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

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

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

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

location_facility: Oxford University Hospitals NHS Foundation Trust

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

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

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Fujian Medical University Union Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: University of Texas Southwestern Medical Center

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

location_facility: The second Xiangya Hospital of Central South University

location_facility: West China Hospital, Si Chuan University

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

location_facility: Winship Cancer Institute Emory University


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

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

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: Mhat Sveta Marina; Clinic of Gastroenterology

location_facility: Cantacuzino Clinical Hospital;Gastroenterology Department

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

location_facility: North West Armed Forces Hospital; Internal Medicine

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Hopital Emile Muller; Gastro Enterologie

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

location_facility: The Eighth People's Hospital of Guangzhou

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

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

location_facility: CH Pitie Salpetriere; Hepathologie Gastro Enterologie

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

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

location_facility: Hopital de Pontchaillou; Medicine Interne - Hepatologie

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

location_facility: CHU Hassan 2; Service Gastro Enterologie Pr IBRAHIMI

location_facility: The 1st Affiliated Hospital of Harbin Medical University

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

location_facility: Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny

location_facility: Klinikum Salzgitter-Lebenstedt Medizinische Klinik I

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

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

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

location_facility: Sheikh Zayed Hospital; Department of Gastroentrology

location_facility: Hopital Trousseau; Gastro Enterologie A Et B

location_facility: Central Army Hospital Rspad Gatot Soebroto; Pulmonology

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

location_facility: Bintaro International Hospital, Hepatology

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

location_facility: Bethune International Peace Hospital of PLA

location_facility: Ch De Lagny Sur Marne; Gastro Enterologie

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

location_facility: Cantonal Hospital Bihac; Department for Infective Diseses

location_facility: Hopital Albert Michallon; Gastro Enterologie

location_facility: King Fahad Medical City; Gastroentrology

location_facility: Chiang Mai Uni Hospital; Faculty of Medicine

location_facility: Ch Victor Dupouy; Hepato Gastro Medecine Interne

location_facility: Hospital Geral de Santo Antonio; Servico de Gastrenterologia

location_facility: Yehia Elshazly Clinic for Hepatology and Gastroentrology

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

location_facility: Salmaniya Medical Complex; Gastroenterology

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

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

location_facility: Clinical Infectious Diseases Hospital Victor Babes

location_facility: King Faisal Specialist Hospital & Research Centre; Oncology

location_facility: Liver Clinic Lab-Aid Specialized Hospital

location_facility: Hasan Sadikin Hospital; Digestive Surgery

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

location_facility: Santosa Bandung International Hospital; Hepatology

location_facility: Clinical Hospital Mostar; Department for Gastroenterology

location_facility: Hopital Paul Brousse; Centre Hepatologie Biliaire

location_facility: Holy Family Hospital; Department of Medicine

location_facility: University Clinical Center Tuzla; Clinic for Gastroenterology

location_facility: Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

location_facility: Medizinische Universitätsklinik; Med. Klinik Ii, Infektiologie

location_facility: Dow University of Health Sciences; Department of Medicine

location_facility: American University of Beirut - Medical Center

location_facility: Infektionsmedizinisches Centrum Hamburg ICH Grindel

location_facility: Hopital Henri Mondor; Hepatologie Gastro Enterologie

location_facility: Universitaetsklinikum Essen, Innere Klinik und Poliklinik fuer Tumorforschung

location_facility: Hull Royal Infirmary; Department Hepatology and Gastroenterology

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

location_facility: Songklanagarind Hospital; Division of Gastroenterology

location_facility: Mitra International Jatinegara Hospital; Hepatology

location_facility: Hopital Jacques Monod; Gastro-Enterologie

location_facility: Kyungpook National Uni Hospital; Internal Medicine

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Cipto Mangunkusumo General Hospital; Hematology & Oncology

location_facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

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

location_facility: Cantonal Hospital Zenica; Department for Infective Diseases

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

location_facility: Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

location_facility: Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I

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

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

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

location_facility: Hopital Jean Verdier; Gastro Enterologie

location_facility: Universitätsklinikum Münster Klinik und Poliklinik für Transplantationsmedizin

location_facility: King Fahad University Hospital; Internal Medicine

location_facility: Clinical Center Sarajevo; Gastroenterohepatology

location_facility: Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

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

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Clinical Center Skopje; Gastroenterohepatology

location_facility: Hopital Charles Nicolle; Gastro Enterologie

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

location_facility: Ch Sud Francilien; Cons Gastro Enterologie

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

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

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

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: Nanjing No.2 Hospital; Liver Disease Department

location_facility: Clinical Center Skopje; Infectious Diseases

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

location_facility: Institut Arnault Tzanck; Medecine I Gastro Enterologie

location_facility: Hopital Nord; Reseau Hepatologie Picardie

location_facility: Hopital Antoine Beclere; Hepatologie Gastro Enterologie

location_facility: Dr. Soetomo Hospital; Kidney and Hipertansion

location_facility: Hopital Cote De Nacre; Gastro Enterologie

location_facility: Hopitaux de Brabois - Gastro-Entereologie

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

location_facility: Medical Uni of Bialystok; Infectious Diseases

location_facility: The Second Affiliated Hospital, Chongqing Medical University

location_facility: Universitätsklinikum Klinik f. Gastroenterologie Hepatologie und Infektiologie

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

location_facility: University Clinical Center Tuzla; Clinic for Infective Diseases

location_facility: Hospital de Sao Joao; Servico de Gastrenterologia

location_facility: Wilhelminenspital; Iv. Medizinische Abt.

location_facility: Pomorskie Centrum Chorob Zakaznych i Gruzlicy

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

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 1

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

location_facility: Prince Hamzeh Hospital; Internal Medicine

location_facility: Dres.Dietrich Hüppe Gisela Felten und Heinz Hartmann

location_facility: NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby

location_facility: Fondation Institut Arthur Vernes; Institut Arthur Vernes

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Medical Uni of Lodz; Infectious Diseases

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

location_facility: The Hospital of Tropical and Infectious Disease Victor Babes

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

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

location_facility: Universitätsklinikum Bonn Med. Klinik u. Poliklinik I

location_facility: Clinique De La Sauvegarde; Exploration Gastro Proctologie

location_facility: Hotel-Dieu de France Hospital; Gastroenterology

location_facility: Combined Military Hospital; Department of Medicine

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

location_facility: Clinical Center Banja Luka; Department for Infective Diseases

location_facility: Hospital For Infectious Diseases; Infectiology

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

location_facility: Wojewodzki Szpital; Specjalistyczny Chorob Zakaznych

location_facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

location_facility: Tuen Mun Hospital; Medicine & Geriatrics

location_facility: The Third Hospital of Hebei Medical University

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Uni Heidelberg Med. Klinik; Innere Medizin IV

location_facility: Hopital Saint Andre; Hepato-Gastro-Enterologie

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.

status: Unknown status

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Polyclinique Du Parc Centre Maurice Tubiana

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Clinique Medico Chirurgicale Teissier Groupe

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

location_facility: Centre d'Oncologie et de Radiotherapie du Parc

location_facility: Centre d'Oncologie et de Radiotherapie de Chaumont le Bois

intervention_type: Radiation

status_simplified: Unknown


title: Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospital General Robert Ballanger

location_facility: Hopital d'Instruction des Armes Sainte-Anne

intervention_type: Drug


title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

ReferenceType: background

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.

ReferenceType: result

ReferenceCitation: Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16.


title: Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

ReferenceCitation: Bécouarn Y, Senesse P, Thézenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. Epub 2007 Sep 4.

lead_sponsor: UNICANCER

location_facility: Pole Sante Sarthe et Loir Hopital Pierre Daguet

location_facility: Centre Hospitalier General Lucien Hussel

location_facility: Centre Hospitalier de L' Agglomeration Montargoise


type: Other Identifier

title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer

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

PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.

design_allocation: Non-Randomized

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospital Regional Universitaire de Limoges

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

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Biological


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

acronym: EvTaReaP

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

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

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

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

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

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

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

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

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

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_country: Lebanon France Switzerland Belgium

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

location_facility: Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique

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

location_facility: Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux

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

location_facility: Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes

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

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

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 which combination chemotherapy regimen is more effective in treating early breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.

ReferenceType: derived

ReferenceCitation: Kerbrat P, Desmoulins I, Roca L, Levy C, Lortholary A, Marre A, Delva R, Rios M, Viens P, Brain É, Serin D, Edel M, Debled M, Campone M, Mourret-Reynier MA, Bachelot T, Foucher-Goudier MJ, Asselain B, Lemonnier J, Martin AL, Roché H. Optimal duration of adjuvant chemotherapy for high-risk node-negative (N-) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106). Eur J Cancer. 2017 Jul;79:166-175. doi: 10.1016/j.ejca.2017.03.004. Epub 2017 May 11.

location_facility: Polyclinique Du Parc Centre Maurice Tubiana

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

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

location_facility: Centre Hospitalier General Andre Boulloche

location_facility: Centre Hospital General Robert Ballanger


title: Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

ReferenceCitation: Mancini J, Genre D, Dalenc F, Maylevin F, Martin AL, Viens P, Julian-Reynier C. Transparency in the presentation of trial results may not increase patients' trust in medical researchers. Clin Trials. 2012 Feb;9(1):90-3. doi: 10.1177/1740774511427063. Epub 2011 Nov 2.

ReferenceCitation: Roché H, Allouache D, Romieu G, et al.: Five-year analysis of the FNCLCC-PACS04 trial: FEC100 vs ED75 for the adjuvant treatment of node positive breast cancer. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-602, 2009.

ReferenceCitation: Spielmann M, Roché H, Delozier T, Canon JL, Romieu G, Bourgeois H, Extra JM, Serin D, Kerbrat P, Machiels JP, Lortholary A, Orfeuvre H, Campone M, Hardy-Bessard AC, Coudert B, Maerevoet M, Piot G, Kramar A, Martin AL, Penault-Llorca F. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 2009 Dec 20;27(36):6129-34. doi: 10.1200/JCO.2009.23.0946. Epub 2009 Nov 16.

ReferenceCitation: Spielmann M, Roché H, Humblet Y, et al.: 3-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. [Abstract] Breast Cancer Res Treat 106 (1): A-72, S19, 2007.

ReferenceCitation: Spielmann M, Roché H, Delozier T, et al.: Safety analysis from PACS 04--a phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+patients: preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-632, 2006.

ReferenceCitation: O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors ≤ 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.

location_facility: Centre Hospitalier Regional Metz Thionville

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


title: Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery

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 giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.

status: Terminated

intervention_type: Procedure


ipd_sharing: Yes

status: Active, not recruiting

acronym: DOR/ISL in heavily treatment-experienced participants

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

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

type: EudraCT Number

source: euctr

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

location_facility: Pusan National University Hospital ( Site 5503)

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

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

location_facility: Regional Clinical Infectious Hospital ( Site 5614)

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

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

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

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

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

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)

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

location_facility: IRCCS Policlinico San Matteo ( Site 5010)

location_facility: Holdsworth House Medical Practice ( Site 5300)

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

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

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

location_facility: Infectious Clinical Hospital #2 ( Site 5114)

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

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

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

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

location_facility: Azienda Ospedaliera San Paolo ( Site 5003)

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

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

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

location_facility: Ottawa Hospital Research Institute ( Site 4111)

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

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

location_facility: Medizinische Hochschule Hannover ( Site 4612)

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

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

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

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

location_facility: Wits Clinical HIV Research Unit ( Site 4804)

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

location_facility: Centre Hospitalier de Tourcoing ( Site 4700)

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

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

location_facility: Kyiv City Clinical Hospital 5 ( Site 5616)

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

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

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

location_facility: Ospedale San Gerardo ASST Monza ( Site 5012)

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

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

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

location_facility: Universitaetsklinikum Essen ( Site 4607)

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

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

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

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

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

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

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

location_facility: Georgetown University Hospital ( Site 4015)

location_facility: Centro Cardiovascular Cardiosur ( Site 4407)

location_facility: Hospital Universitario La Paz ( Site 5604)

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

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

location_facility: Chatham County Health Department ( Site 4029)

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

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

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

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

location_facility: Hospital Clinic i Provincial ( Site 5601)

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

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

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

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

location_facility: Hospital Geral de Santo Antonio ( Site 4908)

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


acronym: CARDINAL

title: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome

lead_sponsor: Reata Pharmaceuticals, Inc.

ReferenceCitation: Chertow GM, Appel GB, Andreoli S, Bangalore S, Block GA, Chapman AB, Chin MP, Gibson KL, Goldsberry A, Iijima K, Inker LA, Knebelmann B, Mariani LH, Meyer CJ, Nozu K, O'Grady M, Silva AL, Stenvinkel P, Torra R, Warady BA, Pergola PE. Study Design and Baseline Characteristics of the CARDINAL Trial: A Phase 3 Study of Bardoxolone Methyl in Patients with Alport Syndrome. Am J Nephrol. 2021;52(3):180-189. doi: 10.1159/000513777. Epub 2021 Mar 31.

ReferenceCitation: Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults-an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-719. doi: 10.1007/s00467-020-04819-6. Epub 2020 Nov 6. Review. Erratum in: Pediatr Nephrol. 2021 Jan 12;:.

location_country:
Spain
United Kingdom
Australia
Puerto Rico
United States
France
Japan
Germany

location_facility: University of Pittsburgh School of Medicine - Division of Pediatric Nephrology

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: University Children's Hospital Heidelberg

location_facility: Washington University School of Medicine

location_facility: The Warren Alpert Medical School of Brown University

location_facility: Emory University School of Medicine and Children's Healthcare of Atlanta

location_facility: Arizona Kidney Disease and Hypertension Research Services, PLLC

location_facility: Children's Research Institute - The Children's Mercy Hospital

location_facility: Puerto Rico Clinical & Translational Research Center

location_facility: University of California San Francisco - Children's Renal Center

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Brookview Hills Research Associates, PLLC

location_facility: Hopital Necker-Universite Paris Descartes

location_facility: General Clinical Research Center - Parnassus

location_facility: South Carolina Nephrology & Hypertension Center, Inc

location_facility: Children's Hospital of Philadelphia (CHOP)

location_facility: University of Minnesota - Division of Pediatric Nephrology

summary: This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.


acronym: MARCH-PFIC

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

lead_sponsor: Mirum Pharmaceuticals, Inc.

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

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

location_facility: Michigan Medicine (University of Michigan)

location_facility: Columbia University, Irving Medical Center

location_facility: University of Texas, Health Science Center San Antonio

location_facility: University of Alberta, Edmonton Clinic Health Academy

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

location_facility: Consultario de Joshue David Covarrubias Esquer

location_facility: Hospital Papa Giovanni XXIII / Unità di Pediatria

location_facility: VUMC (Vanderbilt University School of Medicine)

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

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

location_facility: University of Texas Southwestern Medical Center

location_facility: Instytut Pomnik Centrum, Zdrowia Dziecka

location_facility: Koc University Research Center for Translational Medicine (KUTTAM)

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


acronym: APHINITY

title: A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

ReferenceCitation: Gelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M; APHINITY Steering Committee and Investigators. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Epub 2022 Mar 18.

ReferenceCitation: Bines J, Clark E, Barton C, Restuccia E, Procter M, Sonnenblick A, Fumagalli D, Parlier D, Arahmani A, Baselga J, Viale G, Reaby LL, Frank E, Gelber RD, Piccart M, Jackisch C, Petersen JA. Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 Jul;125(1):38-47. doi: 10.1038/s41416-021-01323-y. Epub 2021 Apr 7.

ReferenceCitation: Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pieńkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4.

ReferenceCitation: Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.

ReferenceCitation: Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808.

ReferenceCitation: Kirschbrown WP, Kågedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11.

ReferenceCitation: von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5. Erratum in: N Engl J Med. 2017 Aug 17;377(7):702. Erratum in: N Engl J Med. 2018 Oct 18;379(16):1585.

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
El Salvador
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Panama
Mexico
Sweden
Canada
Switzerland
Guatemala
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Ireland
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Städtische Kliniken Frankfurt am Main Höchst

location_facility: Washington University School of Medicine

location_facility: Emergency University Bucharest Hospital; Oncology Department

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Veterans Memorial Medical Ctr; Cancer Research Centre

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

location_facility: Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Mater Misericordiae Hospital; Chemotherapy Cottage

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: University Of Santo Tomas; Oncology; Benavides Cancer Institute

location_facility: Harbin Medical University Cancer Hospital

location_facility: Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica I

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

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

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Lkh Vöcklabruck; I. Abt. Für Innere Medizin

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

location_facility: Kyunghee University Hospital; Endocrinology

location_facility: Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Florida Cancer Specialists; Saint Petersburg

location_facility: The 900th Hospital of PLA joint service support force

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Cancer Care Centers of South Texas-HOAST - San Antonio

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Hospital General de México; Unidad de Oncologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Seoul National University Bundang Hospital

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Eastern Ct Hema/Onco Assoc; Dept of Oncology

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Texas Oncology-El Paso Cancer Treatment Center Grandview

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: Osaka International Cancer Institute; Breast and Endocrine Surgery

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: National Cancer Center Hospital; Medical Oncology

location_facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

location_facility: Westmead Hospital; Medical Oncology and Pallative Care

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: Luzerner Kantonsspital; Medizinische Onkologie

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Beth Israel Deac Med Ctr; East Campus Rsch Pharmacy

location_facility: RoMed Klinikum Rosenheim; Klinik für Gynäkologie und Geburtshilfe

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

location_facility: Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine

location_facility: Ospedale S. Croce Di Fano; Servizio Oncologia

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Sourasky / Ichilov Hospital; Oncology Department

location_facility: Institut d'oncologie de l'Orangerie; Chimiotherapie

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Uni Hospital Split; Oncology & Radiotherapy

location_facility: Tokai University Hospital, Breast Surgery

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Western General Hospital; Edinburgh Breast Unit

location_facility: Geelong Hospital; Andrew Love Cancer Centre

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

location_facility: Petz Aladar Megyei Oktato Korhaz; Oncoradiologia

location_facility: Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer

location_facility: Hôpitaux Universit. de Genève Gynécologique - Oncologie; Gynécologie

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Policlinico di Monza; Istituto di Oncologia

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: US oncology research at Minnesota Oncology

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

location_facility: Saitama Medical University International Medical Center; Breast Oncology

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

location_facility: Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

location_facility: Galway University Hospital; Clinical Trials Department

location_facility: Lismore Base Hospital; Cancer Care & Haematology Unit

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: South Carolina Oncology Associates - SCRI

location_facility: Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica

location_facility: Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

location_facility: Evangelisches Krankenhaus; Abt. Gynäkologie und Geburtshilfe

location_facility: Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Sir Charles Gairdner Hospital; Medical Oncology

location_facility: Northeastern Ontario; Regional Cancer Centre

location_facility: Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: Kumamoto Shinto General Hospital; Breast Cancer Center

location_facility: NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Skłodowskiej-Curie

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik

location_facility: DONAU ISAR Klinikum Deggendorf; Frauenklinik

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: St. Bartholomew'S Hospital; Dept of Medical Oncology

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Lopburi Cancer Hospital; Chemotherpy Unit; Chemotherapy

location_facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Centro Regional de Enfermedades Oncológicas, S.A.

location_facility: Royal Berkshire Hospital; Berkshire Cancer Centre

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Albert Einstein Healthcare Network ; Cancer Center

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Karolinska University Hospital; Department of General Oncology

location_facility: Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Fujian Medical University Union Hospital

location_facility: Chiba Cancer Center; Breast Surgical Oncology

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Sankt Elisabeth Krankenhaus; Gynaekology

location_facility: Isis Centro Especializado de Luces; Oncology

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: A. Ö. Krankenhaus Der Barmherzigen Brüder; Interne Abt.

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: Cancer Center of Acadiana at Lafayette General

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: University of North Carolina-Chapel Hill

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Northwest Cancer Specialists - Portland (NE Hoyt St)

location_facility: Inst. Nacional de Cancerologia; Clinica de Seno

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Mount Sinai Beth Israel Comprehensive Cancer Center

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: Taichung Veterans General Hospital; Dept of Surgery

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

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

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Cancer Centers of the Carolina; Eastside Medical Center

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Chiang Rai Prachanukraw Hospital; Department of Pediatrics, Faculty of Medicine

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Wesley Medical Centre; Clinic For Haematology and Oncology

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center.

location_facility: Sydvestjysk Sygehus Esbjerg; Onkologisk afdeling

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Atlantic Health Science Corporation; Saint John Regional Hospital Facility

location_facility: St. Josefs-Hospital Wiesbaden GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Hiroshima City Hiroshima Citizens Hospital; Breast Surgery

location_facility: Heartland CCOP/Missouri Baptist Medical Center

location_facility: Centro Estatal De Cancerologia De Durango; Oncology

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Changhua Christian Hospital; Dept of Surgery

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

location_facility: Hospital Angeles Metropolitano; Room 220

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Waikato Hospital; Dept of Medical Oncology

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: University of Missouri-Columbia; Ellis Fischel Cancer Center

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Queen Alexandra Hospital; Haematology and Oncology Centre

location_facility: Cheltenham General Hospital; Gloucestershire Oncology Centre

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: University Hospital coventry; Oncology Department

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology

location_facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Vanderbilt Breast Center at One Hundred Oaks

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Tokyo Metropolitan; Komagome Hospital, Surgery

location_facility: Florida Cancer Specialists, Research Department

location_facility: UMHAT Tsaritsa Yoanna - ISUL; Clinic of Oncotherapy

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Dana Farber Cancer Institute at Faulkner Hospital

location_facility: Lvov State Regional Oncology Medical & Diagnostic Center

location_facility: Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).


title: A Phase II Prospective Study "GFM-DACORAL-DLI" ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients

summary: Study of early administration of ASTX727 associated with late Donor Lymphocyte Infusions after allogenic stem cell transplantation in very high risk MDS or AML patients

lead_sponsor: Groupe Francophone des Myelodysplasies

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

location_facility: Hôpital Pitié-Salpêtrière - Service hématologie clinique

location_facility: IUCT Oncopole - Département d'hématologie - Service de greffe de cellules souches hématopoïétiques

location_facility: Institut de Cancérologie Lucien Neuwirth - Hématologie clinique et thérapie cellulaire

location_facility: CHU de Grenoble - Clinique Universitaire d'hématologie

location_facility: Hôpital Saint Eloi - Service hématologie clinique

location_facility: Hôpital Saint Louis - Service hématologie-greffe

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

location_facility: CHU Brabois - Service hématologie clinique

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

location_facility: Centre Henri Becquerel - Département d'hématologie

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

location_facility: CHU Hôtel Dieu - Service hématologie clinique

location_facility: CHU Estaing - Service hématologie clinique et thérapie cellulaire

location_facility: Hôpital Necker - Service hématologie adulte


title: Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial

acronym: LapCHC

summary:
Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.

Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse

location_facility: Chirurgie viscérale et digestive - CHU Rouen

location_facility: Chirurgie Digestive et Transplantations - Hôpital Huriez

location_facility: Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse

location_facility: Chirurgie hépato-biliaire et greffe de foie - La Pitié

location_facility: Chirurgie digestive - Institut Mutualiste Montsouris

location_facility: Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil

location_facility: Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours

location_facility: Chirurgie Digestive et de l'Urgence - CHU Grenoble

location_facility: Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor

location_facility: Chirurgie viscérale et digestive - CHU Besançon


acronym: STHENOS

title: Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS

lead_sponsor: Novartis Pharmaceuticals

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
United Kingdom
Spain
Italy
France
Germany

summary: This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients


title: Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

acronym: Hemo-FAST

summary: The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.

time_perspective: Cross-Sectional

lead_sponsor: Swedish Orphan Biovitrum

intervention_type: Diagnostic Test


title: Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF

acronym: PREEMPT-HF

summary:
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study.

Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

ReferenceCitation: Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

ReferenceCitation: Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.

ReferenceCitation: Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041. Review.

ReferenceCitation: Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.

ReferenceCitation: Whellan DJ, Lindenfeld J. Easy to Predict, Difficult to Prevent. JACC Heart Fail. 2017 Mar;5(3):226-228. doi: 10.1016/j.jchf.2017.01.006.

ReferenceCitation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735.

ReferenceCitation: Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA. 2017 Jul 18;318(3):270-278. doi: 10.1001/jama.2017.8444.

ReferenceCitation: Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.

ipd_sharing: Undecided

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Hong Kong
Spain
Ireland
Italy
Australia
Netherlands
Canada
United Kingdom
United States
France
Belgium
Germany

location_facility: South Manchester University Hospital Trust

location_facility: Strong Memorial Hospital of the University of Rochester

location_facility: Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie

location_facility: St. Francis Health System - St. Francis Hospital

location_facility: Providence Regional Medical Center Everett

location_facility: Christus Trinity Mother Frances Health System

location_facility: The University of Texas, Southwestern Medical Center

location_facility: Baptist Health Medical Center (Little Rock)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Cardiology Associates of Northeast Arkansas

intervention_type: Device


title: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study

acronym: RESEDAE

summary: This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes

location_facility: Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes


title: A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

summary: To evaluate the efficacy and safety of eplontersen after administration for 65 weeks to patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), as compared to the NEURO-TTR trial (NCT01737398). For more information, please visit http://www.neuro-ttransform.com/.

ReferenceCitation: Coelho T, Ando Y, Benson MD, Berk JL, Waddington-Cruz M, Dyck PJ, Gillmore JD, Khella SL, Litchy WJ, Obici L, Monteiro C, Tai LJ, Viney NJ, Buchele G, Brambatti M, Jung SW, St L O'Dea L, Tsimikas S, Schneider E, Geary RS, Monia BP, Gertz M. Design and Rationale of the Global Phase 3 NEURO-TTRansform Study of Antisense Oligonucleotide AKCEA-TTR-L(Rx) (ION-682884-CS3) in Hereditary Transthyretin-Mediated Amyloid Polyneuropathy. Neurol Ther. 2021 Jun;10(1):375-389. doi: 10.1007/s40120-021-00235-6. Epub 2021 Feb 26.

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Taiwan
Brazil
Portugal
Spain
Greece
Italy
Australia
New Zealand
Argentina
Canada
Sweden
United States
France
Turkey
Germany
Cyprus

location_facility: Indiana University School of Medicine - Indianapolis

location_facility: Associação de Assistência à Criança Deficiente - Unidade Lar Escola

location_facility: Hospital Universitário Clementino Fraga Filho

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: The Cyprus Institute of Neurology and Genetics

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: İstanbul Üniversitesi - Istanbul Tıp Fakültesi

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Johns Hopkins University Neurology Research Office

location_facility: University of North Carolina Hospitals - Neurology Clinic

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

location_facility: University General Hospital of Heraklion (PAGNI)

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta


title: A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

lead_sponsor: AbbVie

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 and 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.

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
Hungary
Korea, Republic of
United States
France
Germany

location_facility: Kyungpook National University Hospital /ID# 209912

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549

location_facility: Orange County Institute of Gastroenterology and Endoscopy /ID# 207405

location_facility: Banner University Medical Cent /ID# 208392

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 208133

location_facility: Vanderbilt University Medical Center /ID# 204670

location_facility: Meridian Investigator Network /ID# 204646

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 208131

location_facility: Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221952

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 204689

location_facility: Yeungnam University Medical Center /ID# 210447

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570

location_facility: Franciscus Gasthuis & Vlietland /ID# 206976

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 206272

location_facility: Hospital General Universitario Gregorio Maranon /ID# 204504

location_facility: Belfast Health and Social Care Trust /ID# 206744

location_facility: Universitaetsklinikum Frankfurt /ID# 207569

location_facility: Meridian Investigator Network /ID# 218568

location_facility: NHS Greater Glasgow and Clyde /ID# 206574

location_facility: Hospital Santa Creu i Sant Pau /ID# 213259

location_facility: Hospital Universitario La Paz /ID# 210065

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576

location_facility: Penn Presbyterian Medical Center /ID# 206826

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571

location_facility: Maastricht Universitair Medisch Centrum /ID# 204428

summary: Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.


title: Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)

acronym: SINNO-RA

summary:
Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population.

First-line treatment with immunomodulators (synthetic and biological Disease Modifying Anti-Rheumatic Drugs (sDMARDs) including methotrexate) is not sufficiently effective in 40% of cases. These patients are then treated with biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) called biotherapies. As the use of these bio-drugs increases each year, they become a major public health and economic issue. Their growth is only just beginning, as they are among the major providers of pharmaceutical innovation.

There are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 000 euros per patient. This cost is 20 times higher than that of sDMARDs. However, among patients treated with biotherapy, clinical practice shows that approximately one-third (33%) will not respond to the selected bio-drugs.

In the event of non-response, physicians currently have no choice but to rotate empirically between different treatments, as no tools capable of predicting response or non-response to these molecules are currently available. SinnoTest® software, a predictive algorithm for responding to bDMARDs by analyzing proteomic biomarkers, will clarify this choice of prescription for patients with failed RA of a first bDMARD in the anti-TNF family.

status: Withdrawn

primary_purpose: Supportive Care

ReferenceCitation: Nguyen MVC, Baillet A, Romand X, Trocmé C, Courtier A, Marotte H, Thomas T, Soubrier M, Miossec P, Tébib J, Grange L, Toussaint B, Lequerré T, Vittecoq O, Gaudin P. Prealbumin, platelet factor 4 and S100A12 combination at baseline predicts good response to TNF alpha inhibitors in rheumatoid arthritis. Joint Bone Spine. 2019 Mar;86(2):195-201. doi: 10.1016/j.jbspin.2018.05.006. Epub 2018 Jun 6.

ReferenceCitation: Nguyen MVC, Adrait A, Baillet A, Trocmé C, Gottenberg JE, Gaudin P. Identification of cartilage oligomeric matrix protein as biomarker predicting abatacept response in rheumatoid arthritis patients with insufficient response to a first anti-TNFα treatment. Joint Bone Spine. 2019 May;86(3):401-403. doi: 10.1016/j.jbspin.2018.09.005. Epub 2018 Sep 19.

ReferenceCitation: Baillet A, Trocmé C, Romand X, Nguyen CMV, Courtier A, Toussaint B, Gaudin P, Epaulard O. Calprotectin discriminates septic arthritis from pseudogout and rheumatoid arthritis. Rheumatology (Oxford). 2019 Sep 1;58(9):1644-1648. doi: 10.1093/rheumatology/kez098.

ReferenceCitation: Baillet A, Trocmé C, Berthier S, Arlotto M, Grange L, Chenau J, Quétant S, Sève M, Berger F, Juvin R, Morel F, Gaudin P. Synovial fluid proteomic fingerprint: S100A8, S100A9 and S100A12 proteins discriminate rheumatoid arthritis from other inflammatory joint diseases. Rheumatology (Oxford). 2010 Apr;49(4):671-82. doi: 10.1093/rheumatology/kep452. Epub 2010 Jan 25.

ReferenceCitation: Trocmé C, Marotte H, Baillet A, Pallot-Prades B, Garin J, Grange L, Miossec P, Tebib J, Berger F, Nissen MJ, Juvin R, Morel F, Gaudin P. Apolipoprotein A-I and platelet factor 4 are biomarkers for infliximab response in rheumatoid arthritis. Ann Rheum Dis. 2009 Aug;68(8):1328-33. doi: 10.1136/ard.2008.093153. Epub 2008 Jul 29.

lead_sponsor: University Hospital, Grenoble

location_facility: Groupe Hospitalier Pellegrin - CHU de Bordeaux

location_facility: APHP Groupe hospitalier Pitié-Salpêtrière


title: SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR: OPTIMIZATION OF THE PROCEDURE BY REPOSITIONING THE ELECTRODES AND RESEARCH OF THE PREDICTIVE FACTORS OF FAILURE

acronym: SIS

summary: S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

primary_purpose: Other

lead_sponsor: Centre Hospitalier de PAU

location_facility:
APHP - Pitié Salpêtrière
CHU de Caen
Hopitl Cardiologique Louis Pradel
AP-HP Hôpital européen Georges-Pompidou
CH de Pau
CHU de Nantes
Hopital Saint Philivert
CHU de Tours
CHRU de BREST
CHRU de Strasbourg
CHU de Limoges
CHU deToulouse
CHRU de Lille
Clinique Pasteur
CHU de Nancy
CHU de Rennes


title: CLARIFY: Autosomal Dominant Hypocalcemia Types 1 And 2 (ADH1/2) Disease Monitoring Study (DMS)

summary: A global, multi-center, non-interventional Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

time_perspective: Other

lead_sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company

location_country:
Italy
Australia
Canada
United States
France
Belgium

location_facility: Departement d'Endocrinologie et Diabetes pour Enfants - AP-HP Hopital Bicetre

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: Ohio State University Medical Center (OSUMC)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: The Diabetes & Thyroid Center of Fort Worth (DTC)

location_facility: Indiana University (IU) School of Medicine - University Hospital


title: Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy

acronym: RIGHTCOLOCALCI

summary:
Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.

A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.

The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Clinique Mutualiste de la Porte de l'Orient


acronym: PROGRESSION

title: Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial

location_facility: APHP - Hôpital Xavier Bichat-Claude Bernard

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: CHU de Caen - Hôpital de la Côte de Nacre

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

summary:
Idiopathic pulmonary fibrosis (IPF) is a prototype of chronic, progressive, and fibrotic lung disease. It has been considered rare, with an incidence estimated to 11.5 cases per 100 000 individuals per year. Increasing rates of hospital admissions and deaths due to IPF suggest an increasing burden of disease. The median survival time from diagnosis is 2-4 years.

Recently two disease-modifying therapies, pirfenidone and nintedanib, have been approved worldwide. Both drugs reduce the disease progression as measured by progressive decline in forced vital capacity (FVC), with a reduction of overall mortality showed by meta-analysis of phase III pirfenidone trials.

However, progression of disease continues to occur despite the currently available drug therapy. Many patients die from progressive, chronic hypoxemic respiratory failure, or less frequently from acute exacerbation of pulmonary fibrosis. In these patients, no data are available to guide management between continuation of the prescribed antifibrotic drug, to switch to the other available antifibrotic drug, or to combine the available drugs.

The combination of nintedanib and pirfenidone is not recommended outside clinical trials. However, although both antifibrotic drugs were developed and approved as monotherapy, two recent trials have suggested the feasibility and safety of combining them over a 12-24 weeks period. These results encourage further studies of combination treatment with pirfenidone and nintedanib in patients with IPF. Such study is timely, as there is a risk that clinicians facing the continued worsening of disease in patients receiving one of the available drugs may prescribe both drugs combined outside clinical trials, potentially exposing patients to a currently unknown risk.

This study will evaluate the efficacy and tolerance of the combination pirfenidone and nintedanib as compared to a "switch monotherapy": i.e. switching from the current to the other of the two existing drugs prescribed as monotherapy, in patients who present chronic worsening IPF despite receiving either pirfenidone or nintedanib and as to a "control group": i.e.treatment still be on as before randomization (pirfenidone or nintedanib).


title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Italy
Russian Federation
Canada
Guatemala
Korea, Republic of
United States
France
Mexico

location_facility: 1218.56.82005 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.33003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.50203 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.39005 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.01004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.11001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.50202 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.33006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.01006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70003 Boehringer Ingelheim Investigational Site

summary:
The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.