title: An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)

summary: This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

ReferenceCitation: Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Thailand
Canada
France
Portugal
Hungary
Hong Kong
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Greece
Panama
South Africa
Taiwan
Russian Federation
Israel

location_facility: Dunedin Hospital; Oncology - Haematology Clinical Practice Group

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Hospital de Baleia; Serviço de Oncologia Clínica

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

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

location_facility: Overlook Oncology Center; Summit Medical Group

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Mercy Uni Hospital; Deparment of Medical Oncology

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Isthmian Medical Research Center, S.A.; Oncology

location_facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

location_facility: Innovative clinical research institute/American institute of research

location_facility: Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology

location_facility: University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

location_facility: St. Vincent'S Hospital; Comprehensive Care Center

location_facility: Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

location_facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

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

location_facility: Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Oncology-Hematology of Lehigh Valley, Pc

location_facility: Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr

location_facility: N.N.Burdenko Main Military Clinical Hospital; Chemotherapy

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Hospital das Clinicas - FMUSP; Gastroenterologia

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

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

location_facility: Uni of Pittsburgh Cancer Inst. ; Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

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

location_facility: Per. Gen. Hospital Ippokrateion; Oncology Dept.

location_facility: Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology

location_facility: Dr. H. Bliss Murphy Cancer Centre; Oncology

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Presbyterian Healthcare; Cancer Research Dept

location_facility: St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)

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

location_facility: Georgetown Uni Medical Center; Lombardi Cancer Center

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Little Company of Mary Hospital; Mary Potter Oncology Centre

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

location_facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

location_facility: Internal Medicine Associates of Yakima Inc.

location_facility: Sourasky / Ichilov Hospital; Oncology Department

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery

location_facility: Royal Marsden Nhs Trust; Consultant Cancer Physician

location_facility: Wellington Hospital; Regional Oncology Unit

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University Hospital of Patras Medical Oncology

location_facility: Theagenio Anticancer Hospital; 3Rd Oncology Clinic

location_facility: New Mexico Oncology Hematology Consultants

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: West Suffolk Hospital Nhs Trust; Gi Corridor

location_facility: West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Ospedale Cervesi di Cattolica; ONCOLOGIA

location_facility: Morristown Medical Center;Hematology-Oncology Assoc

location_facility: St John of God Hospital; Medical Oncology

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego

location_facility: Southern Medical Day Care; Clinical Trials Unit

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

location_facility: Derbyshire Royal Infirmary; Dept of Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology

location_facility: Hammersmith Hospital; Mrc Clinical Science Centre

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica

location_facility: Hospital Universitario de la Princesa; Servicio de Oncologia

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: Kaiser Permanente San Diego; Hepatology Research

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery

location_facility: Bumrungrad Hospital Foundation; Horizon Centre

location_facility: Hematology-Oncology Centers of the Northern Rockies

location_facility: Northern Centre for Cancer Care;Oncology

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Srinagarind Hospital; Medical Oncology Unit

location_facility: The Royal Sussex County Hospital; the Sussex Cancer Centre

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii

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

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Salisbury District General Hospital; Medical Oncology Dept

location_facility: Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

location_facility: Hopital Du Sacre Coeur de Montreal; Pneumologie

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

location_facility: Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology

location_facility: The Second Affiliated Hospital of Zhejiang University College

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Theageneio Anticancer Hospital; Gastroenterology

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Ospedale Degli Infermi; Divisione Di Oncologia

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow

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

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

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Queen Elizabeth Hospital; Medical Oncology


title: A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

acronym: EFECT

summary: The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: AstraZeneca

location_country:
Germany
Hungary
Argentina
Denmark
Israel
Brazil
Sweden
United Kingdom
Belgium
United States
Spain
South Africa
Canada
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma

summary: The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Bristol-Myers Squibb

location_country:
Finland
France
Germany
Italy
Portugal
Slovakia
Norway
Hong Kong
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Czech Republic


title: The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism

summary:
Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.

ReferenceType: derived

ReferenceCitation: Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.

ReferenceCitation: van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104. doi: 10.1056/NEJMoa064247.

lead_sponsor: Sanofi

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Sweden

location_facility: Lovelace Health Systems, Clinical Thrombosis Center

location_facility: Hamilton Health Sciences - General Hospital

location_facility: Pulmonary Associates of Fredericksburg, Inc.

location_facility: University Health Network, Toronto General Hospital

location_facility: University of California, San Diego Medical Center

location_facility: Scott & White Memorial Hospital & Clinic

location_facility: Loyola University Medical Center and Outpatient Clinic

location_facility: The University of Texas Health Center at Tyler


title: A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

summary: This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.

lead_sponsor: Pfizer

location_country:
Germany
Italy
United States
Spain
South Africa
France


title: Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

lead_sponsor: Eisai Inc.

location_country:
Poland
Hungary
Israel
United Kingdom
Australia
United States
Greece
Canada
Czech Republic
Russian Federation
France

location_facility: Centre Hospitalier Intercommunal de la Haute-Saone

location_facility: Klinika pneumologie a hrudni chirurgie 3.LF

location_facility: Koranyi National Institute for Pulmonology

location_facility: Semmelweis University Department of Pulmonology

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: Wielkopolskie Centrum Chorob Pluc I Gruzlicy

location_facility: 6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest

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

location_facility: University Oncology & Hematology Associates

location_facility: Desert Hematology-Oncology Medical Group, Inc.

location_facility: 7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest

location_facility: Research Institute of Oncology n.a. Petrov

location_facility: Research Institute of Oncology n.a. Hertzen

location_facility: 1st Pulmonary Clinic of G. Papanikolaou Hospital

location_facility: Louisiana State University Health Science Center

location_facility: University General Hospital of Heraklion

location_facility: Russian Oncology Research Center n.a. Blokhin

location_facility: 2nd Pulmonary Clinic of G. Papanikolaou Hospital

location_facility: Fovarosi Onkormanyzat Uzsoki utcai, Korhaza

location_facility: St. Petersburg Pavlov State Medical University


summary: The purpose of this study is to determine if patients who take YM598 in addition to mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated with prostate cancer metastases in the bone.

status: Terminated

lead_sponsor: Astellas Pharma Inc

sponsor_collaborators:
Astellas Pharma Inc
Astellas Pharma US, Inc.

location_country:
Germany
Ireland
Poland
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
France

location_facility: Clinical Research Centre, St George's Hospital, Urology Division

location_facility: Cliniques Universitaires St-Luc, Service d'Urologie

location_facility: Instituto Valenciano de Oncologia, Servicio de Oncologia

location_facility: Hospital Universitario de Getafe, Servicio de Urologia, Crta

location_facility: Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow

location_facility: University of Chicago, Section of Hematology/Oncology

location_facility: Queen Elizabeth Hospital, Clinical Hematology & Oncology

location_facility: Hospital General Vall d'Hebron, Servicio de Oncología

location_facility: Department of Clinical Oncology, Royal North Shore Hospital

location_facility: University of Illinois, Department of Urology

location_facility: Department of Medical Oncology, The Canberra Hospital

location_facility: Department of Urological Research, Derriford Hospital

location_facility: Department of Medical Oncology, Newcastle Mater Hospital

location_facility: Hospital Universitario Príncipe de Asturias, Servicio de Urología

location_facility: Department of Urology, St Bartholomew's Hospital

location_facility: Washington University School of Medicine

location_facility: Division of Oncology Ward, Royal Brisbane Hospital

location_facility: Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot

location_facility: Hospital Clinic i Provincial, Servicio de Oncologia

location_facility: Imperial College School of Medicine, Dept Cancer Medicine

location_facility: Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie

location_facility: Krankenhause am Urban, Urologie Dieffenfachstr

location_facility: Department of Urology, East Surrey Hospital

location_facility: Service d'Urologie, Hôpital Henri Mondor

location_facility: Department of Medical Oncology, Concord Hospital Medical Centre

location_facility: Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie

location_facility: Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie

location_facility: Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii

status_simplified: Unknown


title: A Phase II, Randomized, Partially-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of 12 Weeks of Treatment with Clevudine (10 mg, 30 mg or 50 mg QD) in Patients Infected with Hepatitis B Virus.

summary: The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.

status: Unknown status

lead_sponsor: Triangle Pharmaceuticals

location_country:
Singapore
United States
China
Canada
France

location_facility: Prince of Wales Hospital, Department of Medicine and Therapeutics

location_facility: National University Hospital, Division of Gastroenterology, Department of Medicine

location_facility: Hospital Dieu, Service Hepatogastroenterologie-endoscopie

location_facility: The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital

location_facility: Thomas Jefferson University Hospital, Jefferson Medical College

location_facility: Hospital St Louis, Service de Medecine Interne

location_facility: Hospital Beaujon, Service Hepatologie Centre Pierre Abrami

location_facility: Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie

location_facility: University of British Columbia, Downtown Infectious Disease Clinic


title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.

summary: This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Poland
New Zealand
Brazil
Costa Rica
Chile
Canada
France
Czech Republic
Lithuania
Slovakia
Hungary
United States
Honduras
Belgium
China
Estonia
Puerto Rico
Italy
Jamaica
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Bulgaria
Russian Federation


title: CLOCC Trial (Chemotherapy + Local Ablation Versus Chemotherapy) Randomized Phase II Study Of Local Treatment Of Liver Metastases By Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone In Patients With Unresectable Colorectal Liver Metastases

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 bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases.

PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer.

ReferenceType: result

ReferenceCitation: Ruers T, van Coevorden F, Pierie J, et al.: Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): interim results of a randomised phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC). [Abstract] J Clin Oncol 26 (Suppl 15): A-9535, 2008.

ReferenceCitation: Ruers T, Punt C, Van Coevorden F, Pierie JPEN, Borel-Rinkes I, Ledermann JA, Poston G, Bechstein W, Lentz MA, Mauer M, Van Cutsem E, Lutz MP, Nordlinger B; EORTC Gastro-Intestinal Tract Cancer Group; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO) and the National Cancer Research Institute Colorectal Clinical Study Group (NCRI CCSG). Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004). Ann Oncol. 2012 Oct;23(10):2619-2626. doi: 10.1093/annonc/mds053. Epub 2012 Mar 19.

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

collaborators: Arbeitsgruppe Lebermetastasen und Tumoren

collaborators: Institute of Cancer Research, United Kingdom

location_country:
Germany
Italy
Hungary
United Kingdom
Sweden
Netherlands
Austria
Belgium
Egypt
France

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Azienda Ospedaliera S. Camillo-Forlanini

location_facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Cancer Research UK and University College London Cancer Trials Centre

location_facility: Karolinska University Hospital - Huddinge

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne


title: A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis

summary: A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Hungary
Argentina
Australia
Brazil
Belgium
United States
Korea, Republic of
Taiwan
Canada
Ukraine
Russian Federation
France

location_facility: National Institute for Rheumatology and Physiotherapy

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia

location_facility: Rheumatologie und Physikalische Therapie

location_facility: Università degli Studi di Napoli "Federico II"


title: A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma

summary: Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

ReferenceCitation: Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, Mulders P, Zielinski H, Hoos A, Teofilovici F, Isakov L, Flanigan R, Figlin R, Gupta R, Escudier B; C-100-12 RCC Study Group. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet. 2008 Jul 12;372(9633):145-154. doi: 10.1016/S0140-6736(08)60697-2. Epub 2008 Jul 3.

lead_sponsor: Agenus Inc.

location_country:
Poland
Israel
Norway
United Kingdom
Sweden
Austria
Belgium
United States
Spain
Canada
France


title: A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.

study_start_date_type: Actual

ReferenceCitation: Suh JH, Stea B, Nabid A, Kresl JJ, Fortin A, Mercier JP, Senzer N, Chang EL, Boyd AP, Cagnoni PJ, Shaw E. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. J Clin Oncol. 2006 Jan 1;24(1):106-14. doi: 10.1200/JCO.2004.00.1768. Epub 2005 Nov 28.

ReferenceCitation: Nabid A, Kresl J, Stea B, et al.: Standard whole brain radiation (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: results of a subgroup analysis. [Abstract] J Clin Oncol 22 (Suppl 14): A-7115, 645s, 2004.

ReferenceCitation: Shaw E, Stea B, Pinter T, et al.: Pharmacokinetics (PK) of RSR13 (efaproxiral) predict survival in patients with brain metastases randomized to receive whole brain radiation therapy (WBRT) with or without RSR13 (REACH RT-009). [Abstract] J Clin Oncol 22 (Suppl 14): A-1561, 122s, 2004.

ReferenceCitation: Stea B, Suh J, Shaw E, et al.: Efaproxiral (EFAPROXYN) as an adjunct to whole brain radiation therapy for the treatment of brain metastases originating from breast cancer: updated survival results of the randomized REACH (RT-009) study. [Abstract] Breast Cancer Res Treat 88 (1): A-4064, 2004.

ReferenceCitation: Suh J, Stea BD, Nabid A, et al.: Prognostic factors for survival in patients with brain metastases enrolled on a worldwide phase 3 randomized trial of 538 patients (study RSR13 RT-009). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-60, S165, 2004.

ReferenceCitation: Suh J, Stea B, Nabid A, et al.: Standard whole brain radiation therapy (WBRT) with supplemental oxygen (O2), with or without RSR13 (efaproxiral) in patients with brain metastases: results of the randomized REACH (RT-009) study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1534, 115s, 2004.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
Belgium
United States
Canada
France

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Decatur Memorial Hospital Cancer Care Institute

location_facility: British Columbia Cancer Agency - Fraser Valley Cancer Centre

location_facility: Comprehensive Cancer Center at Wake Forest University

location_facility: Royal Prince Alfred Hospital Medical Center

location_facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)

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

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

location_facility: State University of New York - Upstate Medical University

location_facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

location_facility: Cooper Hospital/University Medical Center

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Comprehensive Cancer Care Specialists of Boca Raton


title: A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

summary:
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

ReferenceType: background

ReferenceCitation: Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.

lead_sponsor: Abbott

location_country:
Germany
Poland
United Kingdom
Denmark
Australia
Brazil
Switzerland
Austria
United States
Spain
South Africa
Canada
Puerto Rico
France

location_facility: Orange County Ctr for Special Immunology

location_facility: East Orange Veterans Administration Med Ctr

location_facility: San Francisco Veterans Administration Med Ctr

location_facility: Groupe Hospitalier Bichat-Claude Bernard

location_facility: Hosp Do Servidor Publico Estadual De Sao Paulo

location_facility: Division of Inf Diseases/ Indiana Univ Hosp

location_facility: Univ of Michigan Hospitals and Health Ctrs

location_facility: Cornell Clinical Trials Unit - Chelsea Clinic

location_facility: SUNY at Stony Brook / Div of Infectious Disease

location_facility: Community Research Initiative of New England

location_facility: Duke Univ Med Ctr / Infectious Disease Clinic

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat

location_facility: Holmes Hosp / Univ of Cincinnati Med Ctr


title: A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

summary: The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

location_facility: Univ of Utah Med School / Clinical Trials Ctr

location_facility: Saint Michael's Med Ctr / Dept of Infectious Diseases

location_facility: SUNY / Health Sciences Ctr at Stony Brook


title: A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.

ReferenceCitation: Chi DS, Musa F, Dao F, Zivanovic O, Sonoda Y, Leitao MM, Levine DA, Gardner GJ, Abu-Rustum NR, Barakat RR. An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT). Gynecol Oncol. 2012 Jan;124(1):10-4. doi: 10.1016/j.ygyno.2011.08.014. Epub 2011 Sep 13.

ReferenceCitation: Verleye L, Ottevanger PB, Kristensen GB, Ehlen T, Johnson N, van der Burg ME, Reed NS, Verheijen RH, Gaarenstroom KN, Mosgaard B, Seoane JM, van der Velden J, Lotocki R, van der Graaf W, Penninckx B, Coens C, Stuart G, Vergote I. Quality of pathology reports for advanced ovarian cancer: are we missing essential information? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial. Eur J Cancer. 2011 Jan;47(1):57-64. doi: 10.1016/j.ejca.2010.08.008. Epub 2010 Sep 16.

ReferenceCitation: Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

ReferenceCitation: Fruehauf JP, Yu I, Parker R: In vitro drug response and biomarker profiles for ovarian cancer specimens obtained at initial debulking or after neoadjuvant chemotherapy (EORTC 55971). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2177, 2002.

ReferenceCitation: Tajik P, van de Vrie R, Zafarmand MH, Coens C, Buist MR, Vergote I, Bossuyt PMM, Kenter GG. The FIGO Stage IVA Versus IVB of Ovarian Cancer: Prognostic Value and Predictive Value for Neoadjuvant Chemotherapy. Int J Gynecol Cancer. 2018 Mar;28(3):453-458. doi: 10.1097/IGC.0000000000001186.

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: publishedVersion

repositories_concat: LIRIAS (KU Leuven)

unpaywall_oa_status: green

publisher_dissemination: British Medical Journal

ReferenceCitation: Vizzielli G, Fanfani F, Chiantera V, Tortorella L, Lucidi A, Petrillo M, Costantini B, Scambia G, Fagotti A. Does the diagnosis center influence the prognosis of ovarian cancer patients submitted to neoadjuvant chemotherapy? Anticancer Res. 2015 May;35(5):3027-32.

ReferenceCitation: van Meurs HS, Tajik P, Hof MH, Vergote I, Kenter GG, Mol BW, Buist MR, Bossuyt PM. Which patients benefit most from primary surgery or neoadjuvant chemotherapy in stage IIIC or IV ovarian cancer? An exploratory analysis of the European Organisation for Research and Treatment of Cancer 55971 randomised trial. Eur J Cancer. 2013 Oct;49(15):3191-201. doi: 10.1016/j.ejca.2013.06.013. Epub 2013 Jul 11.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

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

location_country:
Germany
Ireland
Italy
Portugal
Norway
Argentina
Denmark
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Canada
France

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

location_facility: Karolinska University Hospital - Huddinge

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Hospital de Clinicas "Jose De San Martin"

location_facility: Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: McGill Cancer Centre at McGill University

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Hospital Universitario Central de Asturias

location_facility: Libero Istituto Universitario Campus Bio-Medico

location_facility: Haukeland Hospital - University of Bergen

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano


title: Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration

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 transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.

enrollment_type: Anticipated

ReferenceCitation: de Witte T, Hagemeijer A, Suciu S, Belhabri A, Delforge M, Kobbe G, Selleslag D, Schouten HC, Ferrant A, Biersack H, Amadori S, Muus P, Jansen JH, Hellstrom-Lindberg E, Kovacsovics T, Wijermans P, Ossenkoppele G, Gratwohl A, Marie JP, Willemze R. Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial. Haematologica. 2010 Oct;95(10):1754-61. doi: 10.3324/haematol.2009.019182. Epub 2010 May 21.

location_country:
Germany
Italy
Sweden
Netherlands
Switzerland
Belgium
Croatia
Czech Republic
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Institute of Hematology and Blood Transfusion

location_facility: University Hospital - Rotterdam Dijkzigt


title: A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.

ReferenceCitation: Reman O, Pigneux A, Huguet F, Vey N, Delannoy A, Fegueux N, de Botton S, Stamatoullas A, Tournilhac O, Buzyn A, Charrin C, Boucheix C, Gabert J, Lheritier V, Vernant JP, Fiere D, Dombret H, Thomas X; GET-LALA group. Central nervous system involvement in adult acute lymphoblastic leukemia at diagnosis and/or at first relapse: results from the GET-LALA group. Leuk Res. 2008 Nov;32(11):1741-50. doi: 10.1016/j.leukres.2008.04.011. Epub 2008 May 27.

ReferenceCitation: Tavernier E, Le QH, de Botton S, Dhedin N, Bulabois CE, Reman O, Vey N, Lheritier V, Dombret H, Thomas X. Secondary or concomitant neoplasms among adults diagnosed with acute lymphoblastic leukemia and treated according to the LALA-87 and LALA-94 trials. Cancer. 2007 Dec 15;110(12):2747-55. doi: 10.1002/cncr.23097.

ReferenceCitation: Dhedin N, Dombret H, Thomas X, Lheritier V, Boiron JM, Rigal-Huguet F, Vey N, Kuentz M, Reman O, Witz F, Delannoy A, Kovacsovics T, Bradstock K, Charrin C, Boucheix C, Gabert J, Blaise D, Fiere D, Vernant JP. Autologous stem cell transplantation in adults with acute lymphoblastic leukemia in first complete remission: analysis of the LALA-85, -87 and -94 trials. Leukemia. 2006 Feb;20(2):336-44. doi: 10.1038/sj.leu.2404065.

ReferenceCitation: Picard C, Hayette S, Bilhou-Nabera C, Cayuela JM, Delabesse E, Frenoy N, Preudhomme C, Dupont M, Bastard C, Bories D, Vaerman JL, Davi F, Dastugue N, Raynaud S, Lafage M, Deschaseaux F, Fest T, Gaub MP, Lheritier V, Thomas X, Charrin C, Boucheix C, Dombret H, Macintyre E, Fiere D, Gabert J. Prospective multicentric molecular study for poor prognosis fusion transcripts at diagnosis in adult B-lineage ALL patients: the LALA 94 experience. Leukemia. 2006 Dec;20(12):2178-81. doi: 10.1038/sj.leu.2404408. Epub 2006 Oct 12. No abstract available.

ReferenceCitation: Charrin C, Thomas X, Ffrench M, Le QH, Andrieux J, Mozziconacci MJ, Lai JL, Bilhou-Nabera C, Michaux L, Bernheim A, Bastard C, Mossafa H, Perot C, Maarek O, Boucheix C, Lheritier V, Delannoy A, Fiere D, Dastugue N. A report from the LALA-94 and LALA-SA groups on hypodiploidy with 30 to 39 chromosomes and near-triploidy: 2 possible expressions of a sole entity conferring poor prognosis in adult acute lymphoblastic leukemia (ALL). Blood. 2004 Oct 15;104(8):2444-51. doi: 10.1182/blood-2003-04-1299. Epub 2004 Mar 23.

ReferenceCitation: Boissel N, Auclerc MF, Lheritier V, Perel Y, Thomas X, Leblanc T, Rousselot P, Cayuela JM, Gabert J, Fegueux N, Piguet C, Huguet-Rigal F, Berthou C, Boiron JM, Pautas C, Michel G, Fiere D, Leverger G, Dombret H, Baruchel A. Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials. J Clin Oncol. 2003 Mar 1;21(5):774-80. doi: 10.1200/JCO.2003.02.053. Epub 2003 Mar 1.

ReferenceCitation: Labar B, Suciu S, Willemze R, Muus P, Marie JP, Fillet G, Berneman Z, Jaksic B, Feremans W, Bron D, Sinnige H, Mistrik M, Vreugdenhil G, De Bock R, Nemet D, Gilotay C, Amadori S, de Witte T; EORTC Leukemia Group. Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group. Haematologica. 2010 Sep;95(9):1489-95. doi: 10.3324/haematol.2009.018580. Epub 2010 Apr 7.

ReferenceCitation: Le QH, Thomas X, Ecochard R, Iwaz J, Lheritier V, Michallet M, Fiere D. Proportion of long-term event-free survivors and lifetime of adult patients not cured after a standard acute lymphoblastic leukemia therapeutic program: adult acute lymphoblastic leukemia-94 trial. Cancer. 2007 May 15;109(10):2058-67. doi: 10.1002/cncr.22632.

ReferenceCitation: Tavernier E, Boiron JM, Huguet F, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lheritier V, Vernant JP, Dombret H, Thomas X; GET-LALA Group; Swiss Group for Clinical Cancer Research SAKK; Australasian Leukaemia and Lymphoma Group. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia. 2007 Sep;21(9):1907-14. doi: 10.1038/sj.leu.2404824. Epub 2007 Jul 5.

ReferenceCitation: Vey N, Thomas X, Picard C, Kovascovicz T, Charin C, Cayuela JM, Dombret H, Dastugue N, Huguet F, Bastard C, Stamatoulas A, Giollant M, Tournilhac O, Macintyre E, Buzyn A, Bories D, Kuentz M, Dreyfus F, Delannoy A, Raynaud S, Gratecos N, Bordessoule D, de Botton S, Preudhomme C, Reman O, Troussard X, Pigneux A, Bilhou C, Vernant JP, Boucheix C, Gabert J; GET-LALA Group the Swiss Group for Clinical Cancer Research (SAKK). Allogeneic stem cell transplantation improves the outcome of adults with t(1;19)/E2A-PBX1 and t(4;11)/MLL-AF4 positive B-cell acute lymphoblastic leukemia: results of the prospective multicenter LALA-94 study. Leukemia. 2006 Dec;20(12):2155-61. doi: 10.1038/sj.leu.2404420. Epub 2006 Oct 12.

ReferenceCitation: Asnafi V, Buzyn A, Thomas X, Huguet F, Vey N, Boiron JM, Reman O, Cayuela JM, Lheritier V, Vernant JP, Fiere D, Macintyre E, Dombret H. Impact of TCR status and genotype on outcome in adult T-cell acute lymphoblastic leukemia: a LALA-94 study. Blood. 2005 Apr 15;105(8):3072-8. doi: 10.1182/blood-2004-09-3666. Epub 2005 Jan 6.

ReferenceCitation: Thomas X, Boiron JM, Huguet F, Dombret H, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Vernant JP, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lheritier V, Fiere D. Outcome of treatment in adults with acute lymphoblastic leukemia: analysis of the LALA-94 trial. J Clin Oncol. 2004 Oct 15;22(20):4075-86. doi: 10.1200/JCO.2004.10.050. Epub 2004 Sep 7.

ReferenceCitation: Asnafi V, Buzyn A, Thomas X, et al.: Impact of immunophenotype and genotype on outcome in LALA94 T-ALLs: toward risk adapted stratification of adult T-ALL. [Abstract] Blood 102 (11): A-67, 2003.

ReferenceCitation: Dombret H, Gabert J, Boiron JM, Rigal-Huguet F, Blaise D, Thomas X, Delannoy A, Buzyn A, Bilhou-Nabera C, Cayuela JM, Fenaux P, Bourhis JH, Fegueux N, Charrin C, Boucheix C, Lheritier V, Esperou H, MacIntyre E, Vernant JP, Fiere D; Groupe d'Etude et de Traitement de la Leucemie Aigue Lymphoblastique de l'Adulte (GET-LALA Group). Outcome of treatment in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia--results of the prospective multicenter LALA-94 trial. Blood. 2002 Oct 1;100(7):2357-66. doi: 10.1182/blood-2002-03-0704.

location_country:
Germany
Italy
Portugal
Slovakia
Netherlands
Belgium
Turkey
Croatia
Czech Republic
France

location_facility: Institute of Hematology & Transfusiology, University Hospital

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: Maxima Medisch Centrum - locatie Eindhoven

location_facility: Ospedale Gen. Provinciale Santa Maria Goretti

location_facility: Universita Degli Studi di Bari Policlinico


title: A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)

summary: The purpose of this study is to evaluate the safety and tolerability of ANV419 monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab.

ipd_sharing: No

lead_sponsor: Anaveon AG

location_country: Germany Denmark Switzerland Spain France

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)


title: A Retrospective, Multicenter, International Study to Characterize the Natural History of Danon Disease

summary:
This is a multicenter, international, non-interventional, natural history study designed to collect longitudinal retrospective clinical information on patients with Danon disease (DD). This study is composed of 2 parts:

Feasibility study: to identify participating sites, assess site and team capabilities, confirm the site and investigator qualification for taking part in the study,
Retrospective chart review: Data will be collected retrospectively by means of a chart review of living and/or deceased DD patients with a confirmed lysosome associated membrane protein-2 gene (LAMP2) mutation, and,
For living patients (who have not undergone heart transplantation or placement of a cardiac assist device), availability of at least 6-month cardiology follow-up data,
For living patients who underwent heart transplantation or placement of a cardiac assist device, and for deceased patients, at least 1 MRI or echo assessment prior to heart transplantation/cardiac assist device placement or death.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Rocket Pharmaceuticals Inc.

location_country: Ireland Italy Spain Czechia France

location_facility: Hospital Universitario Virgen de la Victoria- Virgen de la Victoria University Hosptial

location_facility: University of Florence Dept. of Experimental and Clinical Medicine

location_facility: Hospital Clínic de Barcelona - Barnaclínic+

location_facility: Hospital Universitario de Bellvitge- Bellvitge University Hospital

location_facility: Institut klinické a experimentální medicíny (IKEM)- Institute for Clinical and Experimental Medicine

location_facility: Hospital Universitario La Paz - La Paz University Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda Puerta de Hierro Majadahonda - University Hospital

location_facility: Ospedale Papa Giovanni XXIII di Bergamo ASST Pap Giovanni XXIII Hospital

location_facility: Hospital Universitario y Politécnico La Fe, Instituto De Investigación Sanitaria La Fe, La Fe University and Polytechnic Hospital

location_facility: APHP, Hôpital de la Pitié Salppêtrière - Charles Foix

location_facility: IRCCS Burlo Garogolo- Hospital Burlo Garofolo

intervention_type: Procedure


type: EudraCT Number

type: Registry Identifier

type: Other Identifier

title: A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

summary: The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
United States
Korea, Republic of
Spain
Russian Federation
France

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Centre Hospitalier Universitaire (CHU) de Caen

location_facility: Republican Hospital named by V.A.Baranova

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: S.P. Botkin Moscow City Clinical Hospital

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

status_simplified: Ongoing


title: A Phase 1b Study in Patients With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) to Characterize the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Debio 4126, a 12-week Prolonged-release Octreotide Formulation

summary: This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).

status: Active, not recruiting

design_allocation: Non-Randomized

lead_sponsor: Debiopharm International SA

location_country:
Germany
Italy
France
Poland
United Kingdom
Denmark
Spain
Israel

location_facility: Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii

location_facility: AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyse

location_facility: Medicover Praxis fur Neuroendokrinologie

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

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Sheba Medical Center, Endocrine institute

location_facility: Hospital de la Santa Creu i Sant Pau Barcelon

location_facility: Rabin Medical Center, Beilinson Hospital, Clalit Health Services by Rabin Medical Center, Beilinson Hospita

location_facility: University Hospital Coventry, WISDEM Centre, UHCW NHS Trust


title: Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)

acronym: ORCHID

summary:
Primary Objective:

To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review

Secondary Objectives:

To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting:

ORR according to Lugano classification and as assessed by treating physician evaluation

Complete Response (CR) rate according to Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation

Progression Free Survival (PFS) according to Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation
Overall Survival (OS)

Duration of response (DOR) according to Lugano classification and as assessed by

Independent central review and
Treating physician evaluation

Disease control rate (DCR) according to Lugano classification and as assessed by:

Independent central reviewed
Treating physician evaluation
Time to next treatment (TTNT)

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Germany
United Kingdom
Austria
France

intervention_type: Other


title: Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated With Systemic Therapy in a Real-World Assessment (FLORA)

acronym: FLORA

summary:
Primary Objective:

To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review.

Secondary Objectives:

To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting:

Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation

Complete response (CR) rate according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation

Progression-free survival (PFS) according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation
Overall survival (OS)

Duration of response (DOR) according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation

Disease control rate (DCR) according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation
Time to next treatment (TTNT)
Histological transformation (HT)


title: Phase 1/2 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2002 in Adults With Hereditary Angioedema (HAE)

summary: This study will be conducted to evaluate the safety, tolerability, activity, pharmacokinetics, and pharmacodynamics of NTLA-2002 in adults with Hereditary Angioedema (HAE).

lead_sponsor: Intellia Therapeutics

location_country:
Germany
New Zealand
United Kingdom
Australia
Netherlands
France


title: A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study With Open-Label Extension to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of LMI070/Branaplam Administered as Weekly Oral Doses in Participants With Early Manifest Huntington's Disease

acronym: VIBRANT-HD

summary: This is the first study of branaplam in adults with Huntington's Disease (HD) to determine the correct dose required to lower mutant huntingtin protein (mHTT) levels in the cerebrospinal fluid (CSF) to a degree expected to be efficacious over longer periods of time.

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany Hungary Spain Canada France


acronym: cASPerCF

lead_sponsor: Bambino Gesù Hospital and Research Institute

summary: This study will provide: (1) new insights in the prevalence of Aspergillus infection in children and adolescents with CF aged 8-17 yrs; (2) an in silico modelled dose of posaconazole for children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (3) an intensive sampling PK study to define the optimal dose in a limited number of children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (4) a prospective clinical validation to reduce the residual variability and to allow investigation into PK-PD; and (5) an efficacy evaluation of this dosing regimen to treat Aspergillus infection in children and adolescents with CF to inform future primary efficacy trials.

ReferenceCitation: Armstead J, Morris J, Denning DW. Multi-country estimate of different manifestations of aspergillosis in cystic fibrosis. PLoS One. 2014 Jun 10;9(6):e98502. doi: 10.1371/journal.pone.0098502. eCollection 2014.

ReferenceCitation: Rowbotham NJ, Smith S, Prayle AP, Robinson KA, Smyth AR. Gaps in the evidence for treatment decisions in cystic fibrosis: a systematic review. Thorax. 2019 Mar;74(3):229-236. doi: 10.1136/thoraxjnl-2017-210858. Epub 2018 Oct 9.

ReferenceCitation: Boyle M, Moore JE, Whitehouse JL, Bilton D, Downey DG. The diagnosis and management of respiratory tract fungal infection in cystic fibrosis: A UK survey of current practice. Med Mycol. 2019 Feb 1;57(2):155-160. doi: 10.1093/mmy/myy014.

ReferenceCitation: Welzen ME, Bruggemann RJ, Van Den Berg JM, Voogt HW, Gilissen JH, Pajkrt D, Klein N, Burger DM, Warris A. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease. Pediatr Infect Dis J. 2011 Sep;30(9):794-7. doi: 10.1097/INF.0b013e3182195808.

ReferenceCitation: Groll AH, Abdel-Azim H, Lehrnbecher T, Steinbach WJ, Paschke A, Mangin E, Winchell GA, Waskin H, Bruno CJ. Pharmacokinetics and safety of posaconazole intravenous solution and powder for oral suspension in children with neutropenia: an open-label, sequential dose-escalation trial. Int J Antimicrob Agents. 2020 Sep;56(3):106084. doi: 10.1016/j.ijantimicag.2020.106084. Epub 2020 Jul 17.

ReferenceCitation: King J, Brunel SF, Warris A. Aspergillus infections in cystic fibrosis. J Infect. 2016 Jul 5;72 Suppl:S50-5. doi: 10.1016/j.jinf.2016.04.022. Epub 2016 May 11.

ReferenceCitation: Periselneris J, Nwankwo L, Schelenz S, Shah A, Armstrong-James D. Posaconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with cystic fibrosis. J Antimicrob Chemother. 2019 Jun 1;74(6):1701-1703. doi: 10.1093/jac/dkz075.

ReferenceCitation: Dolton MJ, Bruggemann RJ, Burger DM, McLachlan AJ. Understanding variability in posaconazole exposure using an integrated population pharmacokinetic analysis. Antimicrob Agents Chemother. 2014 Nov;58(11):6879-85. doi: 10.1128/AAC.03777-14. Epub 2014 Sep 8.

ReferenceCitation: Castellani C, Duff AJA, Bell SC, Heijerman HGM, Munck A, Ratjen F, Sermet-Gaudelus I, Southern KW, Barben J, Flume PA, Hodkova P, Kashirskaya N, Kirszenbaum MN, Madge S, Oxley H, Plant B, Schwarzenberg SJ, Smyth AR, Taccetti G, Wagner TOF, Wolfe SP, Drevinek P. ECFS best practice guidelines: the 2018 revision. J Cyst Fibros. 2018 Mar;17(2):153-178. doi: 10.1016/j.jcf.2018.02.006. Epub 2018 Mar 3.

ReferenceCitation: Patel D, Popple S, Claydon A, Modha DE, Gaillard EA. Posaconazole therapy in children with cystic fibrosis and Aspergillus-related lung disease. Med Mycol. 2020 Jan 1;58(1):11-21. doi: 10.1093/mmy/myz015.

ReferenceCitation: Krishna G, Ma L, Martinho M, Preston RA, O'Mara E. A new solid oral tablet formulation of posaconazole: a randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers. J Antimicrob Chemother. 2012 Nov;67(11):2725-30. doi: 10.1093/jac/dks268. Epub 2012 Jul 24.

ReferenceCitation: Tragiannidis A, Herbruggen H, Ahlmann M, Vasileiou E, Gastine S, Thorer H, Frohlich B, Muller C, Groll AH. Plasma exposures following posaconazole delayed-release tablets in immunocompromised children and adolescents. J Antimicrob Chemother. 2019 Dec 1;74(12):3573-3578. doi: 10.1093/jac/dkz359.

sponsor_collaborators: Consorzio per Valutazioni Biologiche e Farmacologiche

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: ASST Spedali Civili Paediatric department

location_facility: Centro Hospitalar Universitário Lisboa Norte EPE

location_facility: University Hospital Nottingham (Queens Medical Centre)

location_facility: Centre hospitalier universitaire Grenoble Alpes

location_facility: Cystic Fibrosis Department, "Agia Sofia" Children's Hospital

location_facility: Sheffield Childrens NHS Foundation Trust

location_facility: Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin, Pädiatrische Pneumologie/Allergologie/Mukoviszidose-Zentrum

location_facility: Medizinische Hochschule Hannover, Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie

location_facility: Universitätsklinikum Essen,Pediatric Pulmonology and Cystic Fibrosis Center

location_facility: University Medical Center Groningen (UMCG)

location_facility: University of Parma Department of Medicine and Surgery

location_facility: Hospital Universitario 12 de Octubre,Unidad Multidisciplinar Fibrosis Quística

location_facility: Hospital Universitario Materno Infantil Reina Sofia

location_facility: Centre hospitalier universitaire Dijon Bourgogne

location_facility: University Medical Center Utrecht (UMCU)

location_facility: Katholisches Klinikum Bochum gGMBH, Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum, St. Josef Hospital

location_facility: Radboud University Medical Center (RUMC)

location_facility: Centre hospitalier universitaire de Montpellier

location_facility: Technische Universität Dresden, Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Cystic Fibrosis Center, 3rd Paediatric Dept, Aristotle University of Thessaloniki

title: Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection

source: euctr

ipd_sharing_description: All IPD that underlie results in a publication

location_country:
Ireland
Germany
Italy
Portugal
United Kingdom
Netherlands
Switzerland
Spain
Greece
Czechia
France

lead_sponsor_type: academique


title: Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

acronym: TRANSFORM II

summary: International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).

ReferenceCitation: Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol. 2014 Jan;11(1):13-23. doi: 10.1038/nrcardio.2013.165. Epub 2013 Nov 5.

ReferenceCitation: Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, Limbruno U. Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart. 2010 Aug;96(16):1291-6. doi: 10.1136/hrt.2010.195057.

ReferenceCitation: Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011 May;7 Suppl K:K53-6. doi: 10.4244/EIJV7SKA9.

ReferenceCitation: Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14. Erratum In: J Am Coll Cardiol. 2013 Apr 16;61(15):1660.

ReferenceCitation: Cortese B, Sgueglia GA, Berti S, Biondi-Zoccai G, Colombo A, Limbruno U, Bedogni F, Cremonesi A; Italian Society of Interventional Cardiology (SICI-GISE). [SICI-GISE position paper on drug-coated balloon use in the coronary district]. G Ital Cardiol (Rome). 2013 Oct;14(10):681-9. doi: 10.1714/1335.14836. Italian.

ReferenceCitation: Cortese B, Berti S, Biondi-Zoccai G, Colombo A, Limbruno U, Bedogni F, Cremonesi A, Silva PL, Sgueglia GA; Italian Society of Interventional Cardiology. Drug-coated balloon treatment of coronary artery disease: a position paper of the Italian Society of Interventional Cardiology. Catheter Cardiovasc Interv. 2014 Feb 15;83(3):427-35. doi: 10.1002/ccd.25149. Epub 2013 Sep 23.

ReferenceCitation: Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.

ReferenceCitation: B. Cortese et Al., PICCOLETO II study, JACC Interventions, 2020, in press

ReferenceCitation: Scheller B, Vukadinovic D, Jeger R, Rissanen TT, Scholz SS, Byrne R, Kleber FX, Latib A, Clever YP, Ewen S, Bohm M, Yang Y, Lansky A, Mahfoud F. Survival After Coronary Revascularization With Paclitaxel-Coated Balloons. J Am Coll Cardiol. 2020 Mar 10;75(9):1017-1028. doi: 10.1016/j.jacc.2019.11.065.

ReferenceCitation: Lemos PA, Farooq V, Takimura CK, Gutierrez PS, Virmani R, Kolodgie F, Christians U, Kharlamov A, Doshi M, Sojitra P, van Beusekom HM, Serruys PW. Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter. EuroIntervention. 2013 May 20;9(1):148-56. doi: 10.4244/EIJV9I1A21.

ReferenceCitation: Cortese B, di Palma G, Latini RA, Elwany M, Orrego PS, Seregni RG. Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry. Cardiovasc Revasc Med. 2017 Oct-Nov;18(7):487-491. doi: 10.1016/j.carrev.2017.03.025. Epub 2017 Mar 25.

ReferenceCitation: Cortese B, Pellegrini D, Latini RA, Di Palma G, Perotto A, Orrego PS. Angiographic performance of a novel sirolimus-coated balloon in native coronary lesions: the FAtebenefratelli SIrolimus COated NATIVES prospective registry. J Cardiovasc Med (Hagerstown). 2019 Jul;20(7):471-476. doi: 10.2459/JCM.0000000000000806.

ReferenceCitation: Cortese B, Testa L, Di Palma G, Heang TM, Bossi I, Nuruddin AA, Ielasi A, Tespili M, Perez IS, Milazzo D, Benincasa S, Latib A, Cacucci M, Caiazzo G, Seresini G, Tomai F, Ocaranza R, Torres A, Perotto A, Bedogni F, Colombo A. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry. J Cardiovasc Med (Hagerstown). 2021 Feb 1;22(2):94-100. doi: 10.2459/JCM.0000000000001070.

ReferenceCitation: Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.

ReferenceCitation: Cortese B, Silva Orrego P, Agostoni P, Buccheri D, Piraino D, Andolina G, Seregni RG. Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection. JACC Cardiovasc Interv. 2015 Dec 28;8(15):2003-2009. doi: 10.1016/j.jcin.2015.08.029. Epub 2015 Nov 25.

ReferenceCitation: Onishi T, Onishi Y, Kobayashi I, Sato Y. Late lumen enlargement after drug-coated balloon angioplasty for de novo coronary artery disease. Cardiovasc Interv Ther. 2021 Jul;36(3):311-318. doi: 10.1007/s12928-020-00690-2. Epub 2020 Jul 9. Erratum In: Cardiovasc Interv Ther. 2020 Sep 17;:

ReferenceCitation: Greco A, Sciahbasi A, Abizaid A, Mehran R, Rigattieri S, de la Torre Hernandez JM, Alfonso F, Cortese B. Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):544-552. doi: 10.1002/ccd.30358. Epub 2022 Sep 2.

publisher_dissemination: Wiley

lead_sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS

location_country: Italy Netherlands Spain Bangladesh France

location_facility: National Heart Foundation Hospital & Research Institute

location_facility: Hospital Universitario Marqués de Valdecilla (HUMV)

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Hospital General Universitario de Ciudad Real (HGUCR)

location_facility: Hospital Universitario Lucus Augusti (HULA)

location_facility: OLVG Onze Lieve Vrouwe Gasthuis location East

intervention_type: Device


lead_sponsor: Imara, Inc.

summary: A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia

location_facility: Centre Hôpital Universitaire Farhat Hached

location_facility: Amsterdam Universitair Medische Centra - Academisch Medisch Centrum

location_facility: Medinvest - Institute of Hematology and Transfusiology

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre National de Greffe de la Moelle Osseuse

location_facility: Hospital Queen Elizabeth - Kota Kinabalu

location_facility: Manchester University NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

title: A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects With Beta Thalassemia

location_country:
France
Italy
United Kingdom
Denmark
Netherlands
Lebanon
Tunisia
Greece
Malaysia
Morocco
Turkey
Georgia
Israel


title: Outcomes and Prognostic Factors in Coronavirus Disease (COVID-19) in Very Old Intensive Care Patients

acronym: COVIP

summary: The primary aim is to study the short-term outcome of elderly ICU patients (≥ 70 years) suffering from COVID-19 using a multicenter and multi-national approach. The secondary aim is to investigate the properties of a simple frailty scale in this cohort, and in particular if this is an instrument that can be used for outcome prediction in this group. In addition, various other parameters of potential relevance for older critically ill patients will be studied.

time_perspective: Prospective

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Flaatten H, de Lange DW, Artigas A, Bin D, Moreno R, Christensen S, Joynt GM, Bagshaw SM, Sprung CL, Benoit D, Soares M, Guidet B. The status of intensive care medicine research and a future agenda for very old patients in the ICU. Intensive Care Med. 2017 Sep;43(9):1319-1328. doi: 10.1007/s00134-017-4718-z. Epub 2017 Feb 25.

ReferenceCitation: Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.

ReferenceCitation: Rockwood K, Stadnyk K, MacKnight C, McDowell I, Hebert R, Hogan DB. A brief clinical instrument to classify frailty in elderly people. Lancet. 1999 Jan 16;353(9148):205-6. doi: 10.1016/S0140-6736(98)04402-X. No abstract available.

ReferenceCitation: Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Zafeiridis T, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjolner J, Flaatten H; VIP2 study group. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020 Jan;46(1):57-69. doi: 10.1007/s00134-019-05853-1. Epub 2019 Nov 29.

ReferenceCitation: Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.

ReferenceCitation: Jung C, Wernly B, Muessig JM, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjolner J, Lichtenauer M, Bruno RR, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zafeiridis T, De Lange DW, Guidet B, Flaatten H; VIP1 study group. Electronic address: hans.flaatten@uib.no. A comparison of very old patients admitted to intensive care unit after acute versus elective surgery or intervention. J Crit Care. 2019 Aug;52:141-148. doi: 10.1016/j.jcrc.2019.04.020. Epub 2019 May 2.

ReferenceCitation: Wolff G, Wernly B, Flaatten H, Fjolner J, Bruno RR, Artigas A, Pinto BB, Schefold JC, Kelm M, Binneboessel S, Baldia P, Beil M, Sivri S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Flamm M, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Boumendil A, De Lange DW, Guidet B, Leaver S, Jung C; COVIP Study Group. Sex-specific treatment characteristics and 30-day mortality outcomes of critically ill COVID-19 patients over 70 years of age-results from the prospective COVIP study. Can J Anaesth. 2022 Nov;69(11):1390-1398. doi: 10.1007/s12630-022-02304-2. Epub 2022 Aug 9.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Universidade Nova de Lisboa - Universidade Nova de Lisboa's Repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Polok K, Fronczek J, Artigas A, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Bollen Pinto B, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP Study Group. Noninvasive ventilation in COVID-19 patients aged >/= 70 years-a prospective multicentre cohort study. Crit Care. 2022 Jul 22;26(1):224. doi: 10.1186/s13054-022-04082-1.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Radboud University - Radboud Repository

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

repository_institution: St George's University of London - St George's Online Research Archive

ReferenceCitation: Bruno RR, Wernly B, Flaatten H, Fjolner J, Artigas A, Baldia PH, Binneboessel S, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Kondili E, Marsh B, Wollborn J, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Jung C; COVIP study group. The association of the Activities of Daily Living and the outcome of old intensive care patients suffering from COVID-19. Ann Intensive Care. 2022 Mar 18;12(1):26. doi: 10.1186/s13613-022-00996-9.

repository_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Bruno RR, Wernly B, Wolff G, Fjolner J, Artigas A, Bollen Pinto B, Schefold JC, Kindgen-Milles D, Baldia PH, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Topeli A, Elhadi M, Joannidis M, Oeyen S, Kondili E, Marsh B, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Flaatten H, Jung C; COVIP study group. Association of chronic heart failure with mortality in old intensive care patients suffering from Covid-19. ESC Heart Fail. 2022 Jun;9(3):1756-1765. doi: 10.1002/ehf2.13854. Epub 2022 Mar 10.

repository_institution: Hospital Center of Central Lisbon - Repository of the Hospital Center of Lisbon Central

ReferenceCitation: Guidet B, Jung C, Flaatten H, Fjolner J, Artigas A, Pinto BB, Schefold JC, Beil M, Sigal S, van Heerden PV, Szczeklik W, Joannidis M, Oeyen S, Kondili E, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, De Lange DW, Boumendil A; VIP2 and COVIP study groups. Increased 30-day mortality in very old ICU patients with COVID-19 compared to patients with respiratory failure without COVID-19. Intensive Care Med. 2022 Apr;48(4):435-447. doi: 10.1007/s00134-022-06642-z. Epub 2022 Feb 26. Erratum In: Intensive Care Med. 2022 Mar 31;:

ReferenceCitation: Jung C, Mamandipoor B, Fjolner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, De Lange DW, Guidet B, Flaatten H, Osmani V. Disease-Course Adapting Machine Learning Prognostication Models in Elderly Patients Critically Ill With COVID-19: Multicenter Cohort Study With External Validation. JMIR Med Inform. 2022 Mar 31;10(3):e32949. doi: 10.2196/32949.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: New University of Lisbon - New University of Lisbon's Repository

ReferenceCitation: Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.

ReferenceCitation: Jung C, Flaatten H, de Lange D, Beil M, Guidet B. The relationship between treatment limitations and pressure on intensive care units in elderly patients. Intensive Care Med. 2022 Jan;48(1):124-125. doi: 10.1007/s00134-021-06553-5. Epub 2021 Nov 5. No abstract available.

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

ReferenceCitation: Jung C, Fjolner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Joannidis M, Oeyen S, Zafeiridis T, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Flaatten H; , COVIP Study Group. Differences in mortality in critically ill elderly patients during the second COVID-19 surge in Europe. Crit Care. 2021 Sep 23;25(1):344. doi: 10.1186/s13054-021-03739-7.

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

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repositories_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Bruno RR, Wernly B, Flaatten H, Fjolner J, Artigas A, Bollen Pinto B, Schefold JC, Binnebossel S, Baldia PH, Kelm M, Beil M, Sigal S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Wollborn J, Arche Banzo MJ, Fuest K, Marsh B, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Jung C; COVIP Study Group. Lactate is associated with mortality in very old intensive care patients suffering from COVID-19: results from an international observational study of 2860 patients. Ann Intensive Care. 2021 Aug 21;11(1):128. doi: 10.1186/s13613-021-00911-8.

ReferenceCitation: Jung C, Flaatten H, Fjolner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, Boumendil A, De Lange DW, Guidet B; COVIP study group. The impact of frailty on survival in elderly intensive care patients with COVID-19: the COVIP study. Crit Care. 2021 Apr 19;25(1):149. doi: 10.1186/s13054-021-03551-3.

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

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

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

ReferenceCitation: Jung C, Bruno RR, Wernly B, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Fernandes AM, Artigas A, Pinto BB, Schefold J, Wolff G, Kelm M, De Lange DW, Guidet B, Flaatten H, Fjolner J; COVIP study group. Inhibitors of the renin-angiotensin-aldosterone system and COVID-19 in critically ill elderly patients. Eur Heart J Cardiovasc Pharmacother. 2021 Jan 16;7(1):76-77. doi: 10.1093/ehjcvp/pvaa083. No abstract available.

location_facility: Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale

location_facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine

location_facility: INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique

location_facility: Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique

location_facility: Department of Clinical Medecine,University of Bergen

location_facility: Department of Intensive Care, Aarhus University Hospital

location_facility: Department of Anaestesia and Intensive Care, Haukeland University Hospital


title: Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon

summary:
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

lead_sponsor: Interscope, Inc.

location_country:
United States
Italy
Germany
France

location_facility: Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Humanitas Research Hospital & Humanitas University

location_facility: Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica


title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of ION464 Administered Intrathecally to Adults With Multiple System Atrophy

acronym: HORIZON

summary:
The primary objectives are to evaluate the safety and tolerability of multiple doses of ION464 administered via intrathecal (IT) injection (Part 1) and to evaluate the long-term safety and tolerability of ION464 (Part 2) in participants with multiple system atrophy (MSA).

The secondary objectives are to evaluate the pharmacodynamic (PD) effect of ION464 on the level of a potential biomarker of target engagement (Parts 1 and 2) and to evaluate the pharmacokinetic (PK) profile of ION464 in serum (Part 1).

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Germany
Portugal
United Kingdom
Austria
France

location_facility: Institute of Neurology & The National Hospital for Neurology and Neurosurgery


title: Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia

summary: The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Spain
Australia
United Kingdom
France

location_facility: Centre Hospitalier Universitaire Régionale de Lille Hôpital Huriez

location_facility: Clínica Universidad Navarra- Servicio de Hematología

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Universitario La Fe - Servicio de Hematología - Torre F - Planta 7

location_facility: CHU de Nice - Hôpital l'Archet 1 Hématologie clinique

location_facility: The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services

location_facility: Hospital Clínico Universitario de Salamanca- Servicio de Hematología (4a planta)


title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

summary:
A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.

Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.

lead_sponsor: Medi-Tate Ltd.

location_country: Germany Italy Australia Switzerland Spain France

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Sydney Adventist Hospital Clinical School of the University of Sydney


title: Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study

acronym: STEAM

summary: This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.

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

location_country: Germany Netherlands Austria Switzerland France

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie

location_facility: Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg