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9 p, 536.9 KB |
Comparison of the efficacy and safety of FP-1201-lyo (intravenously administered recombinant human interferon beta-1a) and placebo in the treatment of patients with moderate or severe acute respiratory distress syndrome : Study protocol for a randomized controlled trial
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Bellingan, Geoff (University College London Hospitals) ;
Brealey, David (University College London Hospitals) ;
Mancebo, Jordi (Institut d'Investigació Biomèdica Sant Pau) ;
Mercat, Alain (CHU D'Angers) ;
Patroniti, Nicolò (Azienda Ospedaliera San Gerardo) ;
Pettilä, Ville (Helsinki University Hospital) ;
Quintel, Michael (Universitätsmedizin Göttingen) ;
Vincent, Jean-Louis (Université libre de Bruxelles) ;
Maksimow, Mikael (Faron Pharmaceuticals Oy) ;
Jalkanen, Markku (Faron Pharmaceuticals Oy) ;
Piippo, Ilse (Faron Pharmaceuticals Oy) ;
Ranieri, V.Marco (Sapienza University of Rome) ;
Universitat Autònoma de Barcelona
Acute respiratory distress syndrome (ARDS) results in vascular leakage, inflammation and respiratory failure. There are currently no approved pharmacological treatments for ARDS and standard of care involves treatment of the underlying cause, and supportive care. [...]
2017 -  10.1186/s13063-017-2234-7
Trials, Vol. 18 Núm. 1 (13 2017) , p. 536
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10 p, 1.2 MB |
Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial) : Study protocol for a randomized controlled trial
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Funcke, Sandra (University Medical Center Hamburg-Eppendorf) ;
Saugel, Bernd (University Medical Center Hamburg-Eppendorf) ;
Koch, Christian (Universitätsklinikum Giessen und Marburg GmbH) ;
Schulte, Dagmar (Universitätsklinikum Giessen und Marburg GmbH) ;
Zajonz, Thomas (Universitätsklinikum Giessen und Marburg GmbH) ;
Sander, Michael (Universitätsklinikum Giessen und Marburg GmbH) ;
Gratarola, Angelo (Università degli Studi di Genova) ;
Ball, Lorenzo (Università degli Studi di Genova) ;
Pelosi, Paolo (Università degli Studi di Genova) ;
Spadaro, Savino (University of Ferrara) ;
Ragazzi, Riccardo (University of Ferrara) ;
Volta, Carlo Alberto (University of Ferrara) ;
Mencke, Thomas (University of Rostock) ;
Zitzmann, Amelie (University of Rostock) ;
Neukirch, Benedikt (University of Rostock) ;
Azparren Cabezón, Gonzalo (Institut d'Investigació Biomèdica Sant Pau) ;
Gine Serven, Marta (Institut d'Investigació Biomèdica Sant Pau) ;
Moral, Victoria (Institut d'Investigació Biomèdica Sant Pau) ;
Pinnschmidt, Hans Otto (University Medical Center Hamburg-Eppendorf) ;
Diaz-Cambronero, Oscar (Instituto de Investigación Sanitaria La Fe (IIS laFe)) ;
Estelles, Maria Jose Alberola (Instituto de Investigación Sanitaria La Fe (IIS laFe)) ;
Velez, Marisol Echevarri (Instituto de Investigación Sanitaria La Fe (IIS laFe)) ;
Montañes, Maria Vila (Instituto de Investigación Sanitaria La Fe (IIS laFe)) ;
Belda, Javier (Hospital Clínic Universitari (València)) ;
Soro, Marina (Hospital Clínic Universitari (València)) ;
Puig, Jaume (Hospital Clínic Universitari (València)) ;
Reuter, Daniel Arnulf (University of Rostock) ;
Haas, Sebastian Alois (University of Rostock) ;
Universitat Autònoma de Barcelona
Postoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac output optimization is able to reduce mortality and postoperative moderate and severe complications as a major determinant of the patients' postoperative quality of life, as well as health care costs. [...]
2018 - 10.1186/s13063-018-2620-9
Trials, Vol. 19 Núm. 1 (september 2018) , p. 273
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10 p, 590.7 KB |
Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS : A randomized controlled trial protocol
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Gornals, Joan B. (Hospital Universitari de Bellvitge) ;
Perez-Miranda, Manuel (Hospital Universitario Río Hortega (Valladolid)) ;
Vazquez-Sequeiros, Enrique (Hospital Universitario Ramón y Cajal (Madrid)) ;
Vila, Juan (Complejo Hospitalario de Navarra) ;
Esteban, José M. (Hospital Clínico San Carlos (Madrid)) ;
Gonzalez-Huix, Ferran (Hospital Arnau de Vilanova (València)) ;
Guarner-Argente, Carlos (Institut d'Investigació Biomèdica Sant Pau) ;
Sanchez-Yague, Andres (Hospital Costa Del Sol) ;
Teran, Alvaro (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria)) ;
Bas-Cutrina, Francesc (Hospital Universitari de Bellvitge) ;
De La Serna, Carlos (Hospital Universitario Río Hortega (Valladolid)) ;
De Paredes, Ana Garcia (Hospital Universitario Ramón y Cajal (Madrid)) ;
Ballester, Raquel (Hospital Arnau de Vilanova (València)) ;
Velasquez-Rodriguez, Julio (Hospital Universitari de Bellvitge) ;
Salord, Silvia (Hospital Universitari de Bellvitge) ;
Tebé, Cristian (Hospital Universitari de Bellvitge) ;
Hereu, Pilar (Hospital Universitari de Bellvitge) ;
Videla, Sebastián (Hospital Universitari de Bellvitge) ;
Universitat Autònoma de Barcelona
It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. [...]
2019 - 10.1186/s13063-019-3988-x
Trials, Vol. 20 Núm. 1 (30 2019) , p. 791
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12 p, 1.3 MB |
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3) : a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
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Marcucci, Maura (Population Health Research Institute) ;
Painter, Thomas W. (Department of Anaesthesia. Royal Adelaide Hospital) ;
Conen, David (Population Health Research Institute) ;
Leslie, Kate (Department of Critical Care Medicine. Melbourne Medical School. University of Melbourne) ;
Lomivorotov, Vladimir V. (Department of Anesthesiology and Intensive Care. Novosibirsk State University) ;
Sessler, Daniel (Department of Outcomes Research. Anesthesiology Institute. Cleveland Clinic) ;
Chan, Matthew T.V. (The Chinese University of Hong Kong) ;
Borges, Flavia K. (Population Health Research Institute) ;
Martinez-Zapata, Maria José (Institut d'Investigació Biomèdica Sant Pau) ;
Wang, C.Y. (Department of Anaesthesiology. Faculty of Medicine. University of Malaya) ;
Xavier, Denis (St. John's Medical College) ;
Ofori, Sandra N. (Population Health Research Institute) ;
Landoni, G. (School of Medicine. Vita-Salute San Raffaele University) ;
Efremov, S. (Saint Petersburg State University Hospital) ;
Kleinlugtenbelt, Y.V. (Department of Orthopedic and Trauma Surgery. Deventer Ziekenhuis) ;
Szczeklik, W. (Jagiellonian University Medical College. Center for Intensive Care and Perioperative Medicine) ;
Schmartz, D. (CHU Brugmann. Université libre de Bruxelles) ;
Garg, A. X. (Department of Medicine. Epidemiology and Biostatistics. Western University) ;
Short, T.G. (University of Auckland. School of Health Sciences) ;
Wittmann, M. (Department of Anesthesiology. University Hospital) ;
Meyhoff, C.S. (Department of Anaesthesia and Intensive Care. Bispebjerg and Frederiksberg Hospital. University of Copenhagen) ;
Amir, Mohammed (Shifa International Hospital (STMU)) ;
Torres, D. (Universidad de Los Andes) ;
Patel, A. (Department of Medicine. McMaster University) ;
Duceppe, E. (Department of Medicine. Universite de Montreal) ;
Ruetzler, K. (Department of Outcomes Research. Anesthesiology Institute. Cleveland Clinic) ;
Parlow, Joel (Department of Anesthesiology and Perioperative Medicine. Kingston General Hospital and Queen's University) ;
Tandon, V. (Department of Medicine. McMaster University) ;
Wang, M.K. (Population Health Research Institute) ;
Fleischmann, E. (Department of Anesthesia. General Intensive Care and Pain Management. Medical University of Vienna) ;
Polanczyk, C.A. (Cardiology Department. Hospital de Clínicas de Porto Alegre) ;
Jayaram, R. (Nuffield Department of Anaesthetics. Clinical Neurosciences. University of Oxford) ;
Astrakov, S.V. (Department of Anesthesiology. Novosibirsk State University) ;
Rao, M. (St. John's Medical College) ;
VanHelder, T. (Department of Anesthesia. McMaster University) ;
Wu, W.K.K. (The Chinese University of Hong Kong) ;
Cheong, C.C. (Department of Anaesthesiology. Faculty of Medicine. University of Malaya) ;
Ayad, S. (Case Western Reserve University. Anesthesiology Institute. Cleveland Clinic - Fairview Hospital) ;
Abubakirov, M. (Meshalkin National Medical Research Center) ;
Kirov, M. (Department of Anesthesiology and Intensive Care Medicine. Northern State Medical University) ;
Bhatt, Keyur (SIDS Hospital & Research Centre) ;
de Nadal, M. (Hospital Universitari Vall d'Hebron) ;
Likhvantsev, V. (M. Vladimirskiy Moscow Regional Clinical and Research Institute) ;
Paniagua, Pilar (Institut d'Investigació Biomèdica Sant Pau) ;
Aguado, H.J. (Trauma & Orthopaedic surgery department. Hospital Clínico Universitario) ;
McGillion, M. (School of Nursing. McMaster University) ;
Lamy, A. (Department of Surgery. McMaster University) ;
Whitlock, R.P. (Department of Surgery. McMaster University) ;
Roshanov, P. (Department of Medicine. London Health Sciences Centre) ;
Stillo, D. (Population Health Research Institute) ;
Copland, I. (Population Health Research Institute) ;
Vincent, J. (Population Health Research Institute) ;
Balasubramanian, K. (Population Health Research Institute) ;
Bangdiwala, S.I. (Population Health Research Institute) ;
Biccard, Bruce M (Department of Anaesthesia and Perioperative Medicine. Groote Schuur Hospital and University of Cape Town) ;
Kurz, A. (Department of General Anaesthesiology. Emergency- and Intensive Care Medicine. Medical University Graz) ;
Srinathan, S. (Department of Surgery. University of Manitoba) ;
Petit, S. (Population Health Research Institute) ;
Eikelboom, J. (Population Health Research Institute) ;
Richards, T. (Faculty of Health and Medical Sciences. University of Western Australia) ;
Gross, P.L. (Department of Medicine. McMaster University) ;
Alfonsi, P. (Department of Anesthesiology. GH Paris Saint Joseph) ;
Guyatt, G. (Department of Medicine. McMaster University) ;
Belley-Cote, E. (Population Health Research Institute) ;
Spence, J. (Department of Anesthesia. McMaster University) ;
McIntyre, W. (Population Health Research Institute) ;
Yusuf, S. (Population Health Research Institute) ;
Devereaux, P. J (Population Health Research Institute)
Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. [...]
2022 - 10.1186/s13063-021-05992-1
Trials, Vol. 23 Núm. 1 (december 2022) , p. 101
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15 p, 1.3 MB |
Effectiveness of four deconstructive meditative practices on well-being and self-deconstruction : study protocol for an exploratory randomized controlled trial
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Garcia-Campayo, Javier (Universidad de Zaragoza. Departamento de Medicina, Psiquiatría y Dermatología) ;
Hijar-Aguinaga, Rinchen (Universidad de Zaragoza. Departamento de Medicina, Psiquiatría y Dermatología) ;
López-del-Hoyo, Yolanda (RedIAPP) ;
Magallón-Botaya, Rosa (Universidad de Zaragoza) ;
Fernández-Martínez, Selene (Instituto de Investigación Sanitaria de Aragón) ;
Barceló-Soler, Alberto (Instituto de Investigación Sanitaria de Aragón) ;
Soler, Joaquim (Institut de Recerca Sant Pau) ;
Montero-Marin, Jesus (CIBER) ;
Universitat Autònoma de Barcelona
The efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. [...]
2023 - 10.1186/s13063-023-07151-0
Trials, Vol. 24 (february 2023)
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8 p, 803.0 KB |
The effectiveness of a web-based decision aid for patients with hip osteoarthritis : Study protocol for a randomized controlled trial
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Perestelo-Pérez, Lilisbeth (Center for Biomedical Research of the Canary Islands) ;
Álvarez-Pérez, Yolanda (Fundación Canaria Instituto de Investigación Sanitaria de Canarias) ;
Rivero-Santana, Amado (Fundación Canaria Instituto de Investigación Sanitaria de Canarias) ;
Ramos-García, Vanesa (Fundación Canaria Instituto de Investigación Sanitaria de Canarias) ;
Duarte-Díaz, Andrea (Fundación Canaria Instituto de Investigación Sanitaria de Canarias) ;
Torres-Castaño, Alezandra (Fundación Canaria Instituto de Investigación Sanitaria de Canarias) ;
Toledo-Chávarri, Ana (Fundación Canaria Instituto de Investigación Sanitaria de Canarias) ;
Herrera-Perez, Mario (Hospital Universitario de Canarias (La Laguna)) ;
País-Brito, José Luis (Hospital Universitario de Canarias (La Laguna)) ;
Del Castillo, José Carlos (Hospital San Juan de Dios de Santa Cruz de Tenerife) ;
Vázquez, José Ramon (Gerencia de Atención Primaria de Tenerife Del Servicio Canario de la Salud) ;
Orrego, Carola (Universitat Autònoma de Barcelona. Institut Universitari Avedis Donabedian) ;
Serrano-Aguilar, Pedro (Center for Biomedical Research of the Canary Islands)
Background: Osteoarthritis (OA) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs, and preferences into the decision-making process, thus improving person-centered care. [...]
2020 - 10.1186/s13063-020-04661-z
Trials, Vol. 21 Núm. 1 (24 2020) , p. 736
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10 p, 800.2 KB |
Pre-exposure prophylaxis with hydroxychloroquine for COVID-19 : a double-blind, placebo-controlled randomized clinical trial
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Grau-Pujol, Berta (Institut de Salut Global de Barcelona) ;
Camprubí-Ferrer, D. (Institut de Salut Global de Barcelona) ;
Marti-Soler, H. (Institut de Salut Global de Barcelona) ;
Fernández-Pardos, M. (Institut de Salut Global de Barcelona) ;
Carreras-Abad, Clara (Institut de Salut Global de Barcelona) ;
Velasco de Andrés, María (Institut de Salut Global de Barcelona) ;
Ferrer, E. (Institut de Salut Global de Barcelona) ;
Muelas-Fernandez, M. (Institut de Salut Global de Barcelona) ;
Jullien, S. (Institut de Salut Global de Barcelona) ;
Barilaro, G. (Institut de Salut Global de Barcelona) ;
Ajanovic, S. (Institut de Salut Global de Barcelona) ;
Vera, I. (Institut de Salut Global de Barcelona) ;
Moreno, L. (Institut d'Investigacions Biomèdiques August Pi i Sunyer) ;
Gonzalez-Redondo, E. (Institut d'Investigacions Biomèdiques August Pi i Sunyer) ;
Cortés Serra, Núria (Institut de Salut Global de Barcelona) ;
Roldán, M. (Institut de Salut Global de Barcelona) ;
Arcos, A. A. d. (Institut de Salut Global de Barcelona) ;
Mur, Isabel (Institut d'Investigació Biomèdica Sant Pau) ;
Domingo, Pere (Institut d'Investigació Biomèdica Sant Pau) ;
Garcia, F. (Institut d'Investigacions Biomèdiques August Pi i Sunyer) ;
Guinovart, C. (Institut de Salut Global de Barcelona) ;
Muñoz, J. (Institut de Salut Global de Barcelona) ;
Universitat Autònoma de Barcelona
Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. [...]
2021 - 10.1186/s13063-021-05758-9
Trials, Vol. 22 Núm. 1 (december 2021) , p. 808
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14 p, 769.9 KB |
The SITLESS project : Exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: Study protocol for a randomised controlled trial
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Giné-Garriga, Maria (Universitat Ramon Llull) ;
Coll-Planas, Laura (Universitat Autònoma de Barcelona. Fundació Salut i Envelliment) ;
Guerra-Balic, Míriam (Universitat Ramon Llull) ;
Domingo, Àlex (Universitat Autònoma de Barcelona. Fundació Salut i Envelliment) ;
Roqué i Figuls, Marta (Universitat Autònoma de Barcelona. Fundació Salut i Envelliment) ;
Caserotti, Paolo (Syddansk Universitet) ;
Denkinger, Michael (Universität Ulm) ;
Rothenbacher, Dietrich (Universität Ulm) ;
Tully, Mark A. (Queen's University Belfast) ;
Kee, Frank (Queen's University Belfast) ;
McIntosh, Emma (University of Glasgow) ;
Martín-Borràs, Carme (Universitat Ramon Llull) ;
Oviedo, Guillermo R. (Universitat Ramon Llull) ;
Jerez-Roig, Javier (Universitat Ramon Llull) ;
Santiago, Marta (Universitat Ramon Llull) ;
Sansano, Oriol (Universitat Ramon Llull) ;
Varela, Guillermo (Universitat Ramon Llull) ;
Skjødt, Mathias (Syddansk Universitet) ;
Wirth, Katharina (Universität Ulm) ;
Dallmeier, Dhayana (Universität Ulm) ;
Klenk, Jochen (Universität Ulm) ;
Wilson, Jason J. (Queen's University Belfast) ;
Blackburn, Nicole E.. (Queen's University Belfast) ;
Deidda, Manuela (University of Glasgow) ;
Lefebvre, Guillaume (Sport Initiative et Loisir Bleu Association) ;
González, Denise (Sport Initiative et Loisir Bleu Association) ;
Salvà Casanovas, Antoni (Universitat Autònoma de Barcelona. Fundació Salut i Envelliment)
Background: Older adults are the fastest growing segment of the world's population. Recent evidence indicates that excessive sitting time is harmful to health, independent of meeting the recommended moderate to vigorous physical activity (PA) guidelines. [...]
2017 - 10.1186/s13063-017-1956-x
Trials, Vol. 18 Núm. 1 (5 2017) , p. 221
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8 p, 562.0 KB |
Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome : study protocol for a randomized controlled trial
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Carralero Martínez, Andrea (Hospital Clínic i Provincial de Barcelona) ;
Muoz Prez, M. A. (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i Medicina Preventiva i Salut Pública) ;
Pan-Alemany, R. (Rehabilitacin Abdomino-Pelviana (Barcelona)) ;
Blanco-Ratto, L. (Fundació Universitària del Bages) ;
Kauffmann, S. (Servicio de Fisioterapia, Womens Salud y Bienestar de la Mujer (Barcelona)) ;
Ramrez-Garca, I. (Universitat Internacional de Catalunya)
Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5. 7% to 26. 6% of women and 2. 2% to 9. 7% of men, characterized by hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. [...]
2021 - 10.1186/s13063-021-05321-6
Trials, Vol. 22 (may 2021)
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10 p, 855.3 KB |
The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients : study protocol for a randomised controlled trial
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Kingslake, Jonathan (P1vital Products Ltd, Howbery Park, Wallingford, Oxfordshire UK) ;
Dias, Rebecca (P1vital Products Ltd, Howbery Park, Wallingford, Oxfordshire UK) ;
Dawson, Gerard R. (P1vital Ltd., Howbery Park, Wallingford, Oxfordshire UK) ;
Simon, Judit (University of Oxford) ;
Goodwin, Guy M. (Oxford Health NHS Trust, Oxford) ;
Harmer, Catherine J. (University of Oxford) ;
Morriss, Richard (University of Nottingham) ;
Brown, Susan (University of Nottingham) ;
Guo, Boliang (University of Nottingham) ;
Dourish, Colin T. (P1vital Ltd., Howbery Park, Wallingford, Oxfordshire UK) ;
Ruhé, Henricus G. (University of Groningen) ;
Lever, Anne G. (VU University Medical Centre and Amsterdam Neuroscience) ;
Veltman, Dick J. (VU University Medical Centre and Amsterdam Neuroscience) ;
van Schaik, Anneke (VU University Medical Centre and Amsterdam Neuroscience) ;
Deckert, Jürgen (University Hospital of Würzburg) ;
Reif, Andreas (University Hospital of Frankfurt (Alemanya)) ;
Stäblein, Michael (University Hospital of Frankfurt (Alemanya)) ;
Menke, Andreas (University Hospital of Würzburg) ;
Gorwood, Philip (Université Paris-Descartes) ;
Voegeli, Géraldine (Université Paris-Descartes) ;
Pérez Solà, Víctor (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal) ;
Browning, Michael (Oxford Health NHS Trust, Oxford, UK)
Antidepressant medication is commonly used to treat depression. However, many patients do not respond to the first medication prescribed and improvements in symptoms are generally only detectable by clinicians 4-6 weeks after the medication has been initiated. [...]
2017 - 10.1186/s13063-017-2247-2
Trials, Vol. 18 (november 2017)
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