type: Registry Identifier

title: A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

summary: The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

ReferenceCitation: Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug 4. pii: S1542-3565(22)00718-2. doi: 10.1016/j.cgh.2022.07.027. [Epub ahead of print]

ReferenceCitation: Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.

ReferenceCitation: Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Törüner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Takeda

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Slovakia
Bosnia and Herzegovina
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Latvia
Estonia
Korea, Republic of
France
Colombia
Netherlands

location_facility: SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: University of North Carolina at Chapel Hill

location_facility: Gastroenterology Consultants of South Texas, PA

location_facility: Centro Hospitalar e Universitario de Coimbra E.P.E

location_facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Pauls Stradins Clinical University Hospital SLLC

location_facility: Morales Vargas Centro de Investigacion, S.C.

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Fundacion Oftalmologica de Santander - FOSCAL

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Center for Digestive Health and Nutritional Excellence

location_facility: SBEI HPE "Rostov State Medical University" of the MoH of the RF

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

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

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

location_facility: Long Island Clinical Research Associates

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont

location_facility: Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: SBIH of Yaroslavl region " Regional Clinical Hospital "

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

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

location_facility: Klaipeda University Hospital, Public Institution

location_facility: Gastroenterology Associates of Tidewater

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: Medical University of South Carolina (MUSC)

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

location_facility: FSBI State Scientific Centre of Coloproctology" of the MoH of RF

location_facility: Expertia S.A- Mautalen Salud e Investigacion

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oost

location_facility: FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Texas Digestive Disease Consultants - Irving

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

location_facility: Klaipeda Republican Hospital, Public Institution

location_facility: Groupe Hospitalier Sud - Hopital Haut-Leveque

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: CI A.and O. Tropiny City Clinical Hospital

location_facility: McMaster University Health Sciences Center

location_facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF

location_facility: The Oregon Clinic-West Hills Gastroenterology

location_facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Centro de Investigacion Farmacologica del Bajio, S.C.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: California Medical Research Associates Inc.

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution

location_facility: Alegent Creighton Clinic Gastroenterology

location_facility: SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

location_facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: SPb SBIH "City Hospital of Saint Martyr Elizaveta"

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Seoul National University Bundang Hospital

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Seconda Universita degli Studi di Napoli

location_facility: Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE

location_facility: SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU

location_facility: RSBIH "Smolensk Regional Clinical Hospital"

location_facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

location_facility: Ohio State University Clinical Trials Management Office

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Gastroenterology Research of San Antonio, LLC

location_facility: Clinical Hospital Center "Sestre Milosrdnice"

location_facility: SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital


ipd_sharing: Undecided

status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Drug

title: Intergroup Trial UNICANCER UC 0105-1305/ IFCT 1301: SAFIR02_Lung - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Non-small Cell Lung Cancer

study_completion_date_type: Anticipated

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Middleton G, Crack LR, Popat S, Swanton C, Hollingsworth SJ, Buller R, Walker I, Carr TH, Wherton D, Billingham LJ. The National Lung Matrix Trial: translating the biology of stratification in advanced non-small-cell lung cancer. Ann Oncol. 2015 Dec;26(12):2464-9. doi: 10.1093/annonc/mdv394. Epub 2015 Sep 25.

enrollment_type: Actual

location_facility: Hospices Civils de Lyon- Hôpital Louis Pradel

location_facility: Centre Hospitalier Universitaire de Besancon - Hopital Jean Minjoz

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Montpied

location_facility: Centre Hopsitalier Intercommunal de Créteil

summary: Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in Autosomal Dominant Polycystic Kidney Disease (ADPKD): The GeneQuest Study

acronym: GeneQuest

summary:
The aim of this study is to identify families with ADPKD , characterize the phenotype and screen for mutations in known genes (PKD1 and PKD2, and then HNF1b and UMOD in PKD1 PKD2 negative carriers).

Genome wide analysis will be performed in families without mutations identified.

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

ReferenceCitation: Lefèvre S, Audrézet MP, Halimi JM, Longuet H, Bridoux F, Ecotière L, Augusto JF, Duveau A, Renaudineau E, Vigneau C, Frouget T, Charasse C, Gueguen L, Perrichot R, Couvrat G, Seret G, Le Meur Y, Cornec-Le Gall E; Genkyst Study Group. Diagnosis and risk factors for intracranial aneurysms in autosomal polycystic kidney disease: a cross-sectional study from the Genkyst cohort. Nephrol Dial Transplant. 2022 Oct 19;37(11):2223-2233. doi: 10.1093/ndt/gfac027.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Centre de néphrologie et de dialyse d'Armorique

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

lead_sponsor: Shire

ReferenceType: result

ReferenceCitation: Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15.

ReferenceCitation: Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25.

ReferenceCitation: Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5.

ReferenceCitation: Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20.

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Sweden
Hungary
France
Belgium
Germany

location_facility: Complejo Hospitalario Universitario de Badajoz

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,

location_facility: Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185

location_facility: Lighthouse Child Development Centre, Snakes Lane

location_facility: Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10

location_facility: Hôpital Gui de Chauliac, 80, avenue Augustin Fliche

location_facility: Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5

location_facility: Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4

location_facility: Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12

location_facility: Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

location_facility: Università degli Studi di Cagliari, Dipartimento di Neuroscienze

location_facility: Ryegate Children's Centre, Tapton Crescent Road

location_facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital

location_facility: Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003

location_facility: Victoria Hospital, Paediatric Unit, Hayfield Road

location_facility: Azienda Ospedaliera della 2 Universita di Napoli

location_facility: Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent

location_facility: ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken

location_facility: Hospital Universitario de Canarias C/Ofra

location_facility: Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10

location_facility: Hospital Ramón y Cajal, Servicio de psiquiatría

location_facility: Tayside Childrens Hospital, Clinical Research Facility, Level 4

location_facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego

location_facility: Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Praxis für Neuropädiatrie, Schomburgstrasse 120

location_facility: Basildon Hospital, Child Developement Centre, Nethermayne

location_facility: Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó

location_facility: Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie

location_facility: Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica

location_facility: Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.


title: A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era. Survey of Pharmacological and Virological Resistance of Cytomegalovirus to Antiviral Therapy in Transplantation.

acronym: ORPHAVIC

summary:
Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5% of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol studies. This prevalence vary with the organ transplanted and the degree of viral replication and immunosuppression. Less data are available to date from real-life cohorts of patients, and there is no systematic survey of resistance in Europe or in the US. Non response to treatment concerns a larger group of patients and can result either from emergence of a resistant strain (virological resistance), from inadequate dosage of antivirals, or a high degree of immunosuppression, with a poor CMV immune response. The respective clinical impact of virological resistance and clinical resistance (of pharmacological or immunological origin) on graft outcome and long-term survival of patients has never been assessed. High viral loads and persistent replication associated to prolonged exposure to antivirals are known to favor the emergence of resistant strains. Though epidemiology of resistant strains, role of multiple infections, impact of various mutations on degree of resistance to antivirals and outcome remains to be further studied. Most studies are per-protocol studies or short-term studies conducted on limited populations. There are no data in real-life of transplanted patients at the era of enlarged prophylaxis except those from the French survey for cytomegalovirus resistance cohort opened at the end of 2006. From the first data collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer outcome in case of virological resistance and to the absence of impact of prophylaxis versus preemptive therapy, though larger populations and prolonged follow-up are requested to fulfill all objectives.

We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large number of patients and a prolonged follow-up, to gather data on resistance to antivirals in real-life of transplant patients in an organized data bank, This cohort is in the continuum of our previous cohort started in 2006, granted by the Hospital Clinical Research Program Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Limoges

location_facility: AP-HP - Hôpital Saint-Antoine - Virologie

location_facility: AP-HP - Hôpital Georges Pompidou - Virologie

location_facility: HCLYON - Virologie - Hôpital La Croix Rousse

location_facility: Virologie - Hôpital La Pitié Salpétrière

intervention_type: Biological


title: A Phase 1 First in Human, Multicenter, Open-Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and RP2D of ABBV-184 in Subjects With Previously Treated Cancers

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. This study focuses on two types of cancers: Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer (NSCLC). AML (blood cancer) is cancer of the white blood cells (WBC). NSCLC (solid tumor) is a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine recommended phase 2 dose (RP2D) and to see if the study drug is safe and able to treat patients who have AML and NSCLC.

ABBV-184 is an investigational drug being developed for treatment of cancer. The study has two arms and two phases: AML arm and NSCLC arm; dose escalation and dose expansion phase. Adult participants with diagnosis of AML or NSCLC will be enrolled. In dose escalation phase, around 36 participants will be enrolled in each arm. In dose expansion phase, around 20 participants will be enrolled in each arm. The study will be conducted in approximately 50 sites across 10 countries.

Participants will receive weight based intravenous (IV) infusion of ABBV-184 once a week. At the beginning of the study, visits will occur daily during hospitalization followed by less frequently over time.

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

status: Terminated

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: AbbVie

location_country:
United Kingdom
United States
Israel
France
Japan

location_facility: Gabrail Cancer Center Research /ID# 215667

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 215703

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 217508

location_facility: National Cancer Center Hospital East /ID# 216467

location_facility: Centre Antoine Lacassagne - Nice /ID# 218014

location_facility: Cardiff & Vale University Health Board /ID# 217250

location_facility: Fort Wayne Medical Oncology and Hematology, Inc /ID# 224332

location_facility: Aichi Cancer Center Hospital /ID# 216469

location_facility: Tel Aviv Sourasky Medical Center /ID# 222749

location_facility: National Cancer Center Hospital /ID# 216466

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 217252

location_facility: The Chaim Sheba Medical Center /ID# 215810

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 224998

status_simplified: Unknown


type: Other Identifier

title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

status: Recruiting

enrollment_type: Anticipated

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:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Norway
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Holston Valley Hospital and Medical Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli

location_facility: CHUM - Centre Hospitalier de l'Université de Montréal

location_facility: Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)

location_facility: Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet

location_facility: Sahyadri Clinical Research & Development Centre

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: The Second Hospital of Tianjin Medical University

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")

location_facility: MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia

location_facility: Private Medical Institution "Euromedservice"

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

location_facility: Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Sandton Oncology Medical Group (Pty) Ltd

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD

location_facility: Clinical Research Unit, University of Pretoria

location_facility: SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan

location_facility: Centre of Applied Urology Research, Nova Scotia Health Authority

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

location_facility: BHI of Omsk region "Clinical Oncological Dispensary"

location_facility: West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica

location_facility: Harbin Medical University Cancer Hospital

location_facility: Rajiv Gandhi Cancer Institute and Research Centre

location_facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi

location_facility: Fondazione Casa Sollievo della Sofferenza

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Providence Cancer Institute Franz Clinic

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: Gallipoli Medical Research Foundation, Greenslopes Private Hospital

location_facility: Providence Oncology and Hematology Care Clinic - Westside

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Federal State Budgetary Institution "Central Clinical Hospital with ambulance"

location_facility: Providence Cancer Institute Newberg Clinic

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Adana City Training and Research Hospital

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Istanbul University, Cerrahpasa Faculty of Medicine

location_facility: Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)

location_facility: University Health Network-Princess Margaret Cancer Centre

location_facility: Branch of the Limited Liability Company "Hadassah Medical Ltd."

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Hamamatsu University School of Medicine University Hospital

location_facility: Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"

location_facility: The Third Xiangya Hospital of Central South University

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

location_facility: Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)

location_facility: SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: AdventHealth Medical Group Hematology and Oncology

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Texas Oncology-Deke Slayton Cancer Center

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD

location_facility: Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of

location_facility: Institut fuer Diagnostische und Interventionelle Radiologie

location_facility: Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of

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

location_facility: Bhakti Vedanta Hospital and Research Institute

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Netaji Subhas Chandra Bose Cancer Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department

location_facility: Complex Oncology Center - Stara Zagora Ltd.

location_facility: West China Hospital of Sichuan University

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Communal Non-Profit Enterprise "Regional Center of Oncology"

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")

location_facility: National Hospital Organization Tokyo Medical Center

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

location_facility: Centro de Investigacion Pergamino SA - Clinica Pergamino SA

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

location_facility: Independent medical-diagnostic laboratory "Medisken" EOOD

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Centro de Investigaciones Clínicas - Clínica Viedma

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Instituto Veracruzano en Investigación Clínica S.C.

location_facility: IRCCS Istituto Tumori "Giovanni Paolo II" di Bari

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte

location_facility: Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"

location_facility: Hospital Universitario Central de Asturias

location_facility: Mid-Illinois Hematology & Oncology Associates, Ltd

location_facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

location_facility: AZ (Algemeen Ziekenhuis) Maria Middelares

location_facility: Huntsman Cancer Institute - University of Utah

location_facility: Investigational Drug Services, Advent Health Orlando

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntr

location_facility: Providence Cancer Institute Clackamas Clinic


title: Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution

acronym: PHRC-TVC

summary:
Cerebral venous thrombosis is considered as a rare type of stroke with an annual incidence of 3 to 4 per million people. It occurs generally in young patients (mean age of occurrence = 40 years) and principally in young females (75%) generally in pregnancy or oral contraceptive use situations.

The onset may be acute (less than 2 days), subacute (between 2 and 30 days) or chronic (more than 30 days). The clinical presentation is highly variable and includes patients with only a mild headache, others with focal neurological deficits and a few with a dramatic syndrome and a coma. Moreover the evolution can be very different with unpredictable outcome: more often it is favorable with a low mortality rate, but in some cases it can be a worse course. The aim of this study is to evaluate the correlation of some biological markers: thrombin generation test and D-Dimers (marker of fibrin generation and degradation) with the type of onset or the wide spectrum of clinical presentations or the different modes of evolution.

All patients over 16 years ago may be included in the program when CVT diagnosis is proved by magnetic resonance angiography (MRA). For each included patient, there are four blood assays: the first just at the time of diagnosis and before the beginning of treatment, the second before the beginning of the oral anticoagulant treatment. The third assay is done in the third month at the time of a MRA. The last assay is made one month after the end of the anticoagulant treatment or in 12th month after the beginning of the disease if the treatment goes on.

For each sample, the investigators perform a thrombin generation test and a D-Dimers measurement.

ReferenceCitation: Triquenot Bagan A, Crassard I, Drouet L, Barbieux-Guillot M, Marlu R, Robinet-Borgomino E, Morange PE, Wolff V, Grunebaum L, Klapczynski F, André-Kerneis E, Pico F, Martin-Bastenaire B, Ellie E, Menard F, Rouanet F, Freyburger G, Godenèche G, Allano HA, Moulin T, Mourey G, Derex L, Berruyer M, Runavot G, Trichet C, Viader F, Le Querrec A, Husein TT, Cluet-Dennetiere S, Macian-Montoro F, Donnard M, Guillon B, Ternisien C, Zuber M, Laplanche S, Tassan P, Peeltier JY, Canaple S, Roussel B, Gaillard N, Scavazza E, Le Cam Duchez V. Cerebral Venous Thrombosis: Clinical, Radiological, Biological, and Etiological Characteristics of a French Prospective Cohort (FPCCVT)-Comparison With ISCVT Cohort. Front Neurol. 2021 Nov 8;12:753110. doi: 10.3389/fneur.2021.753110. eCollection 2021.

lead_sponsor: University Hospital, Rouen

location_facility:
Chu D' Angers
Hôpital de la Timone
C.H. Yves Le Foll
Hôpital Côte de Nacre
C.H. de Versailles
C.H.U de Strasbourg
C.H. de Perpignan - Hôpital Saint-Jean
Hôpitaux Civils de Colmar
Hôpital Jean Minjioz
Chu Amiens
C.H.U. de Grenoble
G.H.U. Carémeau
Hôpital Neurologique de Lyon
GH Pitié-Salpêtrière
CHU hopitaux de rouen
C.H.U. Limoges
C.H.U de Poitiers
Hôpital de la Cavale Blanche
CHRU Bretonneau
CH Côte Basque
CHU-Hôpital Général
C.H. de La Rochelle
C.H. François Quesnay
CHU Estaing
C.H. de Meaux
Hôpital J. Monod
C.H.I. Eure-Seine
C.H. de Compiègne
Hôpital Nord de Laënnec
C.H. Saint-Denis
Ch Victor Dupouy
Hôpital Pellegrin - CHU Bordeaux
Hôpital Guy de Chauliac
Hôpital Henri Mondor
G.H. Paris Saint-Joseph
CHI de Poissy- site de Poissy


title: Description of Sign-and-symptom Associations at Acromegaly Diagnosis.

acronym: ACRO-POLIS

summary: The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.

time_perspective: Retrospective

ReferenceCitation: Caron P, Brue T, Raverot G, Tabarin A, Cailleux A, Delemer B, Renoult PP, Houchard A, Elaraki F, Chanson P. Signs and symptoms of acromegaly at diagnosis: the physician's and the patient's perspectives in the ACRO-POLIS study. Endocrine. 2019 Jan;63(1):120-129. doi: 10.1007/s12020-018-1764-4. Epub 2018 Sep 29. Erratum in: Endocrine. 2018 Oct 31;:.

lead_sponsor: Ipsen

location_facility: Chu de Grenoble Hôpital Albert Michallon


title: Impact of Drug Reconciliation at Discharge and Pharmaceutical Communication Between Hospital and Community Pharmacists on Drug Related Problems: Study Protocol for a Cluster Randomized Cross-over Trial

acronym: REPHVIM

summary: This study will evaluate the impact of a communication between hospital pharmacist and community pharmacists in addition to drugs reconciliation procedure at discharge. It will be conducted in 21 french public hospitals.

status: Unknown status

ReferenceCitation: Pourrat X, Roux C, Bouzige B, Garnier V, Develay A, Allenet B, Fraysse M, Halimi JM, Grassin J, Giraudeau B. Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial. Trials. 2014 Jun 30;15:260. doi: 10.1186/1745-6215-15-260.

lead_sponsor: University Hospital, Tours

location_facility:
Hopital Inter Armées
Centre Hospitalier
Centre Hospitalier Alès-Cévennes
Centre Hospitalier Pierre Bérégovoy
Hopital ESTAING
Hopital de Mercy Metz-Thionville
Centre Hospitalier Compiègne-Noyon
Hopital de la Cavale Blanche
Hopital Jacques Monod
CHU Conception
Hopital Archet
Hopital de Hautepierre
Hopitaux civils de Colmar
Centre Hospitalier Universitaire


title: A Randomized Study Comparing the Incidence of Acute Clinical or Subclinical Rejection With Two Dosing Regimens of CellCept in de Novo Renal Transplant Recipients Receiving Induction, Cyclosporine and Brief Steroid Therapy

summary: This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.

lead_sponsor: Hoffmann-La Roche


title: A Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy

acronym: TOSCA

summary: This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic drugs (csDMARDs) in participants with moderate to severe active rheumatoid arthritis who have an inadequate response or are intolerant to non-biologic csDMARDs and/or biologic therapy.

ReferenceCitation: Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Pethö-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

ReferenceCitation: Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Pethö-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443. Erratum in: Rheumatology (Oxford). 2018 Jun 1;57(6):1129.


title: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

acronym: CURASMUR

summary: All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation.

ReferenceCitation: Guihard B, Chollet-Xémard C, Lakhnati P, Vivien B, Broche C, Savary D, Ricard-Hibon A, Marianne Dit Cassou PJ, Adnet F, Wiel E, Deutsch J, Tissier C, Loeb T, Bounes V, Rousseau E, Jabre P, Huiart L, Ferdynus C, Combes X. Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial. JAMA. 2019 Dec 17;322(23):2303-2312. doi: 10.1001/jama.2019.18254.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
CH Annecy
CHU Henri Mondor
CHU de la Réunion
CHU Avicenne
CHU Lariboisière
CHU de Dijon
CH Gonesse
CHU de La Réunion
CHU de Nîmes
CHU Raymond Poincaré
CHU Pitié-Salpêtrière
CHU Toulouse - Hôpital PURPAN
CH René Dubos
CHRU de Lille
CHU Necker
CHU Hôtel-Dieu
CH Marc Jacquet


title: Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.

acronym: REPERE

summary:
The main objective is to assess the role of antenatal detection of fetal growth restriction (FGR) on stillbirth, by a case-control study in a population-based sample of small for gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of French customised birth weight curves.

Our secondary objectives are

to identify determinants of antenatal detection of FGR among a representative sample of SGA births, with a special interest in the definition of FGR. Our hypothesis is that births who are SGA by customised birthweight curves and non-SGA by population birthweight curves, are not detected antenatally, despite the current strategy including the use of umbilical Doppler.
to analyse prenatal care of a subsample of SGA stillbirths with and without detection of FGR by a confidential enquiry.

ReferenceType: background

ReferenceCitation: Altman DG, Hytten FE. Intrauterine growth retardation: let's be clear about it. Br J Obstet Gynaecol. 1989 Oct;96(10):1127-32.

ReferenceCitation: Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. Review.

ReferenceCitation: Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.

ReferenceCitation: Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. Review.

ReferenceCitation: Hecher K, Snijders R, Campbell S, Nicolaides K. Fetal venous, intracardiac, and arterial blood flow measurements in intrauterine growth retardation: relationship with fetal blood gases. Am J Obstet Gynecol. 1995 Jul;173(1):10-5.

ReferenceCitation: Severi FM, Bocchi C, Visentin A, Falco P, Cobellis L, Florio P, Zagonari S, Pilu G. Uterine and fetal cerebral Doppler predict the outcome of third-trimester small-for-gestational age fetuses with normal umbilical artery Doppler. Ultrasound Obstet Gynecol. 2002 Mar;19(3):225-8.

ReferenceCitation: Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009 May 7;9 Suppl 1:S5. doi: 10.1186/1471-2393-9-S1-S5. Review.

ReferenceCitation: Imdad A, Yakoob MY, Siddiqui S, Bhutta ZA. Screening and triage of intrauterine growth restriction (IUGR) in general population and high risk pregnancies: a systematic review with a focus on reduction of IUGR related stillbirths. BMC Public Health. 2011 Apr 13;11 Suppl 3:S1. doi: 10.1186/1471-2458-11-S3-S1. Review.

ReferenceCitation: Alfirevic Z, Neilson JP. Doppler ultrasonography in high-risk pregnancies: systematic review with meta-analysis. Am J Obstet Gynecol. 1995 May;172(5):1379-87.

ReferenceCitation: Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. Review. Update in: Cochrane Database Syst Rev. 2007;(2):CD001451. Cochrane Database Syst Rev. 2008;(4):CD001451.

ReferenceCitation: Bricker L, Neilson JP, Dowswell T. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001451. doi: 10.1002/14651858.CD001451.pub3. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD001451.

ReferenceCitation: Neilson JP, Alfirevic Z. Doppler ultrasound for fetal assessment in high risk pregnancies. Cochrane Database Syst Rev. 2000;(2):CD000073. Review. Update in: Cochrane Database Syst Rev. 2010;(1):CD000073.

ReferenceCitation: GRIT Study Group. A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. BJOG. 2003 Jan;110(1):27-32.

ReferenceCitation: Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20.

ReferenceCitation: Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Effectiveness of detection of intrauterine growth retardation by abdominal palpation as screening test in a low risk population: an observational study. Eur J Obstet Gynecol Reprod Biol. 2004 Oct 15;116(2):164-9.

ReferenceCitation: Jahn A, Razum O, Berle P. Routine screening for intrauterine growth retardation in Germany: low sensitivity and questionable benefit for diagnosed cases. Acta Obstet Gynecol Scand. 1998 Jul;77(6):643-8.

ReferenceCitation: Mattioli KP, Sanderson M, Chauhan SP. Inadequate identification of small-for-gestational-age fetuses at an urban teaching hospital. Int J Gynaecol Obstet. 2010 May;109(2):140-3. doi: 10.1016/j.ijgo.2009.11.023. Epub 2010 Feb 2.

ReferenceCitation: Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64.

ReferenceCitation: Ogundipe EM, Wolfe CD, Seed P, Gamsu HR. Does the antenatal detection of small-for-gestational-age babies influence their two-year outcomes? Am J Perinatol. 2000;17(2):73-81.

ReferenceCitation: Fretts RC, Boyd ME, Usher RH, Usher HA. The changing pattern of fetal death, 1961-1988. Obstet Gynecol. 1992 Jan;79(1):35-9.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinique Saint Vincent de Paul Bourgoin Jallieu


title: Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study

acronym: HYPERION

summary:
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

ReferenceCitation: Ziriat I, Le Thuaut A, Colin G, Merdji H, Grillet G, Girardie P, Souweine B, Dequin PF, Boulain T, Frat JP, Asfar P, Francois B, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Massart N, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Reignier J, Cariou A, Lascarrou JB. Outcomes of mild-to-moderate postresuscitation shock after non-shockable cardiac arrest and association with temperature management: a post hoc analysis of HYPERION trial data. Ann Intensive Care. 2022 Oct 17;12(1):96. doi: 10.1186/s13613-022-01071-z.

ReferenceCitation: Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.

ReferenceCitation: Lascarrou JB, Meziani F, Le Gouge A, Boulain T, Bousser J, Belliard G, Asfar P, Frat JP, Dequin PF, Gouello JP, Delahaye A, Hssain AA, Chakarian JC, Pichon N, Desachy A, Bellec F, Thevenin D, Quenot JP, Sirodot M, Labadie F, Plantefeve G, Vivier D, Girardie P, Giraudeau B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group and HYPERION Study Group. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. Scand J Trauma Resusc Emerg Med. 2015 Mar 7;23:26. doi: 10.1186/s13049-015-0103-5.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_country: France Guadeloupe

location_facility:
CHU Pointe à Pitre
Cochin University Hospital Center
Medical Surgical Intensive Care Unit
Medical Intensive Care Unit

intervention_type: Procedure


intervention_type: Radiation

title: A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

location_facility: Groupe Oncorad Garonne Clinique Du Pont de Chaume

location_facility: Centre d'oncologie et de radiothérapie du Parc

location_facility: Hôpital d'Instruction des Armées du Val de Grâce

location_facility: Institut de Cancérologie de l'Ouest -Site Paul Papin

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

location_facility: Institut de Cancérologie LUCIEN NEUWIRTH

location_facility: GUSTAVE ROUSSY, Cancer Campus, Grand Paris

summary: The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.


title: A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

summary: This Registry will enroll participants with cirrhosis with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

ReferenceCitation: Younossi ZM, Racila A, Muir A, Bourliere M, Mangia A, Esteban R, Zeuzem S, Colombo M, Manns M, Papatheodoridis GV, Buti M, Chokkalingam A, Gaggar A, Nader F, Younossi I, Henry L, Stepanova M. Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response. Clin Gastroenterol Hepatol. 2022 Feb;20(2):438-446. doi: 10.1016/j.cgh.2021.01.026. Epub 2021 Jan 22.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

lead_sponsor: Gilead Sciences

location_country:
Spain
Italy
United Kingdom
Australia
New Zealand
Canada
Puerto Rico
United States
France
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: University of California, Davis Medical Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Gastroenterology Center of the MidSouth, P.C.

location_facility: Community Research Initiative of New England

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Bon Secours St. Mary's Hospital of Richmond

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Nashville Gastrointestinal Specialists, Inc.

location_facility: London Health Sciences Centre - University Campus

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: University of California at San Francisco Medical Center

location_facility: University of Pennsylvania Health System

location_facility: Asheville Gastroenterology Associates, PA

location_facility: University of Miami Miller School of Medicine

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: The North Texas Clinical Research Institute

location_facility: South Florida Center of Gastroenterology

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Binghamton Gastroenterology Associates, PC


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

ReferenceCitation: Bourlière M, Bronowicki JP, de Ledinghen V, Hézode C, Zoulim F, Mathurin P, Tran A, Larrey DG, Ratziu V, Alric L, Hyland RH, Jiang D, Doehle B, Pang PS, Symonds WT, Subramanian GM, McHutchison JG, Marcellin P, Habersetzer F, Guyader D, Grangé JD, Loustaud-Ratti V, Serfaty L, Metivier S, Leroy V, Abergel A, Pol S. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015 Apr;15(4):397-404. doi: 10.1016/S1473-3099(15)70050-2. Epub 2015 Mar 13. Erratum in: Lancet Infect Dis. 2015 Jul;15(7):761.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

summary:
This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.

Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks

Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks

Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA < the lower limit of quantitation (LLOQ), or achieved HCV RNA < LLOQ).


title: A Non-Inferiority, Multicentered, Controlled, Randomized, Double Blinded Study Investigating the Antibiotic Treatment Duration (3-day Versus 8-day) for Subjects Admitted to Emergency Services With Acute Non-severe Community Acquired Pneumonia (CAP)

acronym: PTC

summary: To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).

ReferenceCitation: Dinh A, Ropers J, Duran C, Davido B, Deconinck L, Matt M, Senard O, Lagrange A, Makhloufi S, Mellon G, de Lastours V, Bouchand F, Mathieu E, Kahn JE, Rouveix E, Grenet J, Dumoulin J, Chinet T, Pépin M, Delcey V, Diamantis S, Benhamou D, Vitrat V, Dombret MC, Renaud B, Perronne C, Claessens YE, Labarère J, Bedos JP, Aegerter P, Crémieux AC; Pneumonia Short Treatment (PTC) Study Group. Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial. Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5. Erratum in: Lancet. 2021 Jun 5;397(10290):2150.

lead_sponsor: Versailles Hospital

location_facility:
CH Beaujon
CHU Rennes Pontchaillou
Foch Hospital
CH Versailles
CHU Rouen
CH Lariboisière
CHU Saint Antoine
CH Argenteuil
CHU de Grenoble
CH d'Annecy Genevois
CHU Ambroise Paré
CH Bicêtre
CHU Cochin
CHU Bichat
CH Tenon
CH Pontoise
CH Saint Denis
Central Hospital Raymon Poincaré
CHI Creteil
Melun Hospital


title: Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment

acronym: PREVACT

summary:
The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding.

Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K.

However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad.

The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy.

PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.

lead_sponsor: University Hospital, Angers

location_facility:
CH Agen
Chg Montauban
CHU Angers
Ch Les Sables D'Olonne
Ch Longjumeau
CHG du Mans
CHU Pitié Salpétrière
Ch Annecy
Chu Nantes
Chu Saint Brieuc
CHU Nice
Ch Saint Malo
CHU Clermont Ferrand
CHU METZ
HCL Edouard Herriot
Ch Versailles
Chu Toulouse
CHU Chateauroux
Chu Poitiers
Chu Tenon
Chu Tours


title: Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer - A Prospective Observational Study in Elderly Patients With Non-small Cells Lung Cancer

acronym: OPERAGE

summary: schema : Prospective prognostic study The main objective is to study the value of the Comprehensive Geriatric Assessment in predicting the risk of post operative complications after lung resection for cancer.

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 19
Hospital Saint Antoine
Site 42
Site 32
Centre François Baclesse
Centre Hospitalier Universitaire
Site 12
Site 14
Centre Hospitalier Les Oudairies
Site 20
Centre Hospitalier du Morvan
Site 11
Site 41
Site 04
Hôpital Yves Le Foll
Site 06
Centre Hospitalier René Dubos
Site 18
Site 33
Site 17
Centre Hospitalier D Argenteuil
Site 07
Hospital du Cluzeau
Centre Hospitalier Régional
Site 30


acronym: SERODIFF

summary:
Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection.

This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal control without Clostridium difficile, and non-diarrheal control with or without Clostridium difficile). Recurrence and the kinetics of immune response following infection Clostridium difficile are studied by following the patients during three months.

There are also building biological samples collections clinically documented: sera, stool and strains.

primary_purpose: Prevention

location_facility: Groupe Hospitalier Sainte-Périne / Rossini / Chardon Lagache

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

summary: The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, Ports WC, Tan H, Tallman A, Valdez H, Gardner AC. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018 Oct;179(4):853-862. doi: 10.1111/bjd.16798. Epub 2018 Aug 13.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

location_country:
Croatia
Serbia
Spain
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Mexico
Singapore
Sweden
Slovakia
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: University of North Carolina at Chapel Hill

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat

location_facility: Deaconess Clinic Downtown Research Institute

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

location_facility: Dept of Dermatology and Venerology of ONMU

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: North Florida Dermatology Associates, PA

location_facility: Nemocnice Ceske Budejovice, a.s. Ustavni lekarna

location_facility: Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski

location_facility: Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny

location_facility: Regional Municipal Dermatovenerologic Dispensary

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"

location_facility: UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia

location_facility: Hopital de Brabois / Batiment Philippe Canton

location_facility: Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika

location_facility: Tsentar za kozhno venericheski zaboliavania EOOD

location_facility: University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease

location_facility: Ryazan regional clinical dermatovenerologic dispensary

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: CHU Limoges - Hôpital Dupuytren - Pharmacie

location_facility: Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,

location_facility: Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

location_facility: Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika

location_facility: Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu

location_facility: Chang Gung Medical Foundation Kaohsiung Branch

location_facility: Novum Instytut Dermatologii Leczniczej i Estetycznej

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: State Research Center of Dermatovenerology

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: CRCMRGilbert Inc., Centre de Dermatologie Maizerets

location_facility: Tampere Univeristy Hospital, Department of Dermatology and Venereology

location_facility: Dr. Tuppal's Privat Practice, Oshawa Clinic

location_facility: Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: IP ONLY: University Hospitals Case Medical Center

location_facility: Centennial Center-Comprehensive Clinical Research

location_facility: Centre de Recherche Dermatologique du Québec Métropolitain

location_facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa

location_facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki

location_facility: Clinical hospital of emergency care N.V. Soloviev

location_facility: Dres. Kirsten Prepeneit und Volker Streit

location_facility: Hud kliniken- Skanes Universitetssjukhus i Malmo

location_facility: Oddelenie biologickej liecby, Narodny ustav reumatickych chorob

location_facility: Saint Louis University - Department of Dermatology

location_facility: Colegio Mayor de Nuestra Señora del Rosario

location_facility: Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary

location_facility: Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: UMHAT "Dr. Georgi Stranski" - II clinical base

location_facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly

location_facility: Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin

location_facility: NorthShore University Health System - Division of Dermatology

location_facility: Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ

location_facility: CENIT Centro de Neurociencias Investigacion y Tratamiento

location_facility: Specjalistyczne Gabinety Lekarskie "Dermed"

location_facility: Hospital General Universitario de Alicante

location_facility: SI 'Institute for Dermatology and Venerology of AMS of Ukraine'

location_facility: Rivergate Dermatology Clinical Research Center, PLLC

location_facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: LKH Salzburg, Landesklinik fuer Dermatologie

location_facility: University General Hospital of Ioannina / Dermatology and Venereology Department

location_facility: Krajska zdravotni a.s.,Masarykovy nemocnice o.z.

location_facility: North-Western State Medical University I.I. Mechnikov

location_facility: Centro Internacional de Estudios Clinicos, CIEC

location_facility: Taipei Medical University-Shuang Ho Hospital

location_facility: Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)

location_facility: Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Leavitt Medical Associates of Florida dba Ameriderm Research

location_facility: Eastern Canada Cutaneous Research Associates Ltd.

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)

location_facility: Dermatovenerologic dispensary #10 of Vyborg region

location_facility: Dept of Dermatology and Venerology of Lugansk State Medical University,

location_facility: Centro Integral de Reumatologia del Caribe Cicaribe S.A.S

location_facility: Mexico Centre for Clinical Research S.A. de C.V.

location_facility: Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: Hopital Larrey Departement de Dermatologie

location_facility: University of North Carolina at Chapel Hill- Hospital

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit

location_facility: The Guenther Dermatology Research Centre

location_facility: Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn

location_facility: Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly

location_facility: International Dermatology Research, Inc.

location_facility: Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn

location_facility: Office of Dr. Paul Adam (back-up location)

location_facility: Atlanta Dermatology, Vein & Research Center, P.C.

location_facility: Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"

location_facility: University Dermatology Clinic "Andreas Syggros" Hospital

location_facility: Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter

location_facility: SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

location_facility: Michigan Center for Research Corporation dba Michigan Center for Skin Care Research

location_facility: Centro De Investigaciones Dermatologicas

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly

location_facility: Dr. Zohair Tomi PMC Inc. Paton Medical Centre

location_facility: Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles

location_facility: University Hospitals Case Medical Center/Dept. of Dermatology

location_facility: Baker Allergy Asthma and Dermatology Research Center, LLC

location_facility: MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"

location_facility: DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

location_facility: University of Pittsburgh Medical Center - Department of Dermatology

location_facility: Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly

location_facility: Rostov-on-Don regional dermatovenerologic dispensary

location_facility: State Research Center of Dermatovenerology,

location_facility: Facharzt fuer Dermatologie und Allergologie


title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

summary:
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.

The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
United States
Philippines
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Malaysia
Sweden
Canada
Guatemala
China
Germany
Greece
Ireland
Korea, Republic of
France
Chile
Netherlands

location_facility: MedStar Good Samaritan Hospital-Oncology Research ( Site 0069)

location_facility: The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620)

location_facility: Institut de Cancérologie de l'Ouest ( Site 0907)

location_facility: Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906)

location_facility: Guy's & St Thomas' NHS Foundation Trust ( Site 1501)

location_facility: Medizinische Universität Wien ( Site 1601)

location_facility: National Cancer Center-Center for Breast Cancer ( Site 2404)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0154)

location_facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332)

location_facility: University of Illinois at Chicago ( Site 0061)

location_facility: Centro de Oncología e Investigación de Buenos Aires ( Site 0400)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009)

location_facility: Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026)

location_facility: Northwest Medical Specialties, PLLC ( Site 0008)

location_facility: Medizinische Universitaet Innsbruck ( Site 1602)

location_facility: Xiangya Hospital Central South University-Breast department ( Site 2621)

location_facility: Juntendo University Hospital ( Site 2210)

location_facility: Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262)

location_facility: North York General Hospital ( Site 0108)

location_facility: The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604)

location_facility: Instituto Nacional del Cancer-CR Investigación ( Site 0511)

location_facility: Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003)

location_facility: Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1110)

location_facility: Hyogo Medical University Hospital ( Site 2201)

location_facility: St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905)

location_facility: General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1700)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 2403)

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904)

location_facility: Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067)

location_facility: Institut de Cancérologie de l'Ouest ( Site 0915)

location_facility: Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902)

location_facility: Henan Cancer Hospital-Galactophore Department ( Site 2615)

location_facility: Baptist MD Anderson Cancer Center ( Site 0013)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629)

location_facility: Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203)

location_facility: Tokyo Medical University Hospital ( Site 2206)

location_facility: Peking University Shenzhen Hospital-Oncology Department ( Site 2601)

location_facility: Providence Portland Medical Center ( Site 0038)

location_facility: Kitasato University Hospital ( Site 2204)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351)

location_facility: Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803)

location_facility: Sanford Fargo Medical Center ( Site 0040)

location_facility: Princess Margaret Cancer Centre ( Site 0101)

location_facility: Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610)

location_facility: Centre Hospitalier de l'Université de Montréal ( Site 0105)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111)

location_facility: Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612)

location_facility: Christus Muguerza Clinica Vidriera ( Site 0253)

location_facility: Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503)

location_facility: University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052)

location_facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (

location_facility: St. Luke's International Hospital ( Site 2207)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901)

location_facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333)

location_facility: New England Cancer Specialists ( Site 0007)

location_facility: Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue (

location_facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812)

location_facility: Seoul National University Bundang Hospital ( Site 2406)

location_facility: Fukushima Medical University ( Site 2200)

location_facility: Westmead Hospital-Department of Medical Oncology ( Site 2101)

location_facility: Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609)

location_facility: Jiangsu provincial people's hospital-Oncology Department ( Site 2607)

location_facility: N.N.Petrov Research Institute of Oncology ( Site 1900)

location_facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2002)

location_facility: University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303)

location_facility: Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis

location_facility: Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)

location_facility: Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020)

location_facility: Lux med onkologia sp. z o.o. ( Site 1808)

location_facility: Orchard Healthcare Research Inc. ( Site 0037)

location_facility: Hematology Oncology Associates of Rockland ( Site 0044)

location_facility: University of Alabama at Birmingham-Medicine ( Site 0065)

location_facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 2102)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403)

location_facility: Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355)

location_facility: Centre de Cancérologie du Grand Montpellier ( Site 0912)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 2401)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0513)

location_facility: Maastricht UMC+-Medical Oncology ( Site 1353)

location_facility: Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2209)

location_facility: Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604)

location_facility: University Malaya Medical Centre ( Site 2505)

location_facility: Hygeia Hospital-3rd Oncology Department ( Site 0304)

location_facility: Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005)

location_facility: Breast Cancer Research Centre-WA ( Site 2104)

location_facility: University Cancer & Blood Center, LLC ( Site 0032)

location_facility: Beijing Cancer hospital-Department of Breast Cancer ( Site 2605)

location_facility: CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800)

location_facility: MedStar Washington Hospital Center ( Site 0063)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113)

location_facility: Instituto de Oncología de Rosario ( Site 0401)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811)

location_facility: Saitama Medical University International Medical Center ( Site 2208)

location_facility: Kadlec Clinic Hematology and Oncology ( Site 0055)

location_facility: St. Marianna University School of Medicine Hospital ( Site 2205)

location_facility: Waverly Hematology Oncology ( Site 0015)

location_facility: Jilin Cancer Hospital-oncology department ( Site 2619)

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200

location_facility: Fudan University Shanghai Cancer Center-Oncology ( Site 2600)

location_facility: Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066)

location_facility: University of Tennessee Medical Center ( Site 0039)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 2000)

location_facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616)

location_facility: West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630)

location_facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)

location_facility: The Royal Cornwall Hospital ( Site 1507)

location_facility: Sarawak General Hospital-Radiotherapy Unit ( Site 2501)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320)

location_facility: Shandong Cancer Hospital-Breast surgery ( Site 2623)

location_facility: Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00

location_facility: Podolsk Regional Clinical Hospital ( Site 1907)

location_facility: Central Clinical Hospital of the Presidential Administrative Department ( Site 1904)

location_facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625)

location_facility: Assuta Ashdod Medical Center ( Site 1703)

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901)

location_facility: The Third Hospital of Nanchang-Oncology Dept ( Site 2628)

location_facility: Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506)

location_facility: Sourasky Medical Center-Oncology ( Site 1701)

location_facility: Arizona Oncology Associates-Arizona Oncology ( Site 0049)

location_facility: Ege University Medicine of Faculty ( Site 2004)

location_facility: Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062)

location_facility: Oregon Health and Science University ( Site 0031)

location_facility: Anhui Cancer Hospital-medical oncology ( Site 2632)

location_facility: Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 0252)

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004)

location_facility: Moscow Clinical Research Center-Chemotherapy department ( Site 1903)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013)

location_facility: Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624)

location_facility: Centro Estatal de Cancerologia-Investigación ( Site 0256)

location_facility: Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202)

location_facility: St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531)

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114)

location_facility: Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912)

location_facility: Hospital Británico de Buenos Aires-Oncology ( Site 0404)

location_facility: UCSF Medical Center at Mission Bay ( Site 0043)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 2103)

location_facility: Blackpool Victoria Hospital ( Site 1503)

location_facility: Soroka Medical Center-Oncology ( Site 1702)

location_facility: Bnai Zion Medical Center-Oncology ( Site 1704)

location_facility: Medical Oncology Associates, PS ( Site 0010)

location_facility: Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301)

location_facility: Zhejiang Cancer Hospital-Breast Oncology ( Site 2622)

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (

location_facility: Severance Hospital, Yonsei University Health System ( Site 2400)

location_facility: Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1

location_facility: Gynaekologisches Zentrum Bonn ( Site 1201)


title: A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Sweden
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Hanusch Krankenhaus Wiener Gebietskrankenkasse

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: University Hospitals Monarch Medical Center

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: John Theurer Cancer Center at Hackensack

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD

location_facility: Azienda Ospedaliera Ospedale di Busto Arsizio

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Seoul National University Bundang Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Hospital Universitario Central de Asturias

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST

location_facility: Spitalul Clinic Judetean de Urgenta Tirgu-Mures

location_facility: Universitätsklinikum Frankfurt Goethe Universität

summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.


title: Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.

acronym: MODEL

summary:
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).

There is two types of maintenance :

continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.
switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.

Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.

The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducoloné A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancérologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: APHP - CHU Avicenne - Oncologie Medicale

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire


acronym: AMA

title: A Phase II Trial Evaluating the Activity of Abiraterone Acetate Plus Prednisone in Patients With a Molecular Apocrine HER2-negative Locally Advanced or Metastatic Breast Cancer

lead_sponsor: UNICANCER

ReferenceCitation: Bonnefoi H, Grellety T, Tredan O, Saghatchian M, Dalenc F, Mailliez A, L'Haridon T, Cottu P, Abadie-Lacourtoisie S, You B, Mousseau M, Dauba J, Del Piano F, Desmoulins I, Coussy F, Madranges N, Grenier J, Bidard FC, Proudhon C, MacGrogan G, Orsini C, Pulido M, Gonçalves A. A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1). Ann Oncol. 2016 May;27(5):812-8. doi: 10.1093/annonc/mdw067. Epub 2016 Feb 18.

location_facility: Institut Curie - Hôpital Claudius Regaud

summary: The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.


title: Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study

summary: The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.