acronym: DELOS

lead_sponsor: Santhera Pharmaceuticals

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

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

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

repository_institution: Leiden University - Leiden Repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: LIRIAS (KU Leuven);UCL Discovery;scholarlypublications.universiteitleiden.nl

location_facility: Azienda Ospedaliera Niguarda Ca' Granda Centro Clinico Nemo

location_facility: Universitätsklinikum Essen, Zentrum für Kinderheikunde

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

location_facility: Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin

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

location_facility: University Hospitals Leuven- Children Hospital

location_facility: University of California Davis Medical Center

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Carolinas Medical Center, Neurosciences and Spine Institute

location_facility: University of Texas Southwestern Medical Center

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

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


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

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

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Teva Pharmaceutical Industries, Ltd.

location_country:
Germany
Italy
France
United Kingdom
Belgium
Israel

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


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

acronym: PLATFORM

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

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

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

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

version: publishedVersion

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: Elsevier

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

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

lead_sponsor: HeartFlow, Inc.

sponsor_collaborators:
HeartFlow, Inc.
Duke Clinical Research Institute

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

location_facility: Innsbruck Medical University, Department of Radiology II

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Duke University Clinical Research Institution

location_facility: University Hospital Southampton NHS Foundation Trust

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

location_facility: Freeman Hospital - Therapeutics & Cardiac Research Team

location_facility: LKH-GRAZ-West - Department of Cardiology

location_facility: Deutsches Herzzentrum München - ISAResearch Centre


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

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

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

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.

lead_sponsor: AstraZeneca

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


type: Other Identifier

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

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

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Université Lille 3
Aix Marseille Université
University of Paris 5 - Rene Descartes
SIRIC ONCOLille
Canceropôle Nord Ouest
National Cancer Institute, France

location_facility: Le Confluent - Centre Catherine de Sienne

location_facility: Unité d'Oncologie et d'hématologie ONCOSUD

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

intervention_type: Other

status_simplified: Unknown


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

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

lead_sponsor: Novartis Pharmaceuticals

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

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


type: Registry Identifier

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

acronym: RESCAP

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

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

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

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

lead_sponsor: University Hospital, Tours

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

collaborators: Centre Hospitalier Universitaire de Pointe-a-Pitre

location_country: Guadeloupe France

location_facility:
Uniersity Hospital
Urology CHRU-TOURS
University Hospital

intervention_type: Procedure

lead_sponsor_type: academique


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

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

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

evidence: open (via page says license)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: Wolters Kluwer Health

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

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Cambridge University Press

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

publisher_dissemination: Informa

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

publisher_dissemination: Physicians Postgraduate Press, Inc

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

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

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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


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

acronym: POLAR

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

primary_purpose: Diagnostic

lead_sponsor: Lille Catholic University

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Intercommunal Poissy-St-Germain

location_facility: Centre Hospitalier Régional Universitaire de Strasbourg

location_facility: Centre Hospitalier Univetrsitaire de Rouen

location_facility: Centre Hospitalier Régional Universitaire de Lille


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

acronym: LARMES

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

sponsor_collaborators:
Lille Catholic University
Bayer

location_facility: Centre hospitalier universitaire (CHU), Nice

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

location_facility: Centre hospitalier régional universtaire

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Centre hospitalier régional universitaire


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

lead_sponsor: Merck Sharp & Dohme LLC

summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.

ReferenceType: result

ReferenceCitation: Yu EY, Piulats JM, Gravis G, Fong PCC, Todenhofer T, Laguerre B, Arranz JA, Oudard S, Massard C, Heinzelbecker J, Nordquist LT, Carles J, Kolinsky MP, Augustin M, Gurney H, Tafreshi A, Li XT, Qiu P, Poehlein CH, Schloss C, de Bono JS. Pembrolizumab plus Olaparib in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort A Study. Eur Urol. 2023 Jan;83(1):15-26. doi: 10.1016/j.eururo.2022.08.005. Epub 2022 Aug 30. Erratum In: Eur Urol. 2023 Mar;83(3):e87.

oa_host_type: publisher

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

location_facility: Call for Information (Investigational Site 2041)

location_facility: Call for Information (Investigational Site 0007)

location_facility: Call for Information (Investigational Site 2002)

location_facility: Call for Information (Investigational Site 0008)

location_facility: Call for Information (Investigational Site 2027)

location_facility: Call for Information (Investigational Site 2080)

location_facility: Call for Information (Investigational Site 2083)

location_facility: Call for Information (Investigational Site 2094)

location_facility: Call for Information (Investigational Site 0010)

location_facility: Call for Information (Investigational Site 2090)

location_facility: Call for Information (Investigational Site 2091)

location_facility: Call for Information (Investigational Site 0004)

location_facility: Call for Information (Investigational Site 2084)

location_facility: Call for Information (Investigational Site 2065)

location_facility: Call for Information (Investigational Site 0005)

location_facility: Call for Information (Investigational Site 2086)

location_facility: Call for Information (Investigational Site 2018)

location_facility: Call for Information (Investigational Site 0016)

status: Recruiting

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

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

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

ipd_sharing: Yes

status_simplified: Ongoing


intervention_type: Biological

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

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

publisher_dissemination: American Society of Clinical Oncology (ASCO)

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

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

repository_institution: Yonsei University Medical Library - YUHSpace

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

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

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

evidence: open (via free pdf)

unpaywall_oa_status: bronze

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

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

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

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

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

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

repository_institution: University of Illinois at Chicago - INDIGO

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

repository_institution: California Digital Library - eScholarship

publisher_dissemination: American Association for Cancer Research

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

location_facility: Call for Information (Investigational Site 0202)

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

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


title: A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination With Other Investigational Agents in Subjects With High Risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

summary: In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy or pembrolizumab in combination with other investigational agents. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

ReferenceCitation: Balar AV, Kamat AM, Kulkarni GS, Uchio EM, Boormans JL, Roumiguie M, Krieger LEM, Singer EA, Bajorin DF, Grivas P, Seo HK, Nishiyama H, Konety BR, Li H, Nam K, Kapadia E, Frenkl T, de Wit R. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol. 2021 Jul;22(7):919-930. doi: 10.1016/S1470-2045(21)00147-9. Epub 2021 May 26. Erratum In: Lancet Oncol. 2021 Aug;22(8):e347.

location_country:
Finland
Italy
Singapore
Australia
Brazil
Netherlands
United States
Spain
Turkey
Canada
Puerto Rico
France

location_facility: Call for Information (Investigational Site 0081)

location_facility: Call for Information (Investigational Site 2400)

location_facility: Call for Information (Investigational Site 2402)

location_facility: Call for Information (Investigational Site 0018)

location_facility: Call for Information (Investigational Site 0084)

location_facility: Call for Information (Investigational Site 0009)

location_facility: Call for Information (Investigational Site 0074)

location_facility: Call for Information (Investigational Site 0078)

location_facility: Call for Information (Investigational Site 0072)

location_facility: Call for Information (Investigational Site 0080)

location_facility: Call for Information (Investigational Site 0002)

location_facility: Call for Information (Investigational Site 0023)


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

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

advanced melanoma (6 months to <18 years of age),
advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age),
relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or
advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or
advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age), or
with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in children 12 years to <18 years of age

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

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

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

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

location_facility: Call for Information (Investigational Site 0054)

location_facility: Call for Information (Investigational Site 0025)

location_facility: Call for Information (Investigational Site 0031)

location_facility: Call for Information (Investigational Site 0014)

location_facility: Call for Information (Investigational Site 0026)

location_facility: Call for Information (Investigational Site 0012)

location_facility: Call for Information (Investigational Site 0029)

location_facility: Call for Information (Investigational Site 0019)

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

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


title: European Dyspnoea Survey in the EMergency Departments

acronym: EuroDEM

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

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

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

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

lead_sponsor: Hopital Lariboisière

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

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


acronym: PLEO-CMT

lead_sponsor: Pharnext S.C.A.

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

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

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;dash.harvard.edu

unpaywall_oa_status: gold

publisher_dissemination: Springer

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

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

repository_institution: Max Planck Society - MPG.PuRe

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

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

repository_normalized: HAL

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access

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

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

ReferenceCitation: Attarian S, Vallat JM, Magy L, Funalot B, Gonnaud PM, Lacour A, Pereon Y, Dubourg O, Pouget J, Micallef J, Franques J, Lefebvre MN, Ghorab K, Al-Moussawi M, Tiffreau V, Preudhomme M, Magot A, Leclair-Visonneau L, Stojkovic T, Bossi L, Lehert P, Gilbert W, Bertrand V, Mandel J, Milet A, Hajj R, Boudiaf L, Scart-Gres C, Nabirotchkin S, Guedj M, Chumakov I, Cohen D. Erratum to: An exploratory randomised double-blind and placebo-controlled phase 2 study of a combination of baclofen, naltrexone and sorbitol (PXT3003) in patients with Charcot-Marie-Tooth disease type 1A. Orphanet J Rare Dis. 2016 Jul 7;11(1):92. doi: 10.1186/s13023-016-0463-6. No abstract available.

location_facility: Department of Neurology, University of Minnesota

location_facility: Department of Neurology, Salford Royal NHS Foundation Trust

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

location_facility: Servicio de Neurologia, Hospital Universitario La Paz

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

location_facility: Department of Clinical Neurophysiology, University Medical Center Göttingen

location_facility: Department of Neurology, McKnight Brain Institute

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

location_facility: Department of Neurology, Cedars-Sinai Medical Center

location_facility: Department of neurology, Hospital Univesitario de Bellvitge

location_facility: Department of Neurology and Psichiatry, Saint Louis University

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

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

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

location_facility: Departement of Neurology, Academic Medical Center

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

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

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

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

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

location_facility: Service de Neurologie, Hôpital Kremlin Bicêtre

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

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


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

acronym: TOACT

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

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

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

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

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

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

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

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

status: Terminated

ReferenceType: background

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

ReferenceCitation: Canhao P, Falcao F, Ferro JM. Thrombolytics for cerebral sinus thrombosis: a systematic review. Cerebrovasc Dis. 2003;15(3):159-66. doi: 10.1159/000068833.

ReferenceCitation: Ciccone A, Canhao P, Falcao F, Ferro JM, Sterzi R. Thrombolysis for cerebral vein and dural sinus thrombosis. Cochrane Database Syst Rev. 2004;2004(1):CD003693. doi: 10.1002/14651858.CD003693.pub2.

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

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

oa_colors: green other

publisher_dissemination: American Medical Association

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

lead_sponsor: Jan Stam, MD, PhD

sponsor_collaborators:
Jan Stam, MD, PhD
Dutch Heart Foundation

location_country: Portugal Netherlands Switzerland China Canada France

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


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

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

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

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

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

sponsor_collaborators: AstraZeneca Pfizer

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


title: MOnitoring REsynchronization deviCes and cARdiac patiEnts

acronym: MORE-CARE

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

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

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

primary_purpose: Prevention

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

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

version: submittedVersion

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: JMIR Publications

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

publisher_dissemination: Oxford University Press

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

evidence: open (via free article)

repository_institution: University of Geneva - Archive ouverte UNIGE

lead_sponsor: Medtronic Bakken Research Center

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

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Gottsegen György Országos Kardiológia Intézet GOKI

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Policlinico Universitario S. Orsola-Malpighi

location_facility: Azienda Ospedaliera Sacro Cuore Don Calabria

location_facility: Ospedale Civile Maggiore di Borgo Trento

location_facility: Centre Hospitalier Universitaire de Angers

intervention_type: Device


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

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

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


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

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

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

ReferenceCitation: Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.

location_country:
Germany
Poland
United States
South Africa
Canada
France


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

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

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

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

ReferenceCitation: van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, Herrero-Beaumont G, Molad Y, Codreanu C, Valentini G, Zahora R, Pedersen R, MacPeek D, Wajdula J, Fatenejad S. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007 Dec;56(12):3928-39. doi: 10.1002/art.23141.

sponsor_collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

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


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

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

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

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

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

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


type: U.S. NIH Grant/Contract

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

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

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

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

publisher_dissemination: American Society of Hematology

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

repositories_concat: PubMed Central;air.unimi.it

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

lead_sponsor: Ronald Hoffman

location_country:
United States
Italy
United Kingdom
France

location_facility: Wake Forest University Baptist Medical Center

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


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

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

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

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


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

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

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

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

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

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

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

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

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

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Inc

sponsor_collaborators:
Astellas Pharma Inc
Seagen Inc.

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

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Texas Oncology - Baylor Sammons Cancer Center

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

location_facility: New York University (NYU) Cancer Institute

location_facility: University of California Irvine - Newport

location_facility: Keck Medical Center / University of Southern California

location_facility: Kaiser Permanente Medical Center Northern California

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Chao Family Comprehensive Cancer Center University of California Irvine

location_facility: James Cancer Hospital / Ohio State University

location_facility: Seattle Cancer Care Alliance / University of Washington

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

location_facility: H. Lee Moffitt Cancer Center & Research Institute


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

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

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

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

repository_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: Linkoping University - DiVA

publisher_dissemination: Springer-Nature

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

repository_institution: Uppsala University - Uppsala University Publications

repositories_concat: DiVA.org;PubMed Central

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

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

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

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

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

repository_institution: Anglia Ruskin University - Anglia Ruskin Research Online

repositories_institution: University of Illinois at Chicago - INDIGO

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

repository_institution: Monash University - Monash University Research Portal

repository_institution: Cardiff University - ORCA Online Research @Cardiff

collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research

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

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

location_facility: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust


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

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

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

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


lead_sponsor: Regeneron Pharmaceuticals

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

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

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

location_facility: The University of Texas MD Anderson Cancer Center

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

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

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

location_country:
United States
United Kingdom
Korea, Republic of
France


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

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

ReferenceCitation: Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. doi: 10.1056/NEJMoa050522. Epub 2005 Mar 9.

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

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Bristol-Myers Squibb

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

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


title: A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

acronym: TROPIC

summary: This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

ReferenceCitation: Lorente D, Mateo J, Templeton AJ, Zafeiriou Z, Bianchini D, Ferraldeschi R, Bahl A, Shen L, Su Z, Sartor O, de Bono JS. Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use. Ann Oncol. 2015 Apr;26(4):750-755. doi: 10.1093/annonc/mdu587. Epub 2014 Dec 23.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Bahl A, Oudard S, Tombal B, Ozguroglu M, Hansen S, Kocak I, Gravis G, Devin J, Shen L, de Bono JS, Sartor AO; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Pouessel D, Oudard S, Gravis G, Priou F, Shen L, Culine S. [Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France]. Bull Cancer. 2012 Jul-Aug;99(7-8):731-41. doi: 10.1684/bdc.2012.1608. French.

ReferenceCitation: de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

location_country:
Finland
Germany
Argentina
Brazil
Turkey
Chile
Canada
France
Czech Republic
Slovakia
Hungary
Denmark
United States
India
Belgium
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden

location_facility:
sanofi-aventis Italy
sanofi-aventis Spain
sanofi-aventis Mexico
sanofi-aventis Taiwan
sanofi-aventis US
sanofi-aventis Denmark
sanofi-aventis Brazil
sanofi-aventis Chile
sanofi-aventis Czech Republic
sanofi-aventis Belgium
Sanofi-Aventis Hungaria
sanofi-aventis Germany
sanofi-aventis Slovakia
sanofi-aventis Canada
sanofi-aventis UK
sanofi-aventis Singapore
sanofi-aventis Netherlands
sanofi-aventis South Korea
sanofi-aventis Turkey
sanofi-aventis India
sanofi-aventis South Africa
sanofi-aventis Finland
sanofi-aventis Russia
sanofi-aventis Argentina
sanofi-aventis Sweden
sanofi-aventis France


title: International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity

acronym: EQUINOX

summary:
The three purposes of this study are the following:

To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

ReferenceCitation: Equinox Investigators. Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis. J Thromb Haemost. 2011 Jan;9(1):92-9. doi: 10.1111/j.1538-7836.2010.04100.x.

ReferenceCitation: Trellu M, Fau JB, Cortez P, Cheng S, Paty I, Boelle E, Donat F, Sanderink GJ. Bioequipotency of idraparinux and idrabiotaparinux after once weekly dosing in healthy volunteers and patients treated for acute deep vein thrombosis. Br J Clin Pharmacol. 2013 May;75(5):1255-64. doi: 10.1111/bcp.12009.

ReferenceCitation: Paty I, Trellu M, Destors JM, Cortez P, Boelle E, Sanderink G. Reversibility of the anti-FXa activity of idrabiotaparinux (biotinylated idraparinux) by intravenous avidin infusion. J Thromb Haemost. 2010 Apr;8(4):722-9. doi: 10.1111/j.1538-7836.2010.03746.x. Epub 2010 Jan 17.

location_country:
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Canada
France
Czech Republic
Denmark
United States
Belgium
Italy
Netherlands
Austria
Mexico
Spain
South Africa
Russian Federation
Israel

location_facility:
Sanofi-Aventis
sanofi-aventis Israel
sanofi-aventis Mexico
sanofi-aventis, Netherlands
Sanofi-aventis
sanofi-aventis Turkey
sanofi-aventis France


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses

acronym: TEMSO

summary:
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue;
to evaluate the safety and tolerability of teriflunomide.

ReferenceCitation: O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303. doi: 10.1056/NEJMoa1014656.

ReferenceCitation: Sprenger T, Kappos L, Sormani MP, Miller AE, Poole EM, Cavalier S, Wuerfel J. Effects of teriflunomide treatment on cognitive performance and brain volume in patients with relapsing multiple sclerosis: Post hoc analysis of the TEMSO core and extension studies. Mult Scler. 2022 Oct;28(11):1719-1728. doi: 10.1177/13524585221089534. Epub 2022 Apr 29.

publisher_dissemination: SAGE Publications

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

repository_institution: University of Ottawa - uO Research

repositories_concat: PubMed Central;ruor.uottawa.ca

ReferenceCitation: Radue EW, Sprenger T, Gaetano L, Mueller-Lenke N, Cavalier S, Thangavelu K, Panzara MA, Donaldson JE, Woodward FM, Wuerfel J, Wolinsky JS, Kappos L. Teriflunomide slows BVL in relapsing MS: A reanalysis of the TEMSO MRI data set using SIENA. Neurol Neuroimmunol Neuroinflamm. 2017 Aug 9;4(5):e390. doi: 10.1212/NXI.0000000000000390. eCollection 2017 Sep.

ReferenceCitation: Sormani MP, Truffinet P, Thangavelu K, Rufi P, Simonson C, De Stefano N. Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e379. doi: 10.1212/NXI.0000000000000379. eCollection 2017 Sep.

ReferenceCitation: Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.

ReferenceCitation: Miller AE, O'Connor P, Wolinsky JS, Confavreux C, Kappos L, Olsson TP, Truffinet P, Wang L, D'Castro L, Comi G, Freedman MS; Teriflunomide Multiple Sclerosis Trial Group. Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis. Mult Scler. 2012 Nov;18(11):1625-32. doi: 10.1177/1352458512450354. Epub 2012 Jun 21.

location_country:
Finland
Germany
Poland
Turkey
Chile
Canada
France
Czech Republic
Portugal
Denmark
Switzerland
United States
Ukraine
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Russian Federation
Sweden

location_facility:
Sanofi-Aventis
Sanofi-Aventis Deutschland GmbH
Sanofi-Aventis Switzerland
sanofi-aventis Denmark
sanofi-aventis Turkey
sanofi-aventis Finland
Sanofi-Aventis Austria
sanofi-aventis UK
sanofi-aventis Poland
Sanofi-Aventis Administrative Office
sanofi-aventis, Canada
sanofi-aventis France


title: A Randomized Dose Ranging Study of Hexadecasaccharide Including Active Control, in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention (SHINE)

acronym: SHINE

summary: The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.

location_country:
France
Poland
India
Portugal
Argentina
Australia
Brazil
Netherlands
Mexico
Belgium
United States
Korea, Republic of
Spain
Turkey
Chile
Canada
Russian Federation
Czech Republic

location_facility:
Sanofi-Aventis
Sanofi-Aventis France
Sanofi-aventis


title: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

acronym: LIVACOR

summary: The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

ReferenceCitation: van der Poel MJ, Tanis PJ, Marsman HA, Rijken AM, Gertsen EC, Ovaere S, Gerhards MF, Besselink MG, D'Hondt M, Gobardhan PD. Laparoscopic combined resection of liver metastases and colorectal cancer: a multicenter, case-matched study using propensity scores. Surg Endosc. 2019 Apr;33(4):1124-1130. doi: 10.1007/s00464-018-6371-1. Epub 2018 Aug 1.

ReferenceCitation: Pan L, Tong C, Fu S, Fang J, Gu Q, Wang S, Jiang Z, Juengpanich S, Cai X. Laparoscopic procedure is associated with lower morbidity for simultaneous resection of colorectal cancer and liver metastases: an updated meta-analysis. World J Surg Oncol. 2020 Sep 21;18(1):251. doi: 10.1186/s12957-020-02018-z.

ReferenceCitation: Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Metairie S, Paye F, Bourlier P, Adam R, Merdrignac A, Tual C, Le Pabic E, Sulpice L, Meunier B, Regimbeau JM, Bellissant E; METASYNC Study group. Simultaneous Versus Delayed Resection for Initially Resectable Synchronous Colorectal Cancer Liver Metastases: A Prospective, Open-label, Randomized, Controlled Trial. Ann Surg. 2021 Jan 1;273(1):49-56. doi: 10.1097/SLA.0000000000003848.

ReferenceCitation: Gavriilidis P, Sutcliffe RP, Hodson J, Marudanayagam R, Isaac J, Azoulay D, Roberts KJ. Simultaneous versus delayed hepatectomy for synchronous colorectal liver metastases: a systematic review and meta-analysis. HPB (Oxford). 2018 Jan;20(1):11-19. doi: 10.1016/j.hpb.2017.08.008. Epub 2017 Sep 7.

lead_sponsor: Fondazione Poliambulanza Istituto Ospedaliero

collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

collaborators: University Hospital Southampton NHS Foundation Trust

collaborators: University Hospital Birmingham NHS Foundation Trust

collaborators: Liverpool University Hospitals NHS Foundation Trust

collaborators: Manchester University NHS Foundation Trust

collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

collaborators: Azienda Ospedaliero-Universitaria di Modena

collaborators: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

collaborators: University of Navarrra Hospital (Clinica Universitaria)

location_country:
Germany
Italy
Norway
United Kingdom
Netherlands
Belgium
Spain
Luxembourg
Russian Federation
France


title: Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation

acronym: ISMV

summary:
The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units:

Main analysis: To know the all-cause mortality rate in mechanically ventilated patients

Secondary analyses:

To know the current status of mechanical ventilation in the intensive care unit and determine the number and percentage of patients who are admitted to an intensive care unit and require mechanical ventilation.
To compare the results with prior data collected in previous observational studies (1998 and 2004)
Non-invasive positive pressure ventilation
Weaning
Use of adjuvant therapies as steroids or selective digestive decontamination
Sedation including prevalence of delirium in mechanically ventilated patients
Prediction of the duration of mechanical ventilation
Other

ReferenceCitation: Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

ReferenceCitation: Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.

ReferenceCitation: Nin N, Muriel A, Penuelas O, Brochard L, Lorente JA, Ferguson ND, Raymondos K, Rios F, Violi DA, Thille AW, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Soto L, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A, Sznajder JI, Esteban A; VENTILA Group. Severe hypercapnia and outcome of mechanically ventilated patients with moderate or severe acute respiratory distress syndrome. Intensive Care Med. 2017 Feb;43(2):200-208. doi: 10.1007/s00134-016-4611-1. Epub 2017 Jan 20.

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories:
PubMed Central
dnet
repositorio.chlc.min-saude.pt

ReferenceCitation: Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.

publisher_dissemination: American Thoracic Society

lead_sponsor: Hospital Universitario Getafe

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Vietnam
Turkey
Chile
Canada
France
Colombia
Portugal
Hungary
Denmark
United States
Morocco
India
Tunisia
China
Peru
Puerto Rico
Egypt
Italy
Ecuador
Venezuela
Netherlands
Mexico
Bolivia
Korea, Republic of
Saudi Arabia
Spain
Uruguay
Greece
Panama
Taiwan
Russian Federation

location_facility: Fondazione IRCCS Policlinico "S. Matteo", Università Di Pavia (ICU 1 & ICU 2)

location_facility: Ospedale Maggiore Della Carità, Università Del Piemonte Orientale "Amedeo Avogadro"

location_facility: National Institute Of Surgery Named After A.V. Vishnevskij

location_facility: Policlinico "Umberto I", Università La Sapienza

location_facility: Hôpital Militaire D'Instruction Mohamed V

location_facility: University Of Texas Medical Branch at Galveston

location_facility: Hospital Fattouma Bourguina (ICU medical & ICU surgical)

location_facility: Calcutta medical research institute (CMRI)

location_facility: Fondazione IRCCS "Cà Grande" Ospedale Maggiore Policlinico, Università Di Milano

location_facility: Universitaetsklinikum der Martin-Luther-Universitaet Halle-Wittenberg

location_facility: Clínica Privada de Especialidades de Villa María

location_facility: Samsung Medical Center, Sungkyunkwan University

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Vanderbilt University School Of Medicine

location_facility: Centre Hospitalier de Châlons en Champagne

location_facility: Hospital Interzonal General de Agudo Profesor Dr .Luis Guemes

location_facility: Hospital Chuncheon Sacred Heart Hospital, Hallym University Medical Center

location_facility: Hospital de Pronto Socorro Risoleta Tolentino Neves

location_facility: Staedtisches Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Chongqing Medical University 1st Hospital

location_facility: Hospital Interzonal de Agudos San Martin

location_facility: Centro Hospitalar Do Porto - Hospital Geral De Santo António

location_facility: Oklahoma University Health Science Center & VA medical Center

location_facility: Universitaetsklinikum Bonn (ICU medical-surgical & ICU surgical)

location_facility: Policlinico Universitario "S. Orsola-Malpighi"

location_facility: Fundación Hospital Universitario de Alcorcón

location_facility: Ospedale "San Gerardo", Università Di Milano Bicocca

location_facility: Clínica Medellín & Universidad Pontificia Bolivariana

location_facility: University of Louisville School of Medicine

location_facility: Ospedale "San Giovanni Battista - Molinette", Università Di Torino

location_facility: Hospital Clinic-IDIBAPS (ICU medical & ICU respiratory)

location_facility: King Saud Bin Abdulaziz University for Health Sciences

location_facility: Katholische Stiftung Marienhospital Aachen

location_facility: Hospital Universitário da Universidade Federal de Juiz de Fora

location_facility: Hospital Universitario Doctor Josep Trueta

location_facility: Instituto Nacional De Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Hospital General de Agudos donación Francisco Santojanni

location_facility: Evangelisches Waldkrankenhaus Bad Godesberg gGmbH

location_facility: Hospital Universitario de Nuevo León 'Dr. Eleuterio González'

location_facility: Bombay Hospital Institute of Medical Sciences

location_facility: Grupo Cimca Hospital de San José (medical ICU)

location_facility: Asan Medical Center, University of Ulsan

location_facility: Hospital Universitario, Universidad Abierta Interamericana

location_facility: Instituto Português de Oncología Francisco Gentil

location_facility: Ospedale Policlinico "Federico II", Università Di Napoli

location_facility: Hospital de SOLCA (ICU medical surgical & ICU medical)

location_facility: Hospital Severance, Yonsei University Health System

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Complejo Hospitalario de Santiago de Compostela

location_facility: Hospital General de Agudos Bernardino Rivadavia

location_facility: University of Iowa Hospitals and Clinics

location_facility: Medical Faculty of Yuzuncu Yil University

location_facility: University Hospital San Antonio and South Texas Veterans Health Care System

location_facility: Hospital Yonsei University Wonju Christian

location_facility: Charité Universitaetsklinikum (ICU medical-surgical & ICU other)

location_facility: Hospital de Santo Antonio dos Capuchos, Centro Hospitalar de Lisboa Central, E.P.E.

location_facility: Santa Casa de Misericórdia de Ouro Preto

location_facility: Policlinico "Agostino Gemelli", Università Cattolica Del Sacro Cuore

location_facility: Centro Hospitalar Trás-Os-Montes E Alto Douro

location_facility: Vrije Universiteit Medisch Centrum (VUMC) (Three units)

location_facility: Evangelisches Krankenhaus Elisabethenstift gGmbH

location_facility: Policlinico "P. Giaccone", Università Di Palermo

location_facility: Hospital Pusan National University of Yangsan

location_facility: Hospital Regional de Alta Especialidad de la Mujer

location_facility: Hospital General de Agudos Dalmacio Vélez Sársfield

location_facility: Ospedale "Arnas Civico, Di Cristina, Benfratelli"

location_facility: Hospital General de Agudos Juan A. Fernandez

location_facility: Ospedale Policlinico, Università Di Bari

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Umae Hospital De Especialidades Dr. Antonio Fraga Mouret

location_facility: Karol Marcinkowski University Of Medical Sciences

location_facility: Ermstalklinik Staedtisches Krankenhaus Sindelfingen

location_facility: Hospital General de Jerez de la Frontera