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Clinical translation

Section edited by Lana Kandalaft

This section aims to allow rapid communication of innovative early phase clinical trials, where novel scientific ideas are translated to the clinic. These include clinical trials that are distinguished for their novelty in approach, design or indication, timeliness, and unique ability to translate laboratory concepts from the bench to the bedside. Manuscripts are submitted typically at the time a clinical trial has gained full regulatory approval and is being initiated. No clinical results are required. These articles review the background, rationale, clinical design and approach, translational endpoints and expected outcomes of a new clinical trial in a scholarly manner, and provide the opportunity to investigators to share their views and clinical translation efforts with a wide audience at an early stage.

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  1. Content type: Research

    Patients with hereditary diffuse gastric cancer (HDGC), a cancer predisposition syndrome associated with germline mutations of the CDH1 (E-cadherin) gene, have few effective treatment options. Despite marked d...

    Authors: Ina Chen, Lesley Mathews-Greiner, Dandan Li, Abisola Abisoye-Ogunniyan, Satyajit Ray, Yansong Bian, Vivek Shukla, Xiaohu Zhang, Raj Guha, Craig Thomas, Berkley Gryder, Athina Zacharia, Joal D. Beane, Sarangan Ravichandran, Marc Ferrer and Udo Rudloff

    Citation: Journal of Translational Medicine 2017 15:92

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  2. Content type: Research

    Immunohistochemistry (IHC) and fluorescent-in situ hybridization (FISH) are standard methods to assess human epidermal growth factor receptor 2 (HER2) status in breast cancer (BC) patients. Real-time quantitat...

    Authors: Gabriele Zoppoli, Anna Garuti, Gabriella Cirmena, Ludovica Verdun di Cantogno, Cristina Botta, Maurizio Gallo, Domenico Ferraioli, Enrico Carminati, Paola Baccini, Monica Curto, Piero Fregatti, Edoardo Isnaldi, Michela Lia, Roberto Murialdo, Daniele Friedman, Anna Sapino…

    Citation: Journal of Translational Medicine 2017 15:91

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  3. Content type: Research

    TREM-1 acts as an amplifier of inflammation expressed on macrophages. The objective of this study was to evaluate the relationship between TREM-1 and macrophage polarization, and association of TREM-1 and M1 m...

    Authors: Saravanan Subramanian, Pradeep K. Pallati, Poonam Sharma, Devendra K. Agrawal and Kalyana C. Nandipati

    Citation: Journal of Translational Medicine 2017 15:85

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  4. Content type: Research

    Oxylipins are potent lipid mediators demonstrated to initiate and regulate inflammation yet little is known regarding their involvement in the response to surgical trauma. As key modulators of the inflammatory...

    Authors: Arnaud M. Wolfer, Alasdair J. Scott, Claudia Rueb, Mathieu Gaudin, Ara Darzi, Jeremy K. Nicholson, Elaine Holmes and James M. Kinross

    Citation: Journal of Translational Medicine 2017 15:83

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  5. Content type: Research

    The O 6 -methylguanine methyltransferase (MGMT) gene is frequently unmethylated in patients with glioblastoma (GBM), rendering them non-responsive...

    Authors: Toni Rose Jue, Kyoko Nozue, Ashleigh J. Lester, Swapna Joshi, Lisette B. W. Schroder, Shane P. Whittaker, Sheri Nixdorf, Robert W. Rapkins, Mustafa Khasraw and Kerrie L. McDonald

    Citation: Journal of Translational Medicine 2017 15:61

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  6. Content type: Research

    Malignant mesothelioma (MM) is a very aggressive type of cancer, with a dismal prognosis and inherent resistance to chemotherapeutics. Development and evaluation of new therapeutic approaches is highly needed....

    Authors: Agata Szymiczek, Sandra Pastorino, David Larson, Mika Tanji, Laura Pellegrini, Jiaming Xue, Shuangjing Li, Carlotta Giorgi, Paolo Pinton, Yasutaka Takinishi, Harvey I. Pass, Hideki Furuya, Giovanni Gaudino, Andrea Napolitano, Michele Carbone and Haining Yang

    Citation: Journal of Translational Medicine 2017 15:58

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  7. Content type: Research

    Gastric cancer (GC) is one of the most malignant tumors and the second leading cause of cancer-related deaths in the world. Luteolin, a flavonoid present in many fruits and green plants, suppresses cancer prog...

    Authors: Ming-de Zang, Lei Hu, Zhi-yuan Fan, He-xiao Wang, Zheng-lun Zhu, Shu Cao, Xiong-yan Wu, Jian-fang Li, Li-ping Su, Chen Li, Zheng-gang Zhu, Min Yan and Bing-ya Liu

    Citation: Journal of Translational Medicine 2017 15:52

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  8. Content type: Research

    The purpose of the present study was to develop an animal model for creating alveolar cleft defects with properly simulated clinical defect environment for tissue-engineered bone-substitute materials testing w...

    Authors: Mohammad Kamal, Lars Andersson, Rene Tolba, Alexander Bartella, Felix Gremse, Frank Hölzle, Peter Kessler and Bernd Lethaus

    Citation: Journal of Translational Medicine 2017 15:50

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  9. Content type: Methodology

    Operational tolerance is an alternative to lifelong immunosuppression after transplantation. One strategy to achieve tolerance is by T regulatory cells. Safety and feasibility of a T regulatory type 1 (Tr1)-ce...

    Authors: Bechara Mfarrej, Eleonora Tresoldi, Angela Stabilini, Alessia Paganelli, Rossana Caldara, Antonio Secchi and Manuela Battaglia

    Citation: Journal of Translational Medicine 2017 15:40

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  10. Content type: Research

    Macrophages (Mφs) constitute a major component of the leukocyte infiltrate and perform distinct roles in different tumor microenvironments. This study aimed to characterize the distribution, composition and pr...

    Authors: Jin-Qing Li, Xing-Juan Yu, Yong-Chun Wang, Li-Yun Huang, Chao-Qun Liu, Limin Zheng, Yu-jing Fang and Jing Xu

    Citation: Journal of Translational Medicine 2017 15:37

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  11. Content type: Methodology

    Pathologic lymph node staging is becoming a deficient method in the demanding molecular era. Nevertheless, the use of more sensitive molecular analysis for nodal staging is hampered by its high costs and exte...

    Authors: Natalia Rakislova, Carla Montironi, Iban Aldecoa, Eva Fernandez, Josep Antoni Bombi, Mireya Jimeno, Francesc Balaguer, Maria Pellise, Antoni Castells and Miriam Cuatrecasas

    Citation: Journal of Translational Medicine 2017 15:14

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  12. Content type: Research

    Kidney transplantation is the most effective treatment for end-stage renal disease. Sensitization refers to pre-existing antibodies against human leukocyte antigen (HLA) protein and remains a major barrier to ...

    Authors: John F. Beausang, H. Christina Fan, Rene Sit, Maria U. Hutchins, Kshama Jirage, Rachael Curtis, Edward Hutchins, Stephen R. Quake and Julie M. Yabu

    Citation: Journal of Translational Medicine 2017 15:9

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  13. Content type: Methodology

    Rare nucleated CD45 negative cells in peripheral blood may be malignant such as circulating tumor cells. Untouched isolation thereof by depletion of normal is favored yet still technological challenging. We op...

    Authors: Stefan Schreier, Piamsiri Sawaisorn, Rachanee Udomsangpetch and Wannapong Triampo

    Citation: Journal of Translational Medicine 2017 15:6

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  14. Content type: Research

    Certain disadvantages of the standard hematopoietic stem and progenitor cell (HSPC) mobilizing agent G-CSF fuel the quest for alternatives. We herein report results of a Phase I dose escalation trial comparing...

    Authors: Darja Karpova, Susanne Bräuninger, Eliza Wiercinska, Ariane Krämer, Belinda Stock, Jochen Graff, Hans Martin, Achim Wach, Christophe Escot, Garry Douglas, Barbara Romagnoli, Eric Chevalier, Klaus Dembowski, Leon Hooftman and Halvard Bonig

    Citation: Journal of Translational Medicine 2017 15:2

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  15. Content type: Research

    Mantle cell lymphoma (MCL) is considered an aggressive subtype of non-Hodgkin’s lymphoma with variable treatment responses. There is an urgent need to identify novel markers with prognostic and therapeutic val...

    Authors: Xin Wang, Lalit Sehgal, Neeraj Jain, Tamer Khashab, Rohit Mathur and Felipe Samaniego

    Citation: Journal of Translational Medicine 2016 14:346

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  16. Content type: Commentary

    End goal of translational medicine is to combine disciplines and expertise to eventually promote improvement of the global healthcare system by delivering effective therapies to individuals and society. Well-t...

    Authors: Alessandra Petrelli, Berent J. Prakken and Norman D. Rosenblum

    Citation: Journal of Translational Medicine 2016 14:329

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  17. Content type: Research

    Local implantation of ex vivo concentrated, washed and filtrated human bone marrow-derived mononuclear cells (BMC) seeded onto β-tricalciumphosphate (TCP) significantly enhanced bone healing in a preclinical s...

    Authors: Caroline Seebach, Dirk Henrich, Simon Meier, Christoph Nau, Halvard Bonig and Ingo Marzi

    Citation: Journal of Translational Medicine 2016 14:314

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  18. Content type: Research

    The pre-treatment with α-tocopherol inhibits progression of rat liver proliferation induced by partial hepatectomy (PH), by decreasing and/or desynchronizing cyclin D1 expression and activation into the nucleu...

    Authors: Lourdes Sánchez-Sevilla, Edgar Mendieta-Condado and Rolando Hernández-Muñoz

    Citation: Journal of Translational Medicine 2016 14:307

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  19. Content type: Research

    Mechanical ventilation (MV) during a cardio-thoracic surgery contributes to diaphragm muscle dysfunction that impairs weaning and can lead to the ventilator- induced diaphragm dysfunction. Especially, it is cr...

    Authors: Robert T. Mankowski, Shakeel Ahmed, Thomas Beaver, Marvin Dirain, Chul Han, Phillip Hess, Tomas Martin, Barbara K. Smith, Shinichi Someya, Christiaan Leeuwenburgh and A. Daniel Martin

    Citation: Journal of Translational Medicine 2016 14:305

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  20. Content type: Research

    Certain glomerulopathies are associated with increased levels of CD80 (B7-1). We measured the urinary excretion of CD80, podocyturia and proteinuria in controls and in subjects with Fabry disease either untrea...

    Authors: H. Trimarchi, R. Canzonieri, A. Schiel, C. Costales-Collaguazo, J. Politei, A. Stern, M. Paulero, T. Rengel, J. Andrews, M. Forrester, M. Lombi, V. Pomeranz, R. Iriarte, A. Muryan, E. Zotta, M. D. Sanchez-Niño…

    Citation: Journal of Translational Medicine 2016 14:289

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  21. Content type: Research

    Patients with lower extremity peripheral artery disease (PAD) have decreased mobility, which is not fully explained by impaired blood supply to the lower limb. Additionally, reports are conflicted regarding fi...

    Authors: Sarah H. White, Mary M. McDermott, Robert L. Sufit, Kate Kosmac, Alex W. Bugg, Marta Gonzalez-Freire, Luigi Ferrucci, Lu Tian, Lihui Zhao, Ying Gao, Melina R. Kibbe, Michael H. Criqui, Christiaan Leeuwenburgh and Charlotte A. Peterson

    Citation: Journal of Translational Medicine 2016 14:284

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    The Erratum to this article has been published in Journal of Translational Medicine 2017 15:45

  22. Content type: Research

    Ischemia reperfusion injury (IRI) induced immune response is a critical issue in transplantation. Complement and contact system activation are among its key mechanisms.

    Authors: Pierre-Olivier Delpech, Raphael Thuillier, Thibault SaintYves, Jerome Danion, Sylvain Le Pape, Edwin S. van Amersfoort, Beatrijs Oortwijn, Gilles Blancho and Thierry Hauet

    Citation: Journal of Translational Medicine 2016 14:277

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  23. Content type: Research

    Chronic myelogenous leukemia (CML) is a hematological stem cell disorder. Tyrosine kinase inhibitors (TKIs) are the standard treatments for CML, but a number of patients fail to respond effectively due to gene...

    Authors: Ying Lu, Ling-Ling Liu, Shou-Sheng Liu, Zhi-Gang Fang, Yong Zou, Xu-Bin Deng, Zi-Jie Long, Quentin Liu and Dong-Jun Lin

    Citation: Journal of Translational Medicine 2016 14:270

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  24. Content type: Research

    To investigate the effect of perfluorochemical preparations in enhancing radiotherapy, perfluocarbon nanoparticles were by encapsulating perfluorohexane into liposome [lip(PFH)].

    Authors: Linfeng Xu, Xuefeng Qiu, Yanting Zhang, Kai Cao, Xiaozhi Zhao, Jinhui Wu, Yiqiao Hu and Hongqian Guo

    Citation: Journal of Translational Medicine 2016 14:268

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  25. Content type: Research

    Treatment for acute myeloid leukemia (AML) has not significantly changed in the last decades and new therapeutic approaches are needed to achieve prolonged survival rates. Leukemia stem cells (LSC) are respons...

    Authors: María Carmen Lara-Castillo, Josep Maria Cornet-Masana, Amaia Etxabe, Antònia Banús-Mulet, Miguel Ángel Torrente, Meritxell Nomdedeu, Marina Díaz-Beyá, Jordi Esteve and Ruth M. Risueño

    Citation: Journal of Translational Medicine 2016 14:261

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  26. Content type: Research

    TRIM5 and TRIM22 are restriction factors involved in innate immune response and exhibit anti-viral activity. Single nucleotide polymorphisms (SNPs) at TRIM5 and TRIM22 genes have shown to influence several viral ...

    Authors: Luz M. Medrano, Norma Rallón, Juan Berenguer, María A. Jiménez-Sousa, Vicente Soriano, Teresa Aldámiz-Echevarria, Amanda Fernández-Rodríguez, Marcial García, Francisco Tejerina, Isidoro Martínez, José M. Benito and Salvador Resino

    Citation: Journal of Translational Medicine 2016 14:257

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  27. Content type: Research

    Myocardial fibrosis (MF) is a deleterious consequence of aortic valve stenosis (AVS). Global longitudinal strain (GLS) is a novel left ventricular (LV) functional parameter potentially useful to non-invasively...

    Authors: Iacopo Fabiani, Cristian Scatena, Chiara Maria Mazzanti, Lorenzo Conte, Nicola Riccardo Pugliese, Sara Franceschi, Francesca Lessi, Michele Menicagli, Andrea De Martino, Stefano Pratali, Uberto Bortolotti, Antonio Giuseppe Naccarato, Salvatore La Carrubba and Vitantonio Di Bello

    Citation: Journal of Translational Medicine 2016 14:248

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  28. Content type: Research

    The administration of supplemental oxygen to treat ventilatory insufficiency may lead to the formation of reactive oxygen species and subsequent tissue damage. Cytochrome P4501A1 (CYP1A1) can modulate hyperoxi...

    Authors: Jute Richter, Julio Jimenez, Taro Nagatomo, Jaan Toelen, Paul Brady, Thomas Salaets, Flore Lesage, Jeroen Vanoirbeek and Jan Deprest

    Citation: Journal of Translational Medicine 2016 14:247

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  29. Content type: Research

    Mesenchymal stromal cells are a promising option to treat knee osteoarthritis. Their safety and usefulness must be confirmed and the optimal dose established. We tested increasing doses of bone marrow mesenchy...

    Authors: José M. Lamo-Espinosa, Gonzalo Mora, Juan F. Blanco, Froilán Granero-Moltó, Jorge M. Nuñez-Córdoba, Carmen Sánchez-Echenique, José M. Bondía, Jesús Dámaso Aquerreta, Enrique J. Andreu, Enrique Ornilla, Eva M. Villarón, Andrés Valentí-Azcárate, Fermín Sánchez-Guijo, María Consuelo del Cañizo, Juan Ramón Valentí-Nin and Felipe Prósper

    Citation: Journal of Translational Medicine 2016 14:246

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  30. Content type: Research

    Muscle wasting negatively impacts the progress of chronic diseases such as lung cancer (LC) and emphysema, which are in turn interrelated.

    Authors: Anna Salazar-Degracia, David Blanco, Mònica Vilà-Ubach, Gabriel de Biurrun, Carlos Ortiz de Solórzano, Luis M. Montuenga and Esther Barreiro

    Citation: Journal of Translational Medicine 2016 14:244

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  31. Content type: Research

    To study the safety, feasibility and skin effects of irreversible electroporation (IRE) for breast tissue and breast cancer in animal models.

    Authors: Sheng Li, Fei Chen, Lujun Shen, Qi Zeng and Peihong Wu

    Citation: Journal of Translational Medicine 2016 14:238

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  32. Content type: Research

    Ipilimumab (Ipi) improves the survival of advanced melanoma patients with an incremental long-term benefit in 10–15 % of patients. A tumor signature that correlates with this survival benefit could help optimi...

    Authors: Teofila Seremet, Alexander Koch, Yanina Jansen, Max Schreuer, Sofie Wilgenhof, Véronique Del Marmol, Danielle Liènard, Kris Thielemans, Kelly Schats, Mark Kockx, Wim Van Criekinge, Pierre G. Coulie, Tim De Meyer, Nicolas van Baren and Bart Neyns

    Citation: Journal of Translational Medicine 2016 14:232

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  33. Content type: Research

    Though outcome models have been proposed previously, it is unknown whether cutoffs in clinical pregnancy and live birth rates at all ages are able to classify in vitro fertilization (IVF) patients into good-, ...

    Authors: Norbert Gleicher, Vitaly A. Kushnir, Aritro Sen, Sarah K. Darmon, Andrea Weghofer, Yan-Guang Wu, Qi Wang, Lin Zhang, David F. Albertini and David H. Barad

    Citation: Journal of Translational Medicine 2016 14:172

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  34. Content type: Research

    The nasal mucosa plays a key role in conditioning the inhaled air and in regulating the immune response. These functions led many authors to recommend mucosal sparing techniques for the surgical management of...

    Authors: Giampiero Neri, Fiorella Cazzato, Valentina Mastronardi, Mara Pugliese, Maria Antonietta Centurione, Roberta Di Pietro and Lucia Centurione

    Citation: Journal of Translational Medicine 2016 14:164

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  35. Content type: Research

    The genome of multiple myeloma (MM) cells is extremely unstable, characterized by a complex combination of structure and numerical abnormalities. It seems that there are several “myeloma subgroups” which diffe...

    Authors: Fedor Kryukov, Pavel Nemec, Lenka Radova, Elena Kryukova, Samuel Okubote, Jiri Minarik, Zdena Stefanikova, Ludek Pour and Roman Hajek

    Citation: Journal of Translational Medicine 2016 14:150

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  36. Content type: Research

    Many HIV infected individuals with suppressed viral loads experience chronic immune activation frequently developing neurological impairment designated as HIV associated neurocognitive disorder (HAND). Adjunct...

    Authors: Jeffrey S. Barrett, Sergei Spitsin, Ganesh Moorthy, Kyle Barrett, Kate Baker, Andrew Lackner, Florin Tulic, Angela Winters, Dwight L. Evans and Steven D. Douglas

    Citation: Journal of Translational Medicine 2016 14:148

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  37. Content type: Research

    Chronic fatigue syndrome (CFS) is a common and disabling disorder, and a major threat against adolescent health. The pathophysiology is unknown, but alteration of neuroendocrine control systems might be a cent...

    Authors: Vegard Bruun Wyller, Valieria Vitelli, Dag Sulheim, Even Fagermoen, Anette Winger, Kristin Godang and Jens Bollerslev

    Citation: Journal of Translational Medicine 2016 14:121

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    The Erratum to this article has been published in Journal of Translational Medicine 2017 15:157

  38. Content type: Research

    SCLC has limited treatment options and inadequate preclinical models. Promising activity of arsenic trioxide (ASO) recorded in conventional preclinical models of SCLC supported the clinical evaluation of ASO i...

    Authors: Taofeek K. Owonikoko, Guojing Zhang, Hyun S. Kim, Renea M. Stinson, Rabih Bechara, Chao Zhang, Zhengjia Chen, Nabil F. Saba, Suchita Pakkala, Rathi Pillai, Xingming Deng, Shi-Yong Sun, Michael R. Rossi, Gabriel L. Sica, Suresh S. Ramalingam and Fadlo R. Khuri

    Citation: Journal of Translational Medicine 2016 14:111

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  39. Content type: Research

    Acute appendicitis is a common cause for a visit to the emergency department and appendectomy represents the most common emergency procedure in surgery. The rate of negative appendectomy however has remained h...

    Authors: Peter C. Ambe, Daniel Gödde, Lars Bönicke, Marios Papadakis, Stephan Störkel and Hubert Zirngibl

    Citation: Journal of Translational Medicine 2016 14:107

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  40. Content type: Protocol

    Compelling evidence has been accumulated to support the effectiveness of intensive lifestyle intervention in delaying progression to Type 2 diabetes even in people identified as being at high risk determined b...

    Authors: Bernardo Costa, Conxa Castell, Xavier Cos, Claustre Solé, Santiago Mestre, Marta Canela, Antoni Boquet, Joan-Josep Cabré, Francisco Barrio, Gemma Flores-Mateo, Daniel Ferrer-Vidal and Jaana Lindström

    Citation: Journal of Translational Medicine 2016 14:103

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  41. Content type: Research

    BRAF V600 mutant circulating cell-free tumor DNA (BRAF V600mut ctDNA) could serve as a specific biomarker in patients with BRAF V600 mutant melanoma. We analyzed the value of BRAF V600...

    Authors: Max Schreuer, Geert Meersseman, Sari Van Den Herrewegen, Yanina Jansen, Ines Chevolet, Ambre Bott, Sofie Wilgenhof, Teofila Seremet, Bart Jacobs, Ronald Buyl, Geert Maertens and Bart Neyns

    Citation: Journal of Translational Medicine 2016 14:95

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  42. Content type: Research

    Osteoarthritis (OA) is characterized by progressive loss of cartilage in joints, and is a major cause of pain and disability, and imposes significant health care expense. New therapies are being developed to t...

    Authors: Mohammad Haris, Anup Singh, Sanjana Reddy, Puneet Bagga, J. Bruce Kneeland, Fotios P. Tjoumakaris, Hari Hariharan, Francesco M. Marincola and Ravinder Reddy

    Citation: Journal of Translational Medicine 2016 14:92

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  43. Content type: Research

    The mechanism of action of imatinib is known to involve the Fas-mediated apoptosis pathway. Consequently inter-individual variations in this apoptosis pathway might be associated with imatinib response or resi...

    Authors: Qiaoli Zheng, Jiang Cao, Nada Hamad, Hyeoung-Joon Kim, Joon Ho Moon, Sang Kyun Sohn, Chul Won Jung, Jeffrey H. Lipton and Dennis Dong Hwan Kim

    Citation: Journal of Translational Medicine 2016 14:82

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  44. Content type: Research

    Typhoid fever, caused by the human-restricted organism Salmonella Typhi (S. Typhi), is a major public health problem worldwide. Development of novel vaccines remains imperative, but is hampered by an incomplete u...

    Authors: Stephanie Fresnay, Monica A. McArthur, Laurence Magder, Thomas C. Darton, Claire Jones, Claire S. Waddington, Christoph J. Blohmke, Brian Angus, Myron M. Levine, Andrew J. Pollard and Marcelo B. Sztein

    Citation: Journal of Translational Medicine 2016 14:62

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  45. Content type: Review

    Kidney transplantation is the treatment of choice in patients with end stage renal disease. During kidney transplantation ischemia reperfusion injury (IRI) occurs, which is a risk factor for acute kidney injur...

    Authors: T. C. Saat, E. K. van den Akker, J. N. M. IJzermans, F. J. M. F. Dor and R. W. F. de Bruin

    Citation: Journal of Translational Medicine 2016 14:20

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