Gastroenterology and Hepatology

location_facility: Gastro I., s.r.o., Gastroenterologicka ambulancia

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Columbia University Medical Center Research Pharmacy/ Milstein Hospital


title: A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

summary: The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

status: Completed

design_allocation: Non-Randomized

ReferenceCitation: Panés J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.

location_country:
Spain
Greece
Austria
Australia
Netherlands
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
South Africa
Japan
Germany
Bulgaria
Czechia

location_facility: Shands Hospital at the University of Florida

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: Department of medicine Shaare Zedek Medical Center

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Christus Trinity Mother Frances Endoscopy Center

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

location_facility: Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.

location_facility: Montreal General Hospital-Mcgill University Health Centre

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,

location_facility: Medical Clinical Research Center of Medical Center "Health Clinic" LLC

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Office of Drs. Ranjith Andrew Singh, Jamie D. Papp

location_facility: Gastroenterology Consultants of Clearwater

status_simplified: Completed


title: A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Phase 3 Pivotal Study to Assess the Safety and Efficacy of 1mg/kg/Day Intravenous DP-b99 Over 4 Consecutive Days Versus Placebo When Initiated Within Nine Hours of Acute Ischemic Stroke Onset

acronym: MACSI

summary: The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.

ReferenceType: background

ReferenceCitation: Diener HC, Schneider D, Lampl Y, Bornstein NM, Kozak A, Rosenberg G. DP-b99, a membrane-activated metal ion chelator, as neuroprotective therapy in ischemic stroke. Stroke. 2008 Jun;39(6):1774-8. doi: 10.1161/STROKEAHA.107.506378. Epub 2008 Apr 10.

ReferenceCitation: Rosenberg G, Angel I, Kozak A. Clinical pharmacology of DP-b99 in healthy volunteers: first administration to humans. Br J Clin Pharmacol. 2005 Jul;60(1):7-16.

ReferenceCitation: Barkalifa R, Hershfinkel M, Friedman JE, Kozak A, Sekler I. The lipophilic zinc chelator DP-b99 prevents zinc induced neuronal death. Eur J Pharmacol. 2009 Sep 15;618(1-3):15-21. doi: 10.1016/j.ejphar.2009.07.019. Epub 2009 Jul 19.

ReferenceCitation: Rosenberg G, Bornstein N, Diener HC, Gorelick PB, Shuaib A, Lees K; MACSI investigators. The Membrane-Activated Chelator Stroke Intervention (MACSI) Trial of DP-b99 in acute ischemic stroke: a randomized, double-blind, placebo-controlled, multinational pivotal phase III study. Int J Stroke. 2011 Aug;6(4):362-7. doi: 10.1111/j.1747-4949.2011.00608.x. Epub 2011 Jun 6.

ReferenceCitation: Rosenberg G, Marshall LS, Caraco Y. The neuroprotective agent DP-b99 does not interact with s-warfarin in vivo despite significant CYP2C9 inhibition in vitro. Basic Clin Pharmacol Toxicol. 2011 Apr;108(4):289-92. doi: 10.1111/j.1742-7843.2010.00654.x. Epub 2010 Dec 16.

lead_sponsor: D-Pharm Ltd.

location_country:
Poland
Brazil
Portugal
Spain
Italy
Austria
Netherlands
Canada
Czech Republic
Switzerland
Hungary
Korea, Republic of
United States
France
Israel
South Africa
Germany
Slovakia

location_facility: Fővárosi Önkormányzat Péterfy Sándor utcai Kórház- Rendelőintézet és Baleseti Központ

location_facility: Universitätsklinikum Erlangen, Neurologische klinik

location_facility: Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Neurologie

location_facility: Clinic of Neurology, Stroke Center, Charles University

location_facility: Memorial Health University Medical Center

location_facility: Neurologische Universitätsklinik Freiburg, Neurozentrum

location_facility: Klinikum der Otto-von-Guericke-Universität Magdeburg, Neurologische Universitätsklinik

location_facility: Pomerania Traumatology Center, Regional Specialist Hospital im. Nicolaus Copernicus

location_facility: The University of Kentucky The Methodist Hospital

location_facility: University of Louisville, Kentucky Neuroscience Research

location_facility: Vivantes Klinikum Neukölln, Klinik für Neurologie, Stroke Unit

location_facility: Hôpital Lariboisière - Service Neurologie

location_facility: Universitätsspital Zürich, Klinik für Neurologie

location_facility: Università di Roma "La Sapienza" - Stroke Unit

location_facility: Hospital Professor Doutor Fernando Fonseca, EPE

location_facility: Borsod-Abaúj-Zemplén County Hospital Miskolc

location_facility: Istituto Scientifico San Raffaele - Stroke Unit

location_facility: Dipartimento di Neuroscienze, Ospedale di Brotzu

location_facility: Szpital Powiatowy im. Marii Curie - Skłodowskiej w Skarżysku-Kamiennej

location_facility: Wojewodzki Szpital Specjalistyczny Nr 1 im. Prof. Jozefa Gasinskiego

location_facility: Kenezy Korhaz Rendelointezet Egezsegugyi Szolgaltato Nonprofit Kft.

location_facility: DRK Kliniken Berlin, Klinik fuer Neurologie

location_facility: Medisch Spectrum Twente Hoofd Afdeling Vasculaire Neurologie

location_facility: Medical University of Lublin, Department of Neurology, Stroke Unit

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

location_facility: Universitätsklinikum Ulm, Abteilung für Neurologie im RKU

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Capital Health Regional Medical Center Neuroscience Institute

location_facility: Johannes Gutenberg Universitat, Klinik und Poliklinik fur Neurologie

location_facility: Università di Perugia, Division of Internal and Cardiovascular Medicine - Stroke Unit

location_facility: Santa Casa de Misericórdia de Porto Alegre Policlinica Santa Clara Sala de Neurologia

location_facility: Hospital Clinico Universitario De Valladolid

location_facility: Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik

location_facility: Universitätsklinikum Essen, Klinik und Poliklinik für Neurologie

location_facility: Neurological Dept. Edith Wolfson Medical Center

location_facility: Azienda Ospedaliera Universitaria "Santa Maria della Misericordia" Stroke Unit

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Unidade de Emergência Centro de Estudos

location_facility: Klinikum Chemnitz GmbH Chefarzt Klinik für Neurologie

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Evangelische Kliniken Gelsenkirchen GmbH Klinik für Neurologie und Klinische Neurophysiologie

location_facility: Marien-Krankenhaus gGmbH, Abteilung für Neurologie

location_facility: Neurology Clinic, Faculty Hospital in Martin

location_facility: County Hospital Pardubice Clinic of Neurology

location_facility: Universität Rostock Chefarzt Abteilung Neurologie

location_facility: Wojskowy Instytut Medyczny, Oddział Neurologii

location_facility: Georg-August-Universitat Gottingen Neurologische Klinik

location_facility: Consorcio Hospital General Universitario Valencia

location_facility: Centro de Estudos Egas Moniz - Hospital de Santa Maria

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Seoul National University Bundang Hospital

location_facility: Klinikum Köln Merheim, Department of Neurology

location_facility: Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Sandomierzu

location_facility: Ärztlicher Direktor Neurologische Klinik, Neurologische Klink GmbH der Rhoen-Klinikum AG

location_facility: Hospitais da Universidadde de Coimbra, EPE

location_facility: Medical University of Warsaw, Department of Neurology

location_facility: Santa Casa de Misericordia de Belo Horizonte Departamento de Neurologia

location_facility: Instytut Psychiatrii i Neurologii Oddział Neurologiczny z Pododdziałem Udarowym

location_facility: University Hospital Hradec Kralove, Clinic of Neurology

location_facility: University Hospital Motol Clinic of Neurology

location_facility: Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Neurologii

location_facility: Azienda Ospedaliera Sant'Andrea, Stroke Unit


title: A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides

summary:
RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.

ReferenceCitation: Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. doi: 10.1111/j.1365-2133.2012.11156.x.

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

location_country:
Denmark
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Switzerland
Hungary
France
Israel
Belgium
Germany

location_facility: Royal Infirmary of Edinburgh at Little France

location_facility: Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Southwest German Cancer Center at Eberhard-Karls-University


acronym: PTCL

title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

lead_sponsor: Spectrum Pharmaceuticals, Inc

source: euctr

ReferenceType: result

ReferenceCitation: Campbell P, Thomas CM. Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. J Oncol Pharm Pract. 2017 Mar;23(2):143-147. doi: 10.1177/1078155216634178. Epub 2016 Jun 23.

location_country:
Denmark
Croatia
Poland
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
Hungary
United States
France
Israel
South Africa
Belgium
Germany
Slovakia

location_facility: Washington University School of Medicine

location_facility: Pretoria Academic Hospital, Department of Radiation Oncology

location_facility: Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance

location_facility: Erie County Medical Center (Roswell Park)

location_facility: Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie

location_facility: Cliniques Universitaires UCL Mont Godinne, Service Hématologie

location_facility: Szpital Wojewódzki w Opolu/Oddział Hematologii

location_facility: Klinik Essen Süd, Evangelisches Krankenhaus

location_facility: Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences

location_facility: H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241

location_facility: Clinique Universitaire Saint Luc, Service Hématologie

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

location_facility: The Royal Marsden Haemato-Oncology Wards

location_facility: Münchner Studienzentrum Klinikum Rechts der Isar

location_facility: Yale Cancer Center-Section of Medical Oncology

location_facility: Belgyógyászati Klinika es Kardiologial Központ

location_facility: University of Liege, Divisions of Hematology and Medical Oncology

location_facility: Instytut Hematologii i Transfuzjologii Klinika Hematologii

location_facility: Rambam Medical Center Department of Hematology

location_facility: Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala

location_facility: Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry

location_facility: Groupe Hospitalier Sud Réunion, Site Saint-Pierre

location_facility: Leitender Oberarzt/Klinik für Onkologie und Hämatologie

location_facility: The UT Health Science Centre at San Antonio

location_facility: VU Medical Center, Department of Haematology

location_facility: Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland

location_facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii

location_facility: Klinika Hematologie a Onkohematologie FNLP a LF UPJS

location_facility: Tygerberg Hospital, Department of Radiation Oncology

location_facility: Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica

location_facility: Universitätsmedizin der johannes Gutenberg -Universität Mainz

location_facility: St James's Institute of Oncology Bexley Wing

location_facility: Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)

location_facility: Isala Clinics, Department of Haematololgy

location_facility: Northern Centre for Cancer Care, Freeman Hospital

location_facility: Universität Göttingen, Abteilung Hämatologie und Onkologie

location_facility: Hospital Clinico Universitario de Santiago

location_facility: University Medical Center Groningen UMCG, Department of Haematologie

location_facility: Hadassah University Hospital Sharet Building Department of Hematology

location_facility: University of Tennessee Cancer Institute

location_facility: State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: The Christie NHS Foundation Trust, The Christie Hospital,

summary: The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.


title: Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

summary: An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology. This is for individuals for whom antibiotic therapy has failed, but of consideration in all cases, taking into account antibiotic-induced adverse reactions and increasing antibiotic resistance.

status: Available

study_type: Expanded Access

ReferenceCitation: Benito-Villalvilla C, Cirauqui C, Diez-Rivero CM, Casanovas M, Subiza JL, Palomares O. MV140, a sublingual polyvalent bacterial preparation to treat recurrent urinary tract infections, licenses human dendritic cells for generating Th1, Th17, and IL-10 responses via Syk and MyD88. Mucosal Immunol. 2017 Jul;10(4):924-935. doi: 10.1038/mi.2016.112. Epub 2016 Dec 14.

ReferenceCitation: Yang B, Foley S. First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune(®). BJU Int. 2018 Feb;121(2):289-292. doi: 10.1111/bju.14067. Epub 2017 Nov 23.

ReferenceCitation: Lorenzo-Gómez MF, Padilla-Fernández B, García-Cenador MB, Virseda-Rodríguez ÁJ, Martín-García I, Sánchez-Escudero A, Vicente-Arroyo MJ, Mirón-Canelo JA. Comparison of sublingual therapeutic vaccine with antibiotics for the prophylaxis of recurrent urinary tract infections. Front Cell Infect Microbiol. 2015 Jun 3;5:50. doi: 10.3389/fcimb.2015.00050. eCollection 2015.

ReferenceCitation: Ramírez Sevilla C, Gómez Lanza E, Manzanera JL, Martín JAR, Sanz MÁB. Active immunoprophyilaxis with uromune® decreases the recurrence of urinary tract infections at three and six months after treatment without relevant secondary effects. BMC Infect Dis. 2019 Oct 28;19(1):901. doi: 10.1186/s12879-019-4541-y.

lead_sponsor: Impatients N.V. trading as myTomorrows

location_country: Denmark Romania Luxembourg Serbia Slovenia Netherlands Finland Sweden France Turkey Belgium Norway Germany Slovakia Czechia

location_facility:
Denmark
Romania
Luxembourg
Serbia
Slovenia
Finland
Czech Republic
The Netherlands
Sweden
France
Turkey
Belgium
Norway
Germany
Slovakia


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)

summary: Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).

lead_sponsor: Teva Pharmaceutical Industries, Ltd.

location_country:
United Kingdom
Italy
France
Israel
Belgium
Germany

location_facility:
Teva Benelux
Teva UK
Teva France
Teva Israel
Teva Germany
Teva Italy


title: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts

acronym: PLATFORM

summary: The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.

ReferenceCitation: Hlatky MA, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas PS; PLATFORM Investigators. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-2323. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct 14.

lead_sponsor: HeartFlow, Inc.

location_country:
Denmark
United Kingdom
Italy
Austria
United States
France
Belgium
Germany

location_facility: Deutsches Herzzentrum München - ISAResearch Centre

location_facility: Freeman Hospital - Therapeutics & Cardiac Research Team

location_facility: Duke University Clinical Research Institution

location_facility: Innsbruck Medical University, Department of Radiology II

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France

location_facility: LKH-GRAZ-West - Department of Cardiology


acronym: DELOS

title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy

lead_sponsor: Santhera Pharmaceuticals

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

ReferenceCitation: Meier T, Rummey C, Leinonen M, Spagnolo P, Mayer OH, Buyse GM; DELOS Study Group. Characterization of pulmonary function in 10-18 year old patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2017 Apr;27(4):307-314. doi: 10.1016/j.nmd.2016.12.014. Epub 2017 Jan 6.

location_country:
Spain
Italy
Austria
Netherlands
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Azienda Ospedaliera Niguarda Ca' Granda Centro Clinico Nemo

location_facility: University of California Davis Medical Center

location_facility: Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Carolinas Medical Center, Neurosciences and Spine Institute

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliera Universitaria della Seconda Università degli Studi di Napoli

location_facility: Universitätsklinikum Essen, Zentrum für Kinderheikunde

location_facility: Monroe Carell, Jr. Children's Hospital at Vanderbilt

location_facility: University Hospitals Leuven- Children Hospital

summary: The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.


title: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis

summary: This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).

lead_sponsor: Novartis Pharmaceuticals

location_country:
United Kingdom
Italy
Netherlands
Canada
Switzerland
United States
France
Belgium
Germany

location_facility:
Novartis USA
Novartis France
Novartis Italy
Novartis Germany
Novartis Netherlands
Novartis Belgium
Novartis CANADA
Novartis UK
Novartis Switzerland


title: Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer

summary: The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance.

status: Unknown status

primary_purpose: Other

lead_sponsor: Centre Oscar Lambret

location_facility: Unité d'Oncologie et d'hématologie ONCOSUD

location_facility: Centre Pierre Curie - SCP de radiologie et d'imagerie médicale

location_facility: Le Confluent - Centre Catherine de Sienne


title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.

summary: The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).

ReferenceCitation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.

ReferenceCitation: Rennard SI, Calverley PM, Goehring UM, Bredenbröker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12:18. doi: 10.1186/1465-9921-12-18.

lead_sponsor: AstraZeneca

location_country:
Poland
Portugal
Spain
Italy
Austria
Australia
Russian Federation
Canada
United Kingdom
Switzerland
Hungary
France
South Africa
Netherlands


type: Registry Identifier

title: Réseau Structurant Sur le Cancer de la Prostate du Grand Ouest

acronym: RESCAP

summary:
The project aims at developing and structuring a network of clinicians, pathologists, and scientists, from the "Grand Ouest" area, most of them already involved in prostate cancer management and research.

Patients treated by radical prostatectomy will be recruited within the ReSCaP network of clinicians, with centralized database and standardized bio-resource collection, including prostate and adipose tissue samples. Seven clinical centers will participate to the network, 6 recruiting mainly Caucasian patients, and 1 from the French West Indies recruiting mainly African Caribbean patients. After 18 months, 1000 patients will be included.

The main goal is to study the relationships between adipose tissue/lipids and prostate cancer aggressiveness. In fact, adipose tissue is likely to be involved in cancer progression at many levels: abdominal obesity has been associated with aggressive disease, and poly-unsaturated fatty acids (PUFAs), as well as cytokines produced by adipocytes (adipokines) have an impact on cancer cells growth and migration in vitro. Moreover, adipose tissue is the preferential site of storage of persistent organic pollutants with estrogenic properties, which could impact cancer progression.

The study will analyze the association between adipose tissue (distant from the prostate) composition and cancer aggressiveness. Among the 1000 patients, 100 aggressive tumors will be selected according to the d'Amico criteria (Gleason score 8 or more and/or pT3 tumors). They will be matched with 100 potentially indolent prostate cancers (Gleason 6 or less, and PSA less than 10, and pT2 stage on the surgical specimen). These 200 adipose tissue samples will be analyzed for 1/ the lipid profile, including the fatty acid composition, particularly PUFAs, that reflects past dietary fat intake, 2/ adipokine expression, and 3/ tissue concentrations of persistent organic pollutants belonging to the class of organochlorine pesticides with hormone-like activity.

lead_sponsor: University Hospital, Tours

location_country: France Guadeloupe

location_facility:
Urology CHRU-TOURS
Uniersity Hospital
University Hospital

lead_sponsor_type: academique


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

summary: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.

ReferenceCitation: Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.

ReferenceCitation: Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.

ReferenceCitation: McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.

ReferenceCitation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3). doi: 10.4088/PCC.14m01741. eCollection 2015.

ReferenceCitation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

ReferenceCitation: Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Croatia
Poland
Latvia
Estonia
Finland
Lithuania
France
South Africa
Romania
Slovakia


title: Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)

acronym: POLAR

summary: This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.

primary_purpose: Diagnostic

lead_sponsor: Lille Catholic University

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Régional Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Univetrsitaire de Rouen

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Intercommunal Poissy-St-Germain

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand


title: Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis

acronym: LARMES

summary: In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Centre hospitalier universitaire (CHU), Nice

location_facility: Centre hospitalier régional universitaire

location_facility: Centre hospitalier régional universtaire

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)


acronym: Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in mCRPC (KEYNOTE-365)

title: Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Yu EY, Kolinsky MP, Berry WR, Retz M, Mourey L, Piulats JM, Appleman LJ, Romano E, Gravis G, Gurney H, Bogemann M, Emmenegger U, Joshua AM, Linch M, Sridhar S, Conter HJ, Laguerre B, Massard C, Li XT, Schloss C, Poehlein CH, de Bono JS. Pembrolizumab Plus Docetaxel and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort B Study. Eur Urol. 2022 Jul;82(1):22-30. doi: 10.1016/j.eururo.2022.02.023. Epub 2022 Apr 6.

location_country:
Denmark
Poland
Taiwan
United Kingdom
Ireland
Austria
Italy
Netherlands
Canada
New Zealand
Russian Federation
Ukraine
Sweden
United States
France
Turkey
Mexico
Germany

location_facility: Call for Information (Investigational Site 2038)

location_facility: Call for Information (Investigational Site 2041)

location_facility: Call for Information (Investigational Site 0015)

location_facility: Call for Information (Investigational Site 0016)

location_facility: Call for Information (Investigational Site 2027)

location_facility: Call for Information (Investigational Site 2080)

location_facility: Call for Information (Investigational Site 2065)

location_facility: Call for Information (Investigational Site 2086)

location_facility: Call for Information (Investigational Site 2018)

location_facility: Call for Information (Investigational Site 0008)

location_facility: Call for Information (Investigational Site 2084)

location_facility: Call for Information (Investigational Site 0005)

location_facility: Call for Information (Investigational Site 2089)

location_facility: Call for Information (Investigational Site 0010)

location_facility: Call for Information (Investigational Site 0007)

location_facility: Call for Information (Investigational Site 2090)

location_facility: Call for Information (Investigational Site 2091)

location_facility: Call for Information (Investigational Site 2002)

summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be nine cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, and Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2. Outcome measures will be assessed individually for each cohort.


title: A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)

ReferenceCitation: Marabelle A, Le DT, Ascierto PA, Di Giacomo AM, De Jesus-Acosta A, Delord JP, Geva R, Gottfried M, Penel N, Hansen AR, Piha-Paul SA, Doi T, Gao B, Chung HC, Lopez-Martin J, Bang YJ, Frommer RS, Shah M, Ghori R, Joe AK, Pruitt SK, Diaz LA Jr. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2020 Jan 1;38(1):1-10. doi: 10.1200/JCO.19.02105. Epub 2019 Nov 4.

ReferenceCitation: O'Malley DM, Bariani GM, Cassier PA, Marabelle A, Hansen AR, De Jesus Acosta A, Miller WH Jr, Safra T, Italiano A, Mileshkin L, Amonkar M, Yao L, Jin F, Norwood K, Maio M. Health-related quality of life with pembrolizumab monotherapy in patients with previously treated advanced microsatellite instability high/mismatch repair deficient endometrial cancer in the KEYNOTE-158 study. Gynecol Oncol. 2022 Aug;166(2):245-253. doi: 10.1016/j.ygyno.2022.06.005. Epub 2022 Jul 11.

ReferenceCitation: Even C, Delord JP, Price KA, Nakagawa K, Oh DY, Burge M, Chung HC, Doi T, Fakih M, Takahashi S, Yao L, Jin F, Norwood K, Hansen AR. Evaluation of pembrolizumab monotherapy in patients with previously treated advanced salivary gland carcinoma in the phase 2 KEYNOTE-158 study. Eur J Cancer. 2022 Aug;171:259-268. doi: 10.1016/j.ejca.2022.05.007. Epub 2022 Jun 28.

ReferenceCitation: Maio M, Ascierto PA, Manzyuk L, Motola-Kuba D, Penel N, Cassier PA, Bariani GM, De Jesus Acosta A, Doi T, Longo F, Miller WH, Oh DY, Gottfried M, Xu L, Jin F, Norwood K, Marabelle A. Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. Ann Oncol. 2022 Sep;33(9):929-938. doi: 10.1016/j.annonc.2022.05.519. Epub 2022 Jun 6.

ReferenceCitation: Maio M, Amonkar MM, Norquist JM, Ascierto PA, Manzyuk L, Motola-Kuba D, Penel N, Cassier PA, Bariani GM, De Jesus Acosta A, Doi T, Longo F, Miller WH Jr, Oh DY, Gottfried M, Wang R, Norwood K, Marabelle A. Health-related quality of life in patients treated with pembrolizumab for microsatellite instability-high/mismatch repair-deficient advanced solid tumours: Results from the KEYNOTE-158 study. Eur J Cancer. 2022 Jul;169:188-197. doi: 10.1016/j.ejca.2022.03.040. Epub 2022 May 16.

ReferenceCitation: Shapira-Frommer R, Mileshkin L, Manzyuk L, Penel N, Burge M, Piha-Paul SA, Girda E, Lopez Martin JA, van Dongen MGJ, Italiano A, Xu L, Jin F, Norwood K, Ott PA. Efficacy and safety of pembrolizumab for patients with previously treated advanced vulvar squamous cell carcinoma: Results from the phase 2 KEYNOTE-158 study. Gynecol Oncol. 2022 Aug;166(2):211-218. doi: 10.1016/j.ygyno.2022.01.029. Epub 2022 Mar 28.

ReferenceCitation: Marabelle A, Cassier PA, Fakih M, Kao S, Nielsen D, Italiano A, Guren TK, van Dongen MGJ, Spencer K, Bariani GM, Ascierto PA, Santoro A, Shah M, Asselah J, Iqbal S, Takahashi S, Piha-Paul SA, Ott PA, Chatterjee A, Jin F, Norwood K, Delord JP. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4. Epub 2022 Feb 1.

ReferenceCitation: O'Malley DM, Bariani GM, Cassier PA, Marabelle A, Hansen AR, De Jesus Acosta A, Miller WH Jr, Safra T, Italiano A, Mileshkin L, Xu L, Jin F, Norwood K, Maio M. Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study. J Clin Oncol. 2022 Mar 1;40(7):752-761. doi: 10.1200/JCO.21.01874. Epub 2022 Jan 6.

ReferenceCitation: Yap TA, Nakagawa K, Fujimoto N, Kuribayashi K, Guren TK, Calabrò L, Shapira-Frommer R, Gao B, Kao S, Matos I, Planchard D, Chatterjee A, Jin F, Norwood K, Kindler HL. Efficacy and safety of pembrolizumab in patients with advanced mesothelioma in the open-label, single-arm, phase 2 KEYNOTE-158 study. Lancet Respir Med. 2021 Jun;9(6):613-621. doi: 10.1016/S2213-2600(20)30515-4. Epub 2021 Apr 6.

ReferenceCitation: Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K, Chung HC, Kindler HL, Lopez-Martin JA, Miller WH Jr, Italiano A, Kao S, Piha-Paul SA, Delord JP, McWilliams RR, Fabrizio DA, Aurora-Garg D, Xu L, Jin F, Norwood K, Bang YJ. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol. 2020 Oct;21(10):1353-1365. doi: 10.1016/S1470-2045(20)30445-9. Epub 2020 Sep 10.

ReferenceCitation: Piha-Paul SA, Oh DY, Ueno M, Malka D, Chung HC, Nagrial A, Kelley RK, Ros W, Italiano A, Nakagawa K, Rugo HS, de Braud F, Varga AI, Hansen A, Wang H, Krishnan S, Norwood KG, Doi T. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies. Int J Cancer. 2020 Oct 15;147(8):2190-2198. doi: 10.1002/ijc.33013. Epub 2020 May 2.

ReferenceCitation: Strosberg J, Mizuno N, Doi T, Grande E, Delord JP, Shapira-Frommer R, Bergsland E, Shah M, Fakih M, Takahashi S, Piha-Paul SA, O'Neil B, Thomas S, Lolkema MP, Chen M, Ibrahim N, Norwood K, Hadoux J. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Neuroendocrine Tumors: Results From the Phase II KEYNOTE-158 Study. Clin Cancer Res. 2020 May 1;26(9):2124-2130. doi: 10.1158/1078-0432.CCR-19-3014. Epub 2020 Jan 24.

ReferenceCitation: Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.

location_country:
Denmark
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
Mexico
Canada
Netherlands
Philippines
Korea, Republic of
United States
France
China
Israel
Colombia
Norway
Germany
South Africa

location_facility: Call for Information (Investigational Site 0202)

location_facility: Call for Information (Investigational Site 0017)

summary: In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).


acronym: A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphoma

title: A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

ReferenceCitation: Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.

location_country:
Brazil
United Kingdom
Italy
Australia
Sweden
Korea, Republic of
United States
France
Israel
Germany

location_facility: Call for Information (Investigational Site 0025)

location_facility: Call for Information (Investigational Site 0056)

location_facility: Call for Information (Investigational Site 0026)

location_facility: Call for Information (Investigational Site 0019)

location_facility: Call for Information (Investigational Site 0069)

location_facility: Call for Information (Investigational Site 0054)

location_facility: Call for Information (Investigational Site 0014)

location_facility: Call for Information (Investigational Site 0031)

location_facility: Call for Information (Investigational Site 0012)

summary:
This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer:

advanced melanoma (6 months to <18 years of age),
advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age),
relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or
advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or
advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age)

Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D.

The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts.

With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid tumors also continues.


title: European Dyspnoea Survey in the EMergency Departments

acronym: EuroDEM

summary:
Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms patients can experience; and it is one of the main complaints in the patients presenting to the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac, pulmonary or metabolic etiologies or a combination of them, since several diseases can cause dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary disease (COPD).

Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure (HF) is one of the most important causes of morbidity and mortality in the industrialized world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general European population. The incidence increases rapidly with age, and in Europe. Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to hospital have been adequately described, in Europe and in the United States. The Euro Heart Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively.

This same sensation of breathlessness is what also drives patients with asthma and chronic obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD) exacerbation accounts for approximately 1.5 million ED visits in the United States per year. It is the third most common cause of hospitalization, with an estimated 726 000 hospitalizations in 2000 in the USA. Previous studies have demonstrated important differences between guideline recommendations and actual management of COPD exacerbation, either in the ED or during hospitalization.

The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low sensitivity of the clinical signs associated with the aging of the population and the variety of underlying diseases. Little is known about the Epidemiology of dyspneic patients in the ED at the European level. Diagnosis, prevalence and treatment of the patients may vary among European countries.

lead_sponsor: Hopital Lariboisière

location_country:
Romania
Spain
Italy
United Kingdom
Netherlands
Finland
France
Turkey
Belgium
Germany

location_facility:
Country: Netherlands
Country: United Kingdom
Country: Belgium
Country: Finland
Country: Turkey
Country: France
Country: Italy
Country: Germany
Country: Spain
Country: Romania


acronym: PLEO-CMT

title: International, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study Assessing in Parallel Groups the Efficacy and Safety of 2 Doses of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A Treated 15 Months

lead_sponsor: Pharnext SA

ReferenceCitation: Attarian S, Vallat JM, Magy L, Funalot B, Gonnaud PM, Lacour A, Péréon Y, Dubourg O, Pouget J, Micallef J, Franques J, Lefebvre MN, Ghorab K, Al-Moussawi M, Tiffreau V, Preudhomme M, Magot A, Leclair-Visonneau L, Stojkovic T, Bossi L, Lehert P, Gilbert W, Bertrand V, Mandel J, Milet A, Hajj R, Boudiaf L, Scart-Grès C, Nabirotchkin S, Guedj M, Chumakov I, Cohen D. An exploratory randomised double-blind and placebo-controlled phase 2 study of a combination of baclofen, naltrexone and sorbitol (PXT3003) in patients with Charcot-Marie-Tooth disease type 1A. Orphanet J Rare Dis. 2014 Dec 18;9:199. doi: 10.1186/s13023-014-0199-0. Erratum in: Orphanet J Rare Dis. 2016;11(1):92.

ReferenceCitation: Chumakov I, Milet A, Cholet N, Primas G, Boucard A, Pereira Y, Graudens E, Mandel J, Laffaire J, Foucquier J, Glibert F, Bertrand V, Nave KA, Sereda MW, Vial E, Guedj M, Hajj R, Nabirotchkin S, Cohen D. Polytherapy with a combination of three repurposed drugs (PXT3003) down-regulates Pmp22 over-expression and improves myelination, axonal and functional parameters in models of CMT1A neuropathy. Orphanet J Rare Dis. 2014 Dec 10;9:201. doi: 10.1186/s13023-014-0201-x.

ReferenceCitation: Mandel J, Bertrand V, Lehert P, Attarian S, Magy L, Micallef J, Chumakov I, Scart-Grès C, Guedj M, Cohen D. A meta-analysis of randomized double-blind clinical trials in CMT1A to assess the change from baseline in CMTNS and ONLS scales after one year of treatment. Orphanet J Rare Dis. 2015 Jun 13;10:74. doi: 10.1186/s13023-015-0293-y.

ReferenceCitation: Prukop T, Stenzel J, Wernick S, Kungl T, Mroczek M, Adam J, Ewers D, Nabirotchkin S, Nave KA, Hajj R, Cohen D, Sereda MW. Early short-term PXT3003 combinational therapy delays disease onset in a transgenic rat model of Charcot-Marie-Tooth disease 1A (CMT1A). PLoS One. 2019 Jan 16;14(1):e0209752. doi: 10.1371/journal.pone.0209752. eCollection 2019.

ReferenceCitation: Hajj R, Prukop T, Wernick S, Ewers D, Brureau A, Cholet N, Laffaire J, Nave KA, Cohen D, Sereda M. Baclofen, Naltrexone and Sorbitol all contribute to the efficacy of PXT3003 in CMT1A Rats. EMJ Neurol, 2019;7[1]:47-49

ReferenceCitation: Attarian S, Vallat JM, Magy L, Funalot B, Gonnaud PM, Lacour A, Péréon Y, Dubourg O, Pouget J, Micallef J, Franques J, Lefebvre MN, Ghorab K, Al-Moussawi M, Tiffreau V, Preudhomme M, Magot A, Leclair-Visonneau L, Stojkovic T, Bossi L, Lehert P, Gilbert W, Bertrand V, Mandel J, Milet A, Hajj R, Boudiaf L, Scart-Grès C, Nabirotchkin S, Guedj M, Chumakov I, Cohen D. Erratum to: An exploratory randomised double-blind and placebo-controlled phase 2 study of a combination of baclofen, naltrexone and sorbitol (PXT3003) in patients with Charcot-Marie-Tooth disease type 1A. Orphanet J Rare Dis. 2016 Jul 7;11(1):92.

location_country:
Spain
United Kingdom
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Centre de Référence des Maladies Neuromusculaires, Hôpital Swynghedauwl, CHU de Lille

location_facility: Centre de Référence des Maladies Neuromusculaires, Pôle des Neurosciences Clinique, CHU la Timone

location_facility: Department for Sleep Medicine and Neuromuscular, University Hospital Münster

location_facility: Servicio de Neurologia, Hospital Universitario La Paz

location_facility: Centre de Référence des Maladies Neuromusculaires; Hôtel Dieu, CHU de Nantes

location_facility: Service de Neurologie, Hôpital Kremlin Bicêtre

location_facility: Department of Neurology, University of Minnesota

location_facility: Department of Neurology, McKnight Brain Institute

location_facility: Department of Neurology, Salford Royal NHS Foundation Trust

location_facility: Centro de Diagnostico y Tratamiento, Hospital Universitario Virgen del Rocio

location_facility: Department of Neurology, Ludwig-Maximillian University, Munich

location_facility: Service de Neurologie et du Sommeil, CHU Lyon Sud

location_facility: Departement of Neurology, Academic Medical Center

location_facility: Department of neurology, Hospital Univesitario de Bellvitge

location_facility: Servicio de Neurologia, Hospital Univesitari i Politécnic La Fe

location_facility: Department of Neurology and Psichiatry, Saint Louis University

location_facility: Centre de Référence des Neuropathies Périphériques Rares, Hôpital Dupuytren, CHU Limoges

location_facility: Peripheral Neuropathy Center, Neurological Institue Building, Columbia University Medical Center

location_facility: Department of Neurology and Institute for Neuropathology, University Hospital RWTH Aachen

location_facility: Department of Clinical Neurophysiology, University Medical Center Göttingen

location_facility: Department of Neurology, Cedars-Sinai Medical Center

summary: The purpose of this study is to determine whether PXT3003 is effective and safe in the treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated for 15 months.


title: Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis (TOACT)

acronym: TOACT

summary:
Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis despite treatment with heparin. Published experience with ET is promising, but only based on case series and not on controlled trials.

Objective: The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT

Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial.

Study population: Patients are eligible if they have a radiologically proven CVT, a high probability of poor outcome (defined by presence of one or more of the following risk factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system) and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better.

Intervention: Patients will be randomized to receive either ET or standard therapy (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale and relevant laboratory parameters will be assessed at baseline.

Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most important secondary outcomes are the mRS, mortality and recanalization rate at 6 months. Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome. Results will be analyzed according to the "intention-to-treat" principle. Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient.

Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in each treatment arm) have to be included (two-sided alpha, 80% power).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from ET. Complications of ET, most notably intracranial hemorrhages, constitute the most important risk of the study.

ReferenceCitation: Coutinho JM, Stam J. How to treat cerebral venous and sinus thrombosis. J Thromb Haemost. 2010 May;8(5):877-83. doi: 10.1111/j.1538-7836.2010.03799.x. Epub 2010 Feb 9. Review.

ReferenceCitation: Canhão P, Falcão F, Ferro JM. Thrombolytics for cerebral sinus thrombosis: a systematic review. Cerebrovasc Dis. 2003;15(3):159-66. Review.

ReferenceCitation: Ciccone A, Canhão P, Falcão F, Ferro JM, Sterzi R. Thrombolysis for cerebral vein and dural sinus thrombosis. Cochrane Database Syst Rev. 2004;(1):CD003693. Review.

ReferenceCitation: Stam J, Majoie CB, van Delden OM, van Lienden KP, Reekers JA. Endovascular thrombectomy and thrombolysis for severe cerebral sinus thrombosis: a prospective study. Stroke. 2008 May;39(5):1487-90. doi: 10.1161/STROKEAHA.107.502658. Epub 2008 Mar 13.

ReferenceCitation: Coutinho JM, Zuurbier SM, Bousser MG, Ji X, Canhão P, Roos YB, Crassard I, Nunes AP, Uyttenboogaart M, Chen J, Emmer BJ, Roosendaal SD, Houdart E, Reekers JA, van den Berg R, de Haan RJ, Majoie CB, Ferro JM, Stam J; TO-ACT investigators. Effect of Endovascular Treatment With Medical Management vs Standard Care on Severe Cerebral Venous Thrombosis: The TO-ACT Randomized Clinical Trial. JAMA Neurol. 2020 Aug 1;77(8):966-973. doi: 10.1001/jamaneurol.2020.1022.

ReferenceCitation: Coutinho JM, Ferro JM, Zuurbier SM, Mink MS, Canhão P, Crassard I, Majoie CB, Reekers JA, Houdart E, de Haan RJ, Bousser MG, Stam J. Thrombolysis or anticoagulation for cerebral venous thrombosis: rationale and design of the TO-ACT trial. Int J Stroke. 2013 Feb;8(2):135-40. doi: 10.1111/j.1747-4949.2011.00753.x. Epub 2012 Feb 20.

lead_sponsor: Jan Stam, MD, PhD

location_country: Portugal Canada Switzerland France China Netherlands

location_facility: Centre hospitalier de l'université de Montréal (CHUM)


title: A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma

summary:
Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.

The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

ReferenceCitation: Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbröker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22.

ReferenceCitation: Meltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbröker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
South Africa
Philippines
Poland
Portugal
Austria
Russian Federation
India
Norway
Singapore
Hungary
Taiwan
Greece
Ireland
New Zealand
Finland
Czech Republic
Thailand
France
Pakistan


title: MOnitoring REsynchronization deviCes and cARdiac patiEnts

acronym: MORE-CARE

summary:
The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices

Remote monitoring with CareLink Network System
Standard management of the disease by means of scheduled routine in-patient follow-ups;

and to demonstrate that the remote monitoring strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

ReferenceCitation: Burri H, Quesada A, Ricci RP, Boriani G, Davinelli M, Favale S, Da Costa A, Kautzner J, Moser R, Navarro X, Santini M. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. Am Heart J. 2010 Jul;160(1):42-8. doi: 10.1016/j.ahj.2010.04.005.

ReferenceCitation: Boriani G, Da Costa A, Ricci RP, Quesada A, Favale S, Iacopino S, Romeo F, Risi A, Mangoni di S Stefano L, Navarro X, Biffi M, Santini M, Burri H; MORE-CARE Investigators. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring. J Med Internet Res. 2013 Aug 21;15(8):e167. doi: 10.2196/jmir.2608.

ReferenceCitation: Burri H, da Costa A, Quesada A, Ricci RP, Favale S, Clementy N, Boscolo G, Villalobos FS, Mangoni di S Stefano L, Sharma V, Boriani G; MORE-CARE Investigators. Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator. Europace. 2018 May 1;20(5):e69-e77. doi: 10.1093/europace/eux206.

ReferenceCitation: Boriani G, Da Costa A, Quesada A, Ricci RP, Favale S, Boscolo G, Clementy N, Amori V, Mangoni di S Stefano L, Burri H; MORE-CARE Study Investigators. Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial. Eur J Heart Fail. 2017 Mar;19(3):416-425. doi: 10.1002/ejhf.626. Epub 2016 Aug 28.

lead_sponsor: Medtronic Bakken Research Center

location_country:
Spain
Greece
Italy
Czech Republic
Switzerland
Hungary
France
Israel
Netherlands
Slovakia

location_facility: Gottsegen György Országos Kardiológia Intézet GOKI

location_facility: Centre Hospitalier Universitaire de Angers

location_facility: Ospedale Civile Maggiore di Borgo Trento

location_facility: Azienda Ospedaliera Sacro Cuore Don Calabria

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Policlinico Universitario S. Orsola-Malpighi

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

intervention_type: Device


title: A 24-week, Double Blind, Randomized Study to Investigate the Effect of 500 µg Roflumilast Tablets Once Daily Versus Placebo on Parameters Indicative of Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease

summary: The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.

location_country:
Poland
Spain
United Kingdom
Canada
United States
France
South Africa


title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.

summary: The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

ReferenceCitation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.

ReferenceCitation: Rennard SI, Calverley PM, Goehring UM, Bredenbröker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12:18. doi: 10.1186/1465-9921-12-18.

location_country:
Poland
Canada
United States
France
South Africa
Germany


title: A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.

location_country:
Poland
Brazil
Italy
Hungary
France
United States
India
South Africa
Belgium
Turkey
Sweden

location_facility:
Sites in Belgium
Sites in France
Sites in Turkey
Sites in Hungary
Sites in India
Sites in Sweden
Sites in Brazil
sites in Italy
Sites in Poland
Sites in USA
Sites in South Africa

summary: The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).


title: A Double-Blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.

summary: To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.

ReferenceCitation: Gallo G, Brock F, Kerkmann U, Kola B, Huizinga TW. Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage. RMD Open. 2016 Apr 21;2(1):e000186. doi: 10.1136/rmdopen-2015-000186. eCollection 2016.

ReferenceCitation: van der Heijde D, Klareskog L, Landewé R, Bruyn GA, Cantagrel A, Durez P, Herrero-Beaumont G, Molad Y, Codreanu C, Valentini G, Zahora R, Pedersen R, MacPeek D, Wajdula J, Fatenejad S. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007 Dec;56(12):3928-39.

location_country:
Denmark
Poland
Portugal
Romania
Spain
Greece
Austria
Australia
Italy
Finland
Czech Republic
Netherlands
United Kingdom
Sweden
France
Israel
Belgium
Norway
Germany


title: A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

summary: The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

ReferenceCitation: Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.

ReferenceCitation: Braun J, Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. J Rheumatol. 2012 Apr;39(4):836-40. doi: 10.3899/jrheum.110885. Epub 2012 Feb 15.

ReferenceCitation: Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Arthritis Rheum. 2011 Jun;63(6):1543-51. doi: 10.1002/art.30223.

location_country:
Denmark
Poland
Saudi Arabia
Ireland
Austria
Australia
Italy
Finland
Czech Republic
Netherlands
Qatar
Spain
Hungary
Sweden
France
China
United Kingdom
Germany


type: U.S. NIH Grant/Contract

title: Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea Therapy in the Treatment of High Risk Polycythemia Vera (PV) and High Risk Essential Thrombocythemia (ET)

summary:
This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increases the risk of developing blood clots.

The purpose of this study is to look at the effectiveness of giving participants who have been diagnosed with ET or PV one of two different study regimens over time. The study subject will be followed for their condition for about 5 years. The subject will be randomized into one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or Aspirin and Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed or already receiving treatment for either PV or ET. Each of the study drugs used in this study is already being used to treat subjects with ET or PV currently, but the investigators are unsure which study drug is better.

ReferenceCitation: Mascarenhas J, Kosiorek HE, Prchal JT, Rambaldi A, Berenzon D, Yacoub A, Harrison CN, McMullin MF, Vannucchi AM, Ewing J, O'Connell CL, Kiladjian JJ, Mead AJ, Winton EF, Leibowitz DS, De Stefano V, Arcasoy MO, Kessler CM, Catchatourian R, Rondelli D, Silver RT, Bacigalupo A, Nagler A, Kremyanskaya M, Levine MF, Arango Ossa JE, McGovern E, Sandy L, Salama ME, Najfeld V, Tripodi J, Farnoud N, Penson AV, Weinberg RS, Price L, Goldberg JD, Barbui T, Marchioli R, Tognoni G, Rampal RK, Mesa RA, Dueck AC, Hoffman R. A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia. Blood. 2022 May 12;139(19):2931-2941. doi: 10.1182/blood.2021012743.

ReferenceCitation: Yacoub A, Mascarenhas J, Kosiorek H, Prchal JT, Berenzon D, Baer MR, Ritchie E, Silver RT, Kessler C, Winton E, Finazzi MC, Rambaldi A, Vannucchi AM, Leibowitz D, Rondelli D, Arcasoy MO, Catchatourian R, Vadakara J, Rosti V, Hexner E, Kremyanskaya M, Sandy L, Tripodi J, Najfeld V, Farnoud N, Papaemmanuil E, Salama M, Singer-Weinberg R, Rampal R, Goldberg JD, Barbui T, Mesa R, Dueck AC, Hoffman R. Pegylated interferon alfa-2a for polycythemia vera or essential thrombocythemia resistant or intolerant to hydroxyurea. Blood. 2019 Oct 31;134(18):1498-1509. doi: 10.1182/blood.2019000428.

lead_sponsor: Ronald Hoffman

location_country:
United States
Italy
United Kingdom
France

location_facility: Wake Forest University Baptist Medical Center

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


title: A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

summary:
This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer.

This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect.

Patients who sign up for this trial must also fall into one of these categories:

Patients have already received treatment with platinum-containing chemotherapy
Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

ReferenceCitation: McGregor B, O'Donnell PH, Balar A, Petrylak D, Rosenberg J, Yu EY, Quinn DI, Heath EI, Campbell M, Hepp Z, McKay C, Steinberg J, Regnault A, Mazerolle F, Galsky MD. Health-related Quality of Life of Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin after Platinum and PD-1/PD-L1 Inhibitor Therapy: Results from Cohort 1 of the Phase 2 EV-201 Clinical Trial. Eur Urol. 2022 May;81(5):515-522. doi: 10.1016/j.eururo.2022.01.032. Epub 2022 Feb 12.

ReferenceCitation: Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, Stein MN, Necchi A, Kojima T, Harrison MR, Hoon Park S, Quinn DI, Heath EI, Rosenberg JE, Steinberg J, Liang SY, Trowbridge J, Campbell M, McGregor B, Balar AV. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):872-882. doi: 10.1016/S1470-2045(21)00094-2. Epub 2021 May 12. Erratum in: Lancet Oncol. 2021 Jun;22(6):e239.

ReferenceCitation: Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, Hahn NM, Gartner EM, Pinelli JM, Liang SY, Melhem-Bertrandt A, Petrylak DP. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600. doi: 10.1200/JCO.19.01140. Epub 2019 Jul 29.

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Inc

location_country:
Spain
Italy
Netherlands
Korea, Republic of
United States
France
Japan
Germany

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: New York University (NYU) Cancer Institute

location_facility: University of California Irvine - Newport

location_facility: James P. Wilmot Cancer Center / University of Rochester Medical Center

location_facility: Keck Medical Center / University of Southern California

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: James Cancer Hospital / Ohio State University

location_facility: Kaiser Permanente Medical Center Northern California

location_facility: Chao Family Comprehensive Cancer Center University of California Irvine

location_facility: University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center


title: Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) - A Randomised Clinical Trial

summary: ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.

ReferenceCitation: Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Åneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Køber L, Langørgen J, Lilja G, Møller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33°C versus 36°C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.

ReferenceCitation: Robba C, Badenes R, Battaglini D, Ball L, Sanfilippo F, Brunetti I, Jakobsen JC, Lilja G, Friberg H, Wendel-Garcia PD, Young PJ, Eastwood G, Chew MS, Unden J, Thomas M, Joannidis M, Nichol A, Lundin A, Hollenberg J, Hammond N, Saxena M, Martin A, Solar M, Taccone FS, Dankiewicz J, Nielsen N, Grejs AM, Ebner F, Pelosi P; TTM2 Trial collaborators. Oxygen targets and 6-month outcome after out of hospital cardiac arrest: a pre-planned sub-analysis of the targeted hypothermia versus targeted normothermia after Out-of-Hospital Cardiac Arrest (TTM2) trial. Crit Care. 2022 Oct 21;26(1):323. doi: 10.1186/s13054-022-04186-8.

ReferenceCitation: Lang M, Leithner C, Scheel M, Kenda M, Cronberg T, During J, Rylander C, Annborn M, Dankiewicz J, Deye N, Halliday T, Lascarrou JB, Matthew T, McGuigan P, Morgan M, Thomas M, Ullén S, Undén J, Nielsen N, Moseby-Knappe M. Prognostic accuracy of head computed tomography for prediction of functional outcome after out-of-hospital cardiac arrest: Rationale and design of the prospective TTM2-CT-substudy. Resusc Plus. 2022 Oct 12;12:100316. doi: 10.1016/j.resplu.2022.100316. eCollection 2022 Dec.

ReferenceCitation: Düring J, Annborn M, Cariou A, Chew MS, Dankiewicz J, Friberg H, Haenggi M, Haxhija Z, Jakobsen JC, Langeland H, Taccone FS, Thomas M, Ullén S, Wise MP, Nielsen N. Influence of temperature management at 33 °C versus normothermia on survival in patients with vasopressor support after out-of-hospital cardiac arrest: a post hoc analysis of the TTM-2 trial. Crit Care. 2022 Jul 31;26(1):231. doi: 10.1186/s13054-022-04107-9.

ReferenceCitation: Robba C, Badenes R, Battaglini D, Ball L, Brunetti I, Jakobsen JC, Lilja G, Friberg H, Wendel-Garcia PD, Young PJ, Eastwood G, Chew MS, Unden J, Thomas M, Joannidis M, Nichol A, Lundin A, Hollenberg J, Hammond N, Saxena M, Annborn M, Solar M, Taccone FS, Dankiewicz J, Nielsen N, Pelosi P; TTM2 Trial Collaborators. Ventilatory settings in the initial 72 h and their association with outcome in out-of-hospital cardiac arrest patients: a preplanned secondary analysis of the targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest (TTM2) trial. Intensive Care Med. 2022 Aug;48(8):1024-1038. doi: 10.1007/s00134-022-06756-4. Epub 2022 Jul 2.

ReferenceCitation: Robba C, Nielsen N, Dankiewicz J, Badenes R, Battaglini D, Ball L, Brunetti I, Pedro David WG, Young P, Eastwood G, Chew MS, Jakobsen J, Unden J, Thomas M, Joannidis M, Nichol A, Lundin A, Hollenberg J, Lilja G, Hammond NE, Saxena M, Martin A, Solar M, Taccone FS, Friberg HA, Pelosi P. Ventilation management and outcomes in out-of-hospital cardiac arrest: a protocol for a preplanned secondary analysis of the TTM2 trial. BMJ Open. 2022 Mar 3;12(3):e058001. doi: 10.1136/bmjopen-2021-058001.

ReferenceCitation: Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullén S, Rylander C, Wise MP, Oddo M, Cariou A, Bělohlávek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, Düring J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otáhal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Undén J, Brunetti I, Awad A, McGuigan P, Bjørkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.

ReferenceCitation: Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Bělohlávek J, Callaway C, Cariou A, Eastwood G, Erlinge D, Hovdenes J, Joannidis M, Kirkegaard H, Kuiper M, Levin H, Morgan MPG, Nichol AD, Nordberg P, Oddo M, Pelosi P, Rylander C, Saxena M, Storm C, Taccone F, Ullén S, Wise MP, Young P, Friberg H, Nielsen N. Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): A randomized clinical trial-Rationale and design. Am Heart J. 2019 Nov;217:23-31. doi: 10.1016/j.ahj.2019.06.012. Epub 2019 Jun 26.

lead_sponsor: Helsingborgs Hospital

location_country:
Denmark
United Kingdom
Italy
Austria
Australia
New Zealand
Switzerland
Sweden
United States
France
Belgium
Norway
Germany
Czechia

location_facility: Basildon and Thurrock Hospitals NHS Foundation Trust - Essex CTC

location_facility: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust


title: A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection

summary: This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

ReferenceCitation: Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.

location_country:
Denmark
Taiwan
Hong Kong
Portugal
Saudi Arabia
Greece
Italy
Australia
Spain
Finland
United Kingdom
Switzerland
France
India
China
Turkey
South Africa
Philippines
Germany


title: A Phase 1/2 Study of REGN7257 (Anti-Interleukin 2 Receptor Subunit Gamma [IL2RG] Monoclonal Antibody) in Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy

lead_sponsor: Regeneron Pharmaceuticals

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

location_country:
Korea, Republic of
United States
United Kingdom
France

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

summary:
The primary objective of this study is to assess the safety and tolerability of REGN7257 in patients with immunosuppressive therapy (IST)-refractory or IST-relapsed severe aplastic anemia (SAA). An additional primary objective (for Part B only) is to evaluate the clinical efficacy of REGN7257 in patients with IST-refractory or IST-relapsed SAA.

The secondary objectives of this study are to assess the following for REGN7257:

Clinical response over time
Maintenance of response
Impact on transfusion requirements
Effect on blood counts and cell populations
Pharmacokinetics (PK)
Immunogenicity


title: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Clopidogrel Plus Acetylsalicylic Acid (ASA) Versus ASA Alone in Subjects With Acute ST Elevation Myocardial Infarction (STEMI) Treated With Fibrinolytic Therapy

summary: The purpose of this study is to determine if the combination of aspirin plus clopidogrel is more effective than aspirin alone in preventing another heart attack, chest pain, stroke or death in people who have already had a heart attack that was treated with fibrinolytic therapy.

ReferenceCitation: Sabatine MS, Cannon CP, Gibson CM, López-Sendón JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. Epub 2005 Mar 9.

ReferenceCitation: Harkness JR, Sabatine MS, Braunwald E, Morrow DA, Sloan S, Wiviott SD, Giugliano RP, Antman EM, Cannon CP, Scirica BM. Extent of ST-segment resolution after fibrinolysis adds improved risk stratification to clinical risk score for ST-segment elevation myocardial infarction. Am Heart J. 2010 Jan;159(1):55-62. doi: 10.1016/j.ahj.2009.10.033.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Ireland
France
Netherlands

location_facility:
sanofi-aventis Netherlands
Sanofi-Aventis Hungaria
sanofi-aventis South Africa
Sanofi-Aventis
sanofi-aventis Brazil
sanofi-aventis Canada
sanofi-aventis Austria
sanofi-aventis Poland
sanofi-aventis Spain
sanofi-aventis Belgium
sanofi-aventis Sweden
sanofi-aventis UK
sanofi-aventis France
sanofi-aventis Italy
Sanofi-Aventis Mexico
sanofi-aventis Germany