title: A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects

acronym: FLAMINGO

summary: This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study.

ReferenceCitation: Molina JM, Clotet B, van Lunzen J, Lazzarin A, Cavassini M, Henry K, Kulagin V, Givens N, de Oliveira CF, Brennan C; FLAMINGO study team. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015 Apr;2(4):e127-36. doi: 10.1016/S2352-3018(15)00027-2. Epub 2015 Mar 10. Erratum in: Lancet HIV. 2015 Apr;2(4):e126.

ReferenceCitation: Clotet B, Feinberg J, van Lunzen J, Khuong-Josses MA, Antinori A, Dumitru I, Pokrovskiy V, Fehr J, Ortiz R, Saag M, Harris J, Brennan C, Fujiwara T, Min S; ING114915 Study Team. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014 Jun 28;383(9936):2222-31. doi: 10.1016/S0140-6736(14)60084-2. Epub 2014 Apr 1. Erratum in: Lancet. 2015 Jun 27;385(9987):2576.

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
Russian Federation
Switzerland
Puerto Rico
United States
France
Romania
Germany


title: OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

summary: This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Boston Scientific Corporation

location_facility:
CHG Albi
CH St. Joseph
CHU Angers
CHU Pontchaillou
CH La Roche sur Yon
Hopital Antoine Beclere
CHU Dupuytren
CHRU Robert Debré
Hopital Neuro-cardiologique
GH La Timone
CHG Pau
CHU Nice
CH Amiens
CHU Tours
CMC Arnaud Tzanck
CHU D'Orleans
Hopital Cote de Nacre
CH Besancon
CHU Clermont Ferrand
CHU Rouen
CHU Nantes
CH Avignon
CHU Rangueil
CHG Aix en Provence
Hopital Nord
CHU Montpellier
CHG Chateauroux
CHU Hopital la Cavale Blanche
Hôpital Princesse de Grâce
CHG Martigues
CHU Michalon
Hopital Angouleme
CHU Toulon

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Short and Long Term Evaluation of Electrical Measurements and Defibrillation Energies, Results of ATP and Diagnostic Functions of Devices Connected to Endotak RELIANCE® Defibrillation Leads

summary: The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.

location_facility:
Clinique St. Gatien
CHU Angers
Hôpital Côte de Nacre
CHU Henri Mondor
CHU Pontchaillou
Clinique Bizet
CHU du Morvan
CHU Brabois
CHG Pau
CHU Nice
Centre cardiologique du Nord
CH Amiens
CH Hôpital Nord
CMC Arnaud Tzanck
Nouvelle Clinique Nantaise
CHU D'Orleans
CHU Rouen
CHU Nantes
CH Avignon
CHU La Timone
CHU Rangueil
CHU Montpellier
Clinique Cardiologique Aressy
CHU Michalon
Hôpital Angoulème


title: Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.

summary: To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Pfizer

intervention_type: Drug


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

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

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

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

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

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

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Ictal Group

location_country:
Brazil
Spain
Mexico
France
United States
Colombia
Egypt

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Centre Hospitalier Universitaire Henri Mondor

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

location_facility: Hospital Regional De Alta Especialidad Del Bajío

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

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire Hôpital Edouard Herriot

location_facility: Centre Hospitalier Universitaire Beaujon

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Régional Universitaire de Brest

location_facility: Fundación Valle del Lili, University Hospital

location_facility: Centre Hospitalier Universitaire Louis Mourier

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Other

status_simplified: Unknown


type: EudraCT Number

title: Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm

summary: To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

ReferenceType: derived

ReferenceCitation: Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4.

location_facility: Groupe hospitalier Est- Hôpital Femme, Mère, Enfant

location_facility: Service de Pédiatrie- Centre Hospitalier Intercommunal

location_facility: Groupe hospitalier Est-Hôpital Femme, Mère, Enfant

location_facility: CHU Tours - Centre Pediatrique Gatien de Cocheville

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie


title: Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts

summary: To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary


title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Forced Titration Study Of The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Compared To Fenofibrate In Subjects With Fredrickson Type IIB Dyslipidemia (Mixed Hyperlipidemia

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To assess the HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.

design_allocation: Randomized


title: Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility

summary: Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

ReferenceType: background

ReferenceCitation: Fernandez H, Gervaise A. Ectopic pregnancies after infertility treatment: modern diagnosis and therapeutic strategy. Hum Reprod Update. 2004 Nov-Dec;10(6):503-13. Epub 2004 Sep 23. Review.

ReferenceCitation: Bourel G, Pelletier-Fleury N, Bouyer J, Delbarre A, Fernandez H, Capmas P. Cost-effectiveness analysis of medical management versus conservative surgery for early tubal pregnancy. Hum Reprod. 2019 Feb 1;34(2):261-267. doi: 10.1093/humrep/dey352.

ReferenceCitation: Fernandez H, Capmas P, Lucot JP, Resch B, Panel P, Bouyer J; GROG. Fertility after ectopic pregnancy: the DEMETER randomized trial. Hum Reprod. 2013 May;28(5):1247-53. doi: 10.1093/humrep/det037. Epub 2013 Mar 12.

lead_sponsor: Hopital Antoine Beclere

location_facility: Assistance Publique Hôpitaux de Marseille ; Hôpital Nord

location_facility: Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception

location_facility: Versailles Hospital ; Hôpital André Mignot

intervention_type: Procedure

lead_sponsor_type: academique


title: Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

ReferenceType: result

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

ReferenceCitation: Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.

ReferenceCitation: Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017.

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Centre Hospitalier Universitaire Henri Mondor

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

location_facility: Centre Hospitalier General de Mont de Marsan

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

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.

ReferenceCitation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prisé E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Hopital d'Instruction des Armees du Val de Grace

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

intervention_type: Radiation


title: Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

ReferenceCitation: Gravis G, Fizazi K, Joly F, et al.: Safety results from a phase III trial comparing androgen-deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-naïve metastatic prostate cancer (GETUG-AFU 15/0403). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-43, 2010.

ReferenceCitation: Gravis G, Fizazi K, Joly F, et al.: Randomized phase III study comparing docetaxel and androgen deprivation therapy (ADT) versus ADT alone in androgen dependent metastatic prostate cancer (GETUG-15/0403): a French national muticentric study sponsored by the French Federation des Centres. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-161, 2007.

ReferenceCitation: Trump DL. Commentary on "Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial." Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Théodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M, Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. Lancet Oncol 2013;14(2):149-58 [Epub 2013 Jan 8]. Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011.

ReferenceCitation: Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Théodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.

ReferenceCitation: Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35. Review.

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau


type: Other Identifier

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

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

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

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

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

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

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

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

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

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: ASST Grande Ospedale Metropolitano Niguarda

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

location_facility: A.O. Universitaria Ospedali Riuniti di Ancona

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

location_facility: Instituto Catalan Deoncologia Hospital Duran I Reynals

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

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

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

location_facility: New York Presbyterian-Weill Cornell Medical College

location_facility: Attikon University General Hospital of Attica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Oslo universitetssykehus HF, Rikshospitalet

location_facility: University Hospitals Birmingham NHS Trust,

location_facility: Harvard Medical School-Beth Israel Deaconess Medical Center

location_facility: University of Texas Southwestern Medical Center

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

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

status_simplified: Ongoing


type: Registry Identifier

title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

summary:
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus.

Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

ReferenceCitation: Nakayama Y, Kosek J, Capone L, Hur EM, Schafer PH, Ringheim GE. Aiolos Overexpression in Systemic Lupus Erythematosus B Cell Subtypes and BAFF-Induced Memory B Cell Differentiation Are Reduced by CC-220 Modulation of Cereblon Activity. J Immunol. 2017 Oct 1;199(7):2388-2407. doi: 10.4049/jimmunol.1601725. Epub 2017 Aug 28.

ReferenceCitation: Lipsky PE, Vollenhoven RV, Dörner T, Werth VP, Merrill JT, Furie R, Petronijevic M, Velasco Zamora B, Majdan M, Irazoque-Palazuelos F, Terbrueggen R, Delev N, Weiswasser M, Korish S, Stern M, Hersey S, Ye Y, Gaudy A, Liu Z, Gagnon R, Tang S, Schafer PH. Biological impact of iberdomide in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 Apr 27. pii: annrheumdis-2022-222212. doi: 10.1136/annrheumdis-2022-222212. [Epub ahead of print]

ReferenceCitation: Merrill JT, Werth VP, Furie R, van Vollenhoven R, Dorner T, Petronijevic M, Velasco J, Majdan M, Irazoque-Palazuelos F, Weiswasser M, Korish S, Ye Y, Gaudy A, Schafer PH, Liu Z, Agafonova N, Delev N. Phase 2 Trial of Iberdomide in Systemic Lupus Erythematosus. N Engl J Med. 2022 Mar 17;386(11):1034-1045. doi: 10.1056/NEJMoa2106535.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

lead_sponsor: Celgene

location_country:
Poland
Brazil
Serbia
Spain
Colombia
Italy
Mexico
Russian Federation
Argentina
Canada
Hungary
United States
France
Belgium
Germany

location_facility: Centro de Investigación y Tratamiento Reumatológico

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.

location_facility: Reumalab - Centro Integral de Reumatologia

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S

location_facility: Azienda Ospedaliero - Universitaria di Cagliari

location_facility: Centro de Estudos em Terapias Inovadoras LTDA

location_facility: Advanced Rheumatology & Arthritis Research Center, PC

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

location_facility: Unidad de Atencion Medica e Investigacion en Salud, S.C.

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR

location_facility: University of Pennsylvania Department of Dermatology

location_facility: Saint Petersburg Research Institute for Emergency Medical Care

location_facility: Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: University of Pittsburgh UPMC Lupus Center of Excellence

location_facility: University of California San Diego Medical Center

location_facility: Instituto de Investigaciones Clinicas de Quilmes

location_facility: University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna

location_facility: Centro de Imunoterapia de Ipanema (CITIPA)

location_facility: University of Maryland - School of Medicine

location_facility: Clinique de Rhumatologie Du Centre Du Quebec

location_facility: Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina

location_facility: Centro Integral en Reumatología, S.A. de C.V.

location_facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

location_facility: University of Florida College of Medicine

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: Hospital Universitario Araba - Txagorritxu

location_facility: Consultora Integral de Salud Centro Médico Privado

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

location_facility: North Shore-LIJ Health System-Division of Rheumatology

location_facility: Centro de Investigacion en Artritis y Osteoporosis

location_facility: Hospital General de Agudos Dr. Jose Maria Ramos Mejia


title: Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

summary:
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

status: Active, not recruiting

ReferenceCitation: Fizazi K, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houedé N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Fléchon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Lagrange JL, Chinet-Charrot P, Linassier C, Deplanque G, Beuzeboc P, Geneve J, Davin JL, Tournay E, Culine S. A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial. Eur J Cancer. 2012 Jan;48(2):209-17. doi: 10.1016/j.ejca.2011.10.015. Epub 2011 Nov 24.

ReferenceCitation: Fizazi K, Lesaunier F, Delva R, et al.: A phase III trial of docetaxel-estramustine in high-risk localized prostate cancer (GETUG 12 trial): design, tolerance, response, and quality of life (QOL). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-7, 2010.

ReferenceCitation: Fizazi K, Gravis G, Culine S: The GETUG 12 trial, a phase III randomized trial of docetaxel-estramustine in high-risk localized prostate cancer: clinical design and current status. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-153, 2006.

ReferenceCitation: Fizazi K, Faivre L, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Fléchon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Chinet-Charrot P, Legouffe E, Lagrange JL, Linassier C, Deplanque G, Beuzeboc P, Davin JL, Martin AL, Habibian M, Laplanche A, Culine S. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28.

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Universitaire Henri Mondor

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

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


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

acronym: IBIS-II DCIS

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

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

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

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

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

lead_sponsor: Queen Mary University of London

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

location_facility: Royal Infirmary of Edinburgh at Little France

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Austrian Breast & Colorectal Cancer Study Group

location_facility: Centre Hospitalier Universitaire Vaudois

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

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

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


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

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

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

location_facility: Royal Liverpool and Broadgreen Hospitals

location_facility: Haukeland Hospital - University of Bergen

location_facility: Queen Elizabeth Hospital at University of Birmingham

location_facility: Klinik der Justus - Leibig - Universitaet Giessen

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Institute of Oncology at Prince of Wales Hospital

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

location_facility: Ospedale San Martino/Cliniche Universitarie Convenzionate

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen


title: Conformational, Curative Ratiotherapy For Prostate Cancer (NO, N-): Phase III Multicenter Study Of The Contribution To Survival Without Clinical Or Biological Change With A Dose Variation Of 15% (80 Gy VS 70 Gy)

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer.

ReferenceCitation: Beckendorf V, Guerif S, Le Prisé E, Cosset JM, Bougnoux A, Chauvet B, Salem N, Chapet O, Bourdain S, Bachaud JM, Maingon P, Hannoun-Levi JM, Malissard L, Simon JM, Pommier P, Hay M, Dubray B, Lagrange JL, Luporsi E, Bey P. 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1056-63. doi: 10.1016/j.ijrobp.2010.03.049. Epub 2010 Dec 14.

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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


title: Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

ReferenceCitation: Huguet F, André T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31.

ReferenceCitation: André T, Noirclerc M, Hammel P, Meckenstock R, Landi B, Cattan S, Selle F, Codoul JF, Guerrier-Parmentier B, Mokhtar R, Louvet C; GERCOR. Phase II study of leucovorin, 5-fluorouracil and gemcitabine for locally advanced and metastatic pancreatic cancer (FOLFUGEM 2). Gastroenterol Clin Biol. 2004 Aug-Sep;28(8-9):645-50. Review.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_country: France Luxembourg

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

location_facility: L'Institut Mutualiste Montsouris Jourdan

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud


title: Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie


title: Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

location_facility: Hopital Desgenettes - Service de Medecine Interne


title: First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

location_facility: Centre Hospitalier Departmental Felix Guyon


title: Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

ReferenceCitation: Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouché O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29.

ReferenceCitation: Côté JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. Epub 2007 May 17.

location_facility: Centre Hospitalier de Bourgoin - Jallieu

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer.

intervention_type: Biological


title: Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy.

status: Terminated

location_facility: Hopital d'Instruction des Armees du Val de Grace


title: Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.

ReferenceCitation: Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11.

location_facility: Centre Hospitalier Regional Metz Thionville

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

location_facility: Centre Hospitalier General de Saint Nazaire


title: Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.

ReferenceCitation: Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73.

ReferenceCitation: Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.

location_facility: Clinique de la Sauvegarde - Clinique Jeanne D'Arc


title: A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. It is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more effective than standard therapy for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women who have locally recurrent or metastatic breast cancer.

ReferenceCitation: Biron P, Durand M, Roché H, Delozier T, Battista C, Fargeot P, Spaeth D, Bachelot T, Poiget E, Monnot F, Tanguy ML, Curé H. Pegase 03: a prospective randomized phase III trial of FEC with or without high-dose thiotepa, cyclophosphamide and autologous stem cell transplantation in first-line treatment of metastatic breast cancer. Bone Marrow Transplant. 2008 Mar;41(6):555-62. Epub 2007 Nov 26.

ReferenceCitation: Biron P, Durand M, Roche H, et al.: High dose thiotepa (TTP), cyclophosphamide (CPM) and stem cell transplantation after 4 FEC 100 compared with 4 FEC alone allowed a better disease free survival but the same overall survival in first line chemotherapy for metastatic breast cancer: results of the PEGASE 03 French protocole. [Abstract] Proceedings of the American Society of Clinical Oncology A-167, 2002.

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Federation Nationale des Centres de Lutte Contre le Cancer


title: PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for small cell lung cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil


title: Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study

acronym: THEMIS

summary: The emergence of targeted therapy (ibrutinib, venetoclax, acalabrutinib) has revolutionized the management practices of chronic lymphoid leukemia due to their effectiveness. However, targeted therapy induces a significant additional cost compared to treatment with immunochemotherapy and their use can be problematic due to the frequent occurrence of side effects, which can be serious. In order to improve the current management of patients treated with targeted therapy, the aim of this study is to evaluate the ambulatory medical assistance nurse program. Ambulatory medical assistance is based on regular telephone calls to patient's homes by a specialist nurse and consists of the monitoring, detection and early management of possible adverse effects of targeted therapy, in link with the hematologist. The main objective of this clinical research is to determine efficiency of the ambulatory medical assistance nurse program.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital Estaing
Hôpital Bretonneau
CH du Mans
Hôpital Emile MULLER
CHRU Dijon
Hôpital Saint-Louis
CHU d'Angers
CHRU de Nancy
Centre Léon Bérard
CHU de Reims- Hôpital R.Debré
CH Bretagne Atlantique Vannes
Institut de Cancérologie du Gard
Centre Hospitalier Lyon sud
CHU de RENNES
CHU DE BREST Hôpital A.Morvan
CH Sud Réunion


title: Auvergne-Rhône-Alpes-Limousin Research Database for Still's Diseases in Children and Adults

acronym: AURAL-STILL

summary:
Adult-Onset Still's disease is a polygenic autoinflammatory disease of unknown etiology. The autoinflammatory character individualizes it from autoimmune autoantibody diseases. Clinically, it results in the classic triad associating hectic fever, evanescent rash and arthritis. Although it is benign in the vast majority of cases, life-threatening complications can occur. By definition, the disease affects adults over 16 years of age, however most experts now agree that the adult form and the pediatric form belong to a pathological continuum: Still's disease. In the absence of a specific biomarker, the diagnosis is still based on clinical and biological criteria, after the exclusion of differential diagnoses.

Classically, three evolutionary profiles of Adult-Onset Still's disease are individualized, depending on the evolution of symptoms over time:

a monocyclic systemic form (30% of cases) characterized by clear systemic symptoms and in the foreground compared to the articular signs. This form evolves over several weeks to several months (on average 9 months), without exceeding a year. By definition, there is no recurrence;
a polycyclic systemic form (30% of cases) defined by the occurrence of at least two systemic or joint episodes, separated by clinical remission intervals greater than two months, or even several years. The symptoms of relapses are not always the same as the initial symptoms. The number and severity of relapses is unpredictable and varies widely from patient to patient, but symptoms tend to become less severe over time.
a chronic form, with predominant joint involvement (40%), resembling seronegative rheumatoid arthritis. Systemic signs are present during the first outbreaks of the disease. Subsequently, rheumatoid arthritis evolves on its own and one can see joint destruction or conversely ankylosing developments such as the classic bilateral, non-erosive fusing carpitis.

There are reasons to believe that the evolving profile of patients has changed since the emergence and generalization of biotherapies. Furthermore, no prognostic factor for the progression of Adult-Onset Still's disease has been found so far. The differences between pediatric and adult forms need to be confirmed and becoming pediatric forms in adulthood is poorly described.

The objective of this study is to set up a regional research database (Auvergne-Rhône-Alpes-Limousin) in order to describe the characteristics, treatment and evolution of patients with Still's disease.

ipd_sharing_description: The individual participant data will not be shared

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Edouard Herriot


title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for up to an Additional Two Years of Treatment and an Open-Label Extension With Active Study Treatment

acronym: Scarlet Road

summary:
This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020.

The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.

ReferenceCitation: Klein G, Delmar P, Voyle N, Rehal S, Hofmann C, Abi-Saab D, Andjelkovic M, Ristic S, Wang G, Bateman R, Kerchner GA, Baudler M, Fontoura P, Doody R. Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimers Res Ther. 2019 Dec 12;11(1):101. doi: 10.1186/s13195-019-0559-z.

ReferenceCitation: Ostrowitzki S, Lasser RA, Dorflinger E, Scheltens P, Barkhof F, Nikolcheva T, Ashford E, Retout S, Hofmann C, Delmar P, Klein G, Andjelkovic M, Dubois B, Boada M, Blennow K, Santarelli L, Fontoura P; SCarlet RoAD Investigators. A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease. Alzheimers Res Ther. 2017 Dec 8;9(1):95. doi: 10.1186/s13195-017-0318-y. Erratum in: Alzheimers Res Ther. 2018 Sep 27;10(1):99.

ReferenceCitation: Delrieu J, Ousset PJ, Vellas B. Gantenerumab for the treatment of Alzheimer's disease. Expert Opin Biol Ther. 2012 Aug;12(8):1077-86. doi: 10.1517/14712598.2012.688022. Epub 2012 May 15. Review. Retraction in: Expert Opin Biol Ther. 2021 Dec;21(12):1-2.

RetractionSource: Expert Opin Biol Ther. 2021 Dec;21(12):1-2

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Turkey
Mexico
Sweden
Brazil
Canada
Switzerland
Germany
Denmark
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Hospital das Clinicas - FMUSP; Psiquiatria

location_facility: St. Anne´s University Hospital; Clinical Trials Department

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building

location_facility: Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

location_facility: Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

location_facility: Universita' Di Parma Istituto Neurologia

location_facility: Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Univ Berlin; Klin fur Psychi & Psycho Charite

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Estimulacion Magnetica Trnscraneal de Mexico SC.

location_facility: Victoria Centre; Kingshill Research Centre

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique

location_facility: PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER

location_facility: Campus for Ageing & Vitality; Clincal Ageing Research Unit

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Office of Dr Klaus Steinwachs Neurology & Psychiatry

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Australian Alzheimer's Research Foundation

location_facility: Charing Cross Hospital; Dept of Neurosciences

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

location_facility: Hospital das Clinicas - UFPR; Ciencias da Saude

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

location_facility: Universidade Federal de Sao Paulo - UNIFESPX; Neurologia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

location_facility: Seoul National University Bundang Hospital; Neurology Department

location_facility: Hospital Universitario; Dr. Jose E. Gonzalez

location_facility: Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere

location_facility: Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie

location_facility: Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center

location_facility: Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1

location_facility: Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Instituto De Neurología Cognitiva - INECO

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Hop Guillaume Et Rene Laennec; Cmrr St Herblain

location_facility: ALPI-Inst. de Rehabilitacion Marcelo Fitte

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

location_facility: Prince of Wales Hospital, Academic Department for Old Age Psychiatry

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Royal Adelaide Hospital; Memory Trials Centre

location_facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr

location_facility: IME - Instituto Médico Especializado; Ensayos Clínicos

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

location_facility: Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care

location_facility: University of Rochester Medical Center; Monroe Community Hospital

location_facility: CHU De Caen; Service De Neurologie Dejerine

location_facility: Akdeniz University School of Medicine, Neurology Department


title: Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children

summary:
Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia.

Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines.

Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.

location_facility:
University Hospital of Nice
University hospital of Angers
University hospital of Limoges
University hospital of Poitiers
University hospital of Saint-Etienne
Hôpital La Timone
University hospital of Rouen
University hospital of Grenoble
University Hospital of Tours
University hospital of Reims
University hospital of Toulouse
University hospital of Strasbourg
Armand Trousseau Hospital
University hospital of Nancy
University hospital of Lille
University hospital of Besançon


title: Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?

acronym: FERTICOVID

summary: During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye

location_facility: CHU de Clermont-Ferrand - Laboratoire de Virologie

location_facility: AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction

location_facility: CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS

location_facility: CHU de Strasbourg - Service de Biologie de la reproduction

location_facility: CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS

location_facility: AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction

location_facility: Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS

location_facility: Hospices Civils de Lyon - Service AMP-CECOS

location_facility: CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS

location_facility: CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims

location_facility: CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS

location_facility: AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS

location_facility: AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS

intervention_type: Diagnostic Test


title: A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENERALIZED SEIZURES.

lead_sponsor: UCB Pharma

source: euctr

location_country:
Poland
Hungary
United States
France
Mexico

summary: SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in children with epilepsy syndromes associated with generalized seizures. LCM will be added to current antiepileptic treatment.


title: CPX-351 in Higher Risk Myelodysplastic Syndromes: a Phase I/ II Study as First Line or After Hypomethylating-agents Failure

summary: Study of the efficacy of CPX-351 treatment in patients with higher risk myelodysplastic syndromes : as first line treatment or after hypomethylating agents failure

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: CHU de Grenoble - Clinique universitaire d'hématologie

location_facility: CHU de Bordeaux - Hôpital de Haut-Lévêque - Service des maladies du sang

location_facility: CHRU de Limoges - Hôpital Dupuytren - Service d'hématologie clinique et thérapie cellulaire

location_facility: CHU de Poitiers - Service d'onco-hématologie et thérapie cellulaire

location_facility: CHU de Besançon - Hôpital Jean Minjoz - Service d'hématologie clinique

location_facility: CHU d'Angers - Service des maladies du sang

location_facility: CHU d'Amiens - Service d'hématologie clinique et thérapie cellulaire

location_facility: Centre hospitalier Victor Dupouy - Service d'Hématologie

location_facility: CHU Hôtel Dieu - Service d'Hématologie Clinique

location_facility: Hôpital Saint Louis - Service Hématologie Séniors

location_facility: Hôpital Pontchaillou - Service d'hématologie clinique

location_facility: Institut de Cancérologie Lucien Neuwirth - Hématologie Clinique - Thérapie Cellulaire

location_facility: IUCT-oncopole - Fédération Hématologie - Médecine Interne

location_facility: CHU-Hôpital Archet I - Service d'Hématologie Clinique

location_facility: Institut Paoli Calmettes - Unité d'hématologie 3


title: Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure

acronym: APPLIMONCOEUR

summary: Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. The possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.

primary_purpose: Supportive Care

lead_sponsor: French Cardiology Society

location_facility: Centre Médico-Chirurgical - Pôle Santé Sud


title: Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia

acronym: MVO

summary:
Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children.

The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Angers

location_facility:
Univesity Hostipal of Amiens
University Hospital of Nice
University of Brest
University Hospital of Limoges
University Hospital of Nantes
Hôpital La Timone
University Hospital of Rennes
University Hospital of Tours
Hôpital Trousseau
Centre Oscar Lambret
University Hospital of La Réunion
University Hospital of Poitiers
Institut Curie
University Hospital of Bordeaux
University Hospital of Dijon
Gustave Roussy


title: A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

summary: IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.

lead_sponsor: Infinity Pharmaceuticals, Inc.

location_country:
Poland
United Kingdom
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
Sweden
United States
France
Norway
Germany

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: Centre Léon Bérard, Service d'Oncologie Médicale

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie

location_facility: (TGen) Translational Genomics Research Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies


title: A Phase III, Double-blind, Placebo-controlled, Randomised Withdrawal, Multicentre, Extension, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention- Deficit/Hyperactivity Disorder (ADHD)

lead_sponsor: Shire

ReferenceCitation: Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P, Squires LA, Coghill DR. Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2014 Dec;28(12):1191-203. doi: 10.1007/s40263-014-0193-z.

ReferenceCitation: Coghill DR, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson CS, Civil R, Dauphin M, Higgins N, Lyne A, Gasior M, Squires LA. Maintenance of efficacy of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder: randomized-withdrawal study design. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):647-657.e1. doi: 10.1016/j.jaac.2014.01.017. Epub 2014 Mar 4.

location_country:
Poland
United Kingdom
Italy
Sweden
Hungary
United States
France
Belgium
Germany

location_facility: Universitätsklinikum Gießen und Marburg GmbH, Universitätsklinikum Gießen und Marburg GmbH, Hans-Sachs-Straße 4,

location_facility: Zentralinstitut für Seelische Gesundheit Mannheim

location_facility: Azienda Ospedaliera della 2? Universita di Napoli

location_facility: ZNA Antwerpen, Commandant Weynsstraat 165

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

location_facility: Azienda Ospedaliera Policlinico Consorziale

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

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

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Poradnia Psychiatryczna, ul. Marszalkowska 24,

location_facility: Northampton Child and Adolescent Mental Health Services

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke

location_facility: Basildon Hospital - Child Development Centre,

location_facility: Schwerpunktpraxis für Entwicklung und Lernen

location_facility: Wojewódzki Osrodek Lecznictwa Psychiatrycznego

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Universität zu Köln, Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes und Jugendalters

location_facility: Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó

location_facility: Universitair Ziekenhuis Gent, Kinder - en Jeugdpsychiatrie

location_facility: Drottning Silvias Barnsjukhus, Otterhällegatan 12A

location_facility: East Kent NHS and Social Care Partnership Trust

summary: The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months


title: A Randomized, Placebo-controlled, Double-blinded, Multicentre Study Evaluating the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

acronym: REGOSTA

summary:
This is a randomized, double-blinded, 2 arms study concerning patients with bone sarcoma after the first line therapy.

In the first arm, patients will be treated with regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be treated with placebo (standard of care).

The comparison between this two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Régional de Strasbourg Hautepierre

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de Saint-Etienne (CHUSE)

location_facility: Institut de Cancérologie Strasbourg Europe


acronym: CTCL

title: A Randomized, Double-blind, Multi-centre, Placebo-controlled, Parallel-arm Phase 2 Trial to Assess Safety, Efficacy and Pharmacokinetics of CD11301 0.03% and 0.06% Gel in the Treatment of Cutaneous T-Cell Lymphoma (CTCL), Stages IA, IB and IIA

lead_sponsor: Galderma R&D

ReferenceCitation: Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3.

ipd_sharing_description: No intent to share information.

location_country:
Germany
United States
France

summary: To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).


title: An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)

summary: This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.

ReferenceCitation: Bannerji R, Arnason JE, Advani RH, Brown JR, Allan JN, Ansell SM, Barnes JA, O'Brien SM, Chávez JC, Duell J, Rosenwald A, Crombie JL, Ufkin M, Li J, Zhu M, Ambati SR, Chaudhry A, Lowy I, Topp MS. Odronextamab, a human CD20×CD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial. Lancet Haematol. 2022 May;9(5):e327-e339. doi: 10.1016/S2352-3026(22)00072-2. Epub 2022 Apr 1.

ReferenceCitation: Zhu M, Olson K, Kirshner JR, Khaksar Toroghi M, Yan H, Haber L, Meagher C, Flink DM, Ambati SR, Davis JD, DiCioccio AT, Smith EJ, Retter MW. Translational findings for odronextamab: From preclinical research to a first-in-human study in patients with CD20+ B-cell malignancies. Clin Transl Sci. 2022 Apr;15(4):954-966. doi: 10.1111/cts.13212. Epub 2022 Jan 7.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
United Kingdom
United States
Israel
France
Germany

location_facility: Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)


title: Validation Trial for a Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease

acronym: RH-VAL

summary: The purpose of this study is to validate a diagnostic test that combines different blood markers to identify and correctly classify patients with Alzheimer's disease (AD) compared to individuals with behavioural variant frontotemporal dementia (bvFTD, patient control) versus cognitively healthy individuals (healthy control).

lead_sponsor: Raman Health Technologies, S.L.

location_country: France Spain Belgium

location_facility: Centre Mémoire paris Nord Ile de France GH Saint-Louis Lariboisière Fernand Widal

location_facility: Cognitive and Behavioral Disease Center and Alzheimer's Institute


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

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

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

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

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

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

lead_sponsor: AbbVie

location_country:
Taiwan
Spain
Italy
United Kingdom
Australia
Korea, Republic of
Israel
France
China
Turkey
Romania
Japan
Germany

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 247840

location_facility: S.C. Radiotherapy Center Cluj SRL /ID# 248639

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 247882

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 248116

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 249068

location_facility: Yonsei University Health System Severance Hospital /ID# 248404

location_facility: Zhongshan Hospital Fudan University /ID# 247771

location_facility: National Cheng Kung University Hospital /ID# 248142

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

location_facility: Keimyung University Dongsan Medical Center /ID# 247371

location_facility: Asklepios Fachkliniken Muenchen-Gauting /ID# 248082

location_facility: Pusan National University Yangsan Hospital /ID# 248489

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 248126

location_facility: Adana Sehir Egitim ve Arastirma Hastanesi /ID# 246089

location_facility: Institutul Oncologic Prof Dr I Chiricuta /ID# 248610

location_facility: West China Hospital, Sichuan University /ID# 247783

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 249018

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

location_facility: Harbin Medical University Cancer Hospital /ID# 248982

location_facility: The Chaim Sheba Medical Center /ID# 243207

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

location_facility: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 248125

location_facility: National Cancer Center Hospital East /ID# 250317

location_facility: Akdeniz Universitesi Tip Fakul /ID# 246092

location_facility: Institut Catala d'Oncologia -Hospital Duran i Reynals /ID# 248117

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

location_facility: Hokkaido University Hospital /ID# 250316

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 246826

location_facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 247828

location_facility: Osaka International Cancer Institute /ID# 251507

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 248143

location_facility: CHU Insular-Materno Infantil /ID# 248121

location_facility: Trakya University Medical Facu /ID# 246083

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 246090

location_facility: Gazi University Medical Faculty /ID# 246086

location_facility: Universitaetsklinikum Giessen /ID# 250462

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

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

location_facility: Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 246084

location_facility: National Cancer Center Hospital /ID# 250319

location_facility: Renmin Hospital of Wuhan University /ID# 249019

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 249156

location_facility: Chongqing University Three Gorges Hospital /ID# 247772

location_facility: ASST Monza/Ospedale San Gerardo /ID# 247584

location_facility: Linkou Chang Gung Memorial Hospital /ID# 248145


title: MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types

acronym: MEDICI

summary:
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.

Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.

Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study.

Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

location_country:
Croatia
Saudi Arabia
Italy
Spain
United States
Romania
Czechia
Poland
Slovenia
Australia
Argentina
Israel
Turkey
Norway
Brazil
Canada
Germany
Taiwan
Greece
Ireland
France
Netherlands

location_facility: Hospital de Clinicas de Porto Alegre /ID# 224274

location_facility: University of Texas Southwestern Medical Center /ID# 223865

location_facility: Hospital Italiano de Buenos Aires /ID# 224153

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 228919

location_facility: Fakultni nemocnice Hradec Kralove /ID# 224089

location_facility: Sociedade Beneficente Israelita Hospital Albert Einstein /ID# 224303

location_facility: Instytut Hematologii i Transfuzjologii /ID# 227039

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Mar /ID# 227038

location_facility: Hospital Clinic de Barcelona /ID# 224804

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 229281

location_facility: Hadassah Medical Center-Hebrew University /ID# 224884

location_facility: Hospital Universitario 12 de Octubre /ID# 225617

location_facility: Princess Noorah Oncology Center /ID# 224968

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 225515

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 224608

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690

location_facility: Maastricht Universitair Medisch Centrum /ID# 224694

location_facility: Hospital Universitario de Salamanca /ID# 224803

location_facility: Klinicki bolnicki centar Zagreb /ID# 226969

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 223702

location_facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305

location_facility: Instituto COI de Educacao e Pesquisa /ID# 224245

location_facility: Taichung Veterans General Hospital /ID# 227084

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 229524


title: Coffee Consumption and NASH in the French Population.

acronym: COCANASH

summary: The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier Intercommunal de Créteil


title: A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

summary: This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

ReferenceCitation: D'Haens G, Panés J, Louis E, Lacerda A, Zhou Q, Liu J, Loftus EV Jr. Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27.

location_country:
Denmark
Poland
Romania
Spain
Italy
United Kingdom
Netherlands
New Zealand
Canada
Hungary
United States
France
Israel
Belgium
Norway
Germany
Slovakia
Czechia

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 149989

location_facility: Cabinet Particular Policlinic Algomed /ID# 149993

location_facility: Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 149930

location_facility: Kansas City Research Institute /ID# 149888

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 149882

location_facility: Investigative Clinical Research /ID# 149886

location_facility: Assaf Harofeh Medical Center /ID# 149943

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 149900

location_facility: The Chaim Sheba Medical Center /ID# 149945

location_facility: Options Health Research, LLC /ID# 150010

location_facility: CHU Amiens-Picardie Site Sud /ID# 149921

location_facility: Lovisenberg Diakonale Sykehus /ID# 149967

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 149871

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 149963

location_facility: Hospital Universitario La Paz /ID# 149997

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 149896

location_facility: Washington University-School of Medicine /ID# 149899

location_facility: Toronto Digestive Disease Asso /ID# 149877

location_facility: Centrum Medyczne Szpital Swietej Rodziny /ID# 149979

location_facility: Virginia Mason Medical Center /ID# 150042

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149978

location_facility: Nature Coast Clinical Research - Inverness /ID# 149975

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 149870

location_facility: University of Florida - Archer /ID# 150033

location_facility: Clin Res Inst of Michigan, LLC /ID# 150008

location_facility: Univ California, San Francisco /ID# 149987

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 149873

location_facility: Manchester University NHS Foundation Trust /ID# 150006

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 149897

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 149869

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 149863

location_facility: Universitair Medisch Centrum Utrecht /ID# 149933

location_facility: The Ctr for Gastro Disorders /ID# 150012

location_facility: GIRI Gastrointestinal Research Institute /ID# 149878

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 149976

location_facility: University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936