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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. 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

    Content type: Research

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  2. 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

    Content type: Research

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  3. 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

    Content type: Research

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  4. 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

    Content type: Review

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  5. Labour is perhaps the most hazardous time in pregnancy. As many as 20 % of cerebral palsy cases in term infants result from intrapartum events and up to 63 % of babies who develop intrapartum compromise have n...

    Authors: Liam Dunn, Vicki Flenady and Sailesh Kumar

    Citation: Journal of Translational Medicine 2016 14:15

    Content type: Protocol

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  6. Clinical diagnostic research relies upon the collection of tissue samples, and for those samples to be representative of the in vivo situation. Tissue collection procedures, including post-operative ischemia, ...

    Authors: Florian T. Unger, Nicole Lange, Jana Krüger, Carolyn Compton, Helen Moore, Lokesh Agrawal, Hartmut Juhl and Kerstin A. David

    Citation: Journal of Translational Medicine 2016 14:6

    Content type: Research

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  7. Alliance Against Cancer (ACC) was established in Rome in 2002 as a consortium of six Italian comprehensive cancer centers (Founders). The aims of ACC were to promote a network among Italian oncologic instituti...

    Authors: Paolo De Paoli, Gennaro Ciliberto, Manlio Ferrarini, PierGiuseppe Pelicci, Paolo Dellabona, Francesco De Lorenzo, Alberto Mantovani, Pellegrino Musto, Giuseppe Opocher, Piero Picci, Walter Ricciardi and Ruggero De Maria

    Citation: Journal of Translational Medicine 2015 13:360

    Content type: Commentary

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  8. Renal fibrosis is a main cause of end-stage renal disease. Clinically, there is no beneficial treatment that can effectively reverse the progressive loss of renal function. We recently synthesized a novel prot...

    Authors: Cheng Yang, Ye Cao, Yi Zhang, Long Li, Ming Xu, Yaqiu Long, Ruiming Rong and Tongyu Zhu

    Citation: Journal of Translational Medicine 2015 13:355

    Content type: Research

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  9. Atrial fibrillation is a progressive arrhythmia, the exact mechanism underlying the progressive nature of recurrent AF episodes is still unknown. Recently, it was found that key players of the protein quality ...

    Authors: Eva A. H. Lanters, Denise M. S. van Marion, Charles Kik, Herman Steen, Ad J. J. C. Bogers, Maurits A. Allessie, Bianca J. J. M. Brundel and Natasja M. S. de Groot

    Citation: Journal of Translational Medicine 2015 13:347

    Content type: Protocol

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  10. Opinion-based commentary about the complex reality of being a clinician-scientist in today’s modern biomedical environment. The essay uses the beautiful, but old, poem “If” from Rudyard Kipling to draw a paral...

    Authors: Pierre R. Smeesters

    Citation: Journal of Translational Medicine 2015 13:345

    Content type: Editorial

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  11. Many kidneys are rejected for transplantation due to inadequate in situ perfusion during organ retrieval because of the risk of additional ischaemic injury and microvasculature thrombosis. This study describes...

    Authors: Sarah A. Hosgood, A. D. Barlow, J. Dormer and M. L. Nicholson

    Citation: Journal of Translational Medicine 2015 13:329

    Content type: Research

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  12. There is growing evidence that variations in the gene encoding inosine triphosphate pyrophosphohydrolase (ITPase), known as inosine triphosphatase (ITPA), are related to hemolytic anemia, which is frequently obse...

    Authors: Daniel Pineda-Tenor, Mónica García-Álvarez, María A. Jiménez-Sousa, Sonia Vázquez-Morón and Salvador Resino

    Citation: Journal of Translational Medicine 2015 13:320

    Content type: Research

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  13. The strategy of using fecal microbiota transplantation (FMT) for refractory ulcerative colitis (UC) remains unclear if single FMT failed to induce remission. This study aimed to evaluate the efficacy and safet...

    Authors: Bota Cui, Pan Li, Lijuan Xu, Youquan Zhao, Huiquan Wang, Zhaoyuan Peng, Hai’e Xu, Jie Xiang, Zhi He, Ting Zhang, Yongzhan Nie, Kaichun Wu, Daiming Fan, Guozhong Ji and Faming Zhang

    Citation: Journal of Translational Medicine 2015 13:298

    Content type: Research

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  14. NK cells can destroy tumor cells without prior sensitization or immunization. Tumors often lose expression of MHC molecules and/or antigens. However, NK cells can lyse tumor cells in a non-MHC-restricted manne...

    Authors: Naoyuki Sakamoto, Takeshi Ishikawa, Satoshi Kokura, Tetsuya Okayama, Kaname Oka, Mitsuko Ideno, Fumiyo Sakai, Akiko Kato, Masashige Tanabe, Tatsuji Enoki, Junichi Mineno, Yuji Naito, Yoshito Itoh and Toshikazu Yoshikawa

    Citation: Journal of Translational Medicine 2015 13:277

    Content type: Research

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  15. The latest high-throughput sequencing technologies show that there are more than 1000 types of microbiota in the human gut. These microbes are not only important to maintain human health, but also closely rela...

    Authors: Weilin Wang, Shaoyan Xu, Zhigang Ren, Jianwen Jiang and Shusen Zheng

    Citation: Journal of Translational Medicine 2015 13:275

    Content type: Review

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  16. In human medicine clinical trials are legally required for drug development and approval. In contrast, clinical trials in small animal cancer patients are less common and legally perceived as animal experiment...

    Authors: Irene Fürdös, Judit Fazekas, Josef Singer and Erika Jensen-Jarolim

    Citation: Journal of Translational Medicine 2015 13:265

    Content type: Review

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  17. The American College of Obstetrics and Gynecology (ACOG) and Maternal Fetal Medicine (MFM) Societies recommended that abnormal cfDNA fetal results should be confirmed by amniocentesis and karyotyping. Our results...

    Authors: Roger V Lebo, Robert W Novak, Katherine Wolfe, Melonie Michelson, Haynes Robinson and Melissa S Mancuso

    Citation: Journal of Translational Medicine 2015 13:260

    Content type: Research

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  18. In clinic settings, rel apsed leukemic patients are found to be more fragile to chemotherapy due to delayed or incomplete hematopoietic recovery, and hematopoiesis of these patients seem to be impaired.

    Authors: Chuanhe Jiang, Xiaoxia Hu, Libing Wang, Hui Cheng, Yan Lin, Yakun Pang, Weiping Yuan, Tao Cheng and Jianmin Wang

    Citation: Journal of Translational Medicine 2015 13:234

    Content type: Research

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  19. The failure in standard triple therapy has recently increased to high levels in China, primarily because of insufficient patient compliance, antimicrobial resistance, and high costs. Effective prevention and e...

    Authors: Dailun Hu, Feng Zhang, Jikun Zhou, Baohong Xu, Hongying Zhang, Huiqin Qiang, Shuguang Ren, Baoen Shan, Changfu Yin, Zhitao Zhang, Xian Wang, Chuan Zhao and Zhongli Shi

    Citation: Journal of Translational Medicine 2015 13:205

    Content type: Research

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  20. Corticosteroids are preferred to treat patients with active IgA nephropathy (IgAN), and beneficial effects from the short-term use of corticosteroids have been confirmed. However, a large number of patients wi...

    Authors: Yanhong Yuan, Qin Wang, Zhaohui Ni, Xiajing Che, Liou Cao, Xinghua Shao, Minfang Zhang, Yuanyuan Xie, Chaojun Qi, Wenyan Zhou, Lei Tian and Shan Mou

    Citation: Journal of Translational Medicine 2015 13:186

    Content type: Research

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  21. Influenza H5N1 is one subtype of the influenza A virus which can infect human bodies and lead to death. Timely diagnosis before its breakout is vital to the human health. The current clinical biochemical diagn...

    Authors: Min Zhu, Xue Gong, Yonghong Hu, Weijun Ou and Yakun Wan

    Citation: Journal of Translational Medicine 2014 12:352

    Content type: Research

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  22. Although the efficacy of zoledronic acid in postmenopausal women with breast cancer has been suggested, the underlying mechanism has not been fully clarified. Therefore, which patients may benefit from zoledro...

    Authors: Eriko Sumi, Tomoharu Sugie, Kenichi Yoshimura, Harue Tada, Takafumi Ikeda, Eiji Suzuki, Yoshimasa Tanaka, Satoshi Teramukai, Akira Shimizu, Masakazu Toi and Nagahiro Minato

    Citation: Journal of Translational Medicine 2014 12:310

    Content type: Protocol

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  23. Hereditary hearing loss is genetically heterogeneous, and hundreds of mutations in than 60 genes are involved in this disease. Therefore, it is difficult to identify the causative gene mutations involved. In t...

    Authors: Qinjun Wei, Hongmei Zhu, Xuli Qian, Zhibin Chen, Jun Yao, Yajie Lu, Xin Cao and Guangqian Xing

    Citation: Journal of Translational Medicine 2014 12:311

    Content type: Research

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  24. Tumor cells killed by radiation therapy (RT) are a potentially good source of antigens for dendritic cell (DC) uptake and presentation to T-cells. RT upregulates cell death receptors such as Fas/CD95 and MHC-I...

    Authors: Laura Ridolfi, Francesco de Rosa, Ruggero Ridolfi, Giorgia Gentili, Linda Valmorri, Emanuela Scarpi, Elisabetta Parisi, Antonino Romeo and Massimo Guidoboni

    Citation: Journal of Translational Medicine 2014 12:262

    Content type: Protocol

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  25. Umbilical cord mesenchymal stem cells (UCMSCs) have a considerable advantage and potential in treating for central nervous system diseases and have become a novel alternative treatment for spinal cord injury. ...

    Authors: Hongbin Cheng, Xuebin Liu, Rongrong Hua, Guanghui Dai, Xiaodong Wang, Jianhua Gao and Yihua An

    Citation: Journal of Translational Medicine 2014 12:253

    Content type: Research

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  26. Accurate estimation of a burned area is crucial to decisions about fluid resuscitation, surgical options, nutritional support, and prognosis. Widely used clinical methods to estimate a burn area are two-dimens...

    Authors: Wen-bo Sheng, Ding Zeng, Yan Wan, Li Yao, Hong-tai Tang and Zhao-fan Xia

    Citation: Journal of Translational Medicine 2014 12:242

    Content type: Research

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  27. Human placenta releases specific nanovesicles (i.e. exosomes) into the maternal circulation during pregnancy, however, the presence of placenta-derived exosomes in maternal blood during early pregnancy remains to...

    Authors: Suchismita Sarker, Katherin Scholz-Romero, Alejandra Perez, Sebastian E Illanes, Murray D Mitchell, Gregory E Rice and Carlos Salomon

    Citation: Journal of Translational Medicine 2014 12:204

    Content type: Research

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  28. Vaccination with dendritic cells (DC) loaded with tumor antigens elicits tumor-specific immune responses capable of killing cancer cells without inducing meaningful side-effects. Patients with advanced melanom...

    Authors: Francesco de Rosa, Laura Ridolfi, Ruggero Ridolfi, Giorgia Gentili, Linda Valmorri, Oriana Nanni, Massimiliano Petrini, Laura Fiammenghi, Anna Maria Granato, Valentina Ancarani, Elena Pancisi, Valentina Soldati, Serena Cassan, Angela Riccobon, Elisabetta Parisi, Antonino Romeo…

    Citation: Journal of Translational Medicine 2014 12:209

    Content type: Protocol

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  29. Rapidly determining the complex genetic basis of Hypertrophic cardiomyopathy (HCM) is vital to better understanding and optimally managing this common polygenetic cardiovascular disease.

    Authors: Zongzhe Li, Jin Huang, Jinzhao Zhao, Chen Chen, Hong Wang, Hu Ding, Dao Wu Wang and Dao Wen Wang

    Citation: Journal of Translational Medicine 2014 12:173

    Content type: Methodology

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  30. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a multi-system illness characterized, in part, by increased fatigue following minimal exertion, cognitive impairment, poor recovery to physical an...

    Authors: Betsy A Keller, John Luke Pryor and Ludovic Giloteaux

    Citation: Journal of Translational Medicine 2014 12:104

    Content type: Research

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  31. CD40-CD40 ligand (CD40L) interaction is considered to contribute to the promotion of prothrombotic responses and production of angiogenesis-associated factor in addition to adaptive immune responses. Recently,...

    Authors: Hye Won Chung and Jong-Baeck Lim

    Citation: Journal of Translational Medicine 2014 12:102

    Content type: Research

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  32. Immunotherapy offers a promising novel approach for the treatment of cancer and both adoptive T-cell transfer and immune modulation lead to regression of advanced melanoma. However, the potential synergy betwe...

    Authors: Emanuela Romano, Olivier Michielin, Verena Voelter, Julien Laurent, Hélène Bichat, Athina Stravodimou, Pedro Romero, Daniel E Speiser, Frédéric Triebel, Serge Leyvraz and Alexandre Harari

    Citation: Journal of Translational Medicine 2014 12:97

    Content type: Research

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  33. Chemoradiation therapy (CRT) has been widely used for unresectable esophageal squamous cell carcinoma (ESCC) patients. However, many patients develop local recurrence after CRT. In this study, we hypothesized ...

    Authors: Hisae Iinuma, Ryoji Fukushima, Tsuyoshi Inaba, Junko Tamura, Taisuke Inoue, Etsushi Ogawa, Masahiro Horikawa, Yoshibumi Ikeda, Noriyuki Matsutani, Kazuyoshi Takeda, Koji Yoshida, Takuya Tsunoda, Tadashi Ikeda, Yusuke Nakamura and Kota Okinaga

    Citation: Journal of Translational Medicine 2014 12:84

    Content type: Research

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  34. Red cell distribution width (RDW) has been recognized as a novel marker for several cardiovascular diseases. The aim of this study was to evaluate the association between RDW levels and the presence of isolate...

    Authors: Xiao-Lin Li, Li-Feng Hong, Yan-Jun Jia, Shao-Ping Nie, Yuan-Lin Guo, Rui-Xia Xu, Cheng-Gang Zhu, Li-Xin Jiang and Jian-Jun Li

    Citation: Journal of Translational Medicine 2014 12:62

    Content type: Research

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  35. Although patients with liver failure exhibit a generalized inflammatory-imbalance status, substantial evidence indicates that this immunosuppressive or anti-inflammatory state may be deleterious. Increased exp...

    Authors: Min Zhang, Yinong Ye, Fenglan Wang, Jianyun Zhu, Qiyi Zhao, Yubao Zheng, Yurong Gu, Chan Xie, Zhanlian Huang, Qiang Tai, Yutian Chong and Zhiliang Gao

    Citation: Journal of Translational Medicine 2014 12:60

    Content type: Research

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  36. The primary aim of this pilot study was to determine the feasibility and safety of an adoptive transfer and in vivo expansion of human haploidentical γδ T lymphocytes.

    Authors: Martin Wilhelm, Manfred Smetak, Kerstin Schaefer-Eckart, Brigitte Kimmel, Josef Birkmann, Hermann Einsele and Volker Kunzmann

    Citation: Journal of Translational Medicine 2014 12:45

    Content type: Research

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  37. Parenterally administered ascorbic acid modulates sepsis-induced inflammation and coagulation in experimental animal models. The objective of this randomized, double-blind, placebo-controlled, phase I trial wa...

    Authors: Alpha A Fowler III, Aamer A Syed, Shelley Knowlson, Robin Sculthorpe, Don Farthing, Christine DeWilde, Christine A Farthing, Terri L Larus, Erika Martin, Donald F Brophy, Seema Gupta, Bernard J Fisher and Ramesh Natarajan

    Citation: Journal of Translational Medicine 2014 12:32

    Content type: Research

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  38. PAD is a disabling, chronic condition of the lower extremities that affects approximately 8 million people in the United States. The purpose of this study was to determine whether an innovative home-based walk...

    Authors: W Jack Rejeski, Bonnie Spring, Kathryn Domanchuk, Huimin Tao, Lu Tian, Lihui Zhao and Mary M McDermott

    Citation: Journal of Translational Medicine 2014 12:29

    Content type: Research

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  39. Progressive Supranuclear Palsy (PSP) is a sporadic and progressive neurodegenerative disease which belongs to the family of tauopathies and involves both cortical and subcortical structures. No effective thera...

    Authors: Rosaria Giordano, Margherita Canesi, Maurizio Isalberti, Ioannis Ugo Isaias, Tiziana Montemurro, Mariele Viganò, Elisa Montelatici, Valentina Boldrin, Riccardo Benti, Agostino Cortelezzi, Nicola Fracchiolla, Lorenza Lazzari and Gianni Pezzoli

    Citation: Journal of Translational Medicine 2014 12:14

    Content type: Protocol

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  40. This study compared the clinical efficacies, advantages and disadvantages of two transplantation approaches for treating spinal cord injury: open surgical exploration combined with local stem cell transplantat...

    Authors: Guanghui Dai, Xuebin Liu, Zan Zhang, Xiaodong Wang, Min Li, Hongbin Cheng, Rongrong Hua, Jing Shi, Renzhi Wang, Chuan Qin, Jianhua Gao and Yihua An

    Citation: Journal of Translational Medicine 2013 11:315

    Content type: Research

    Published on:

  41. The goal of this study was to test the hypothesis that autoantibodies against M2-muscarinic acetylcholine receptor (M2-AAB) are associated with severe preeclampsia and increased risk of adverse perinatal outcomes...

    Authors: Yanfang Li, Guiling Ma, Zhiyong Zhang, Yin Yue, Yuting Yuan, Yidan Wang, Guobin Miao and Lin Zhang

    Citation: Journal of Translational Medicine 2013 11:285

    Content type: Research

    Published on:

  42. Acute myeloid leukemia (AML) and other aggressive refractory hematological malignancies unresponsive to upfront therapy remain difficult conditions to treat. Often, the focus of therapy is centered on achievin...

    Authors: John L Reagan, Loren D Fast, Howard Safran, Martha Nevola, Eric S Winer, Jorge J Castillo, James N Butera, Matthew I Quesenberry, Carolyn T Young and Peter J Quesenberry

    Citation: Journal of Translational Medicine 2013 11:150

    Content type: Protocol

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  43. Ovarian cancer, like most solid tumors, is in dire need of effective therapies. The significance of this trial lies in its promise to spearhead the development of combination immunotherapy and to introduce nov...

    Authors: Lana E Kandalaft, Cheryl L Chiang, Janos Tanyi, Greg Motz, Klara Balint, Rosemarie Mick and George Coukos

    Citation: Journal of Translational Medicine 2013 11:149

    Content type: Commentary

    Published on:

  44. Inducing donor-specific tolerance in renal transplant patients could potentially prevent allograft rejection and calcineurin inhibitor nephrotoxicity. Combined kidney and hematopoietic stem cell transplant fro...

    Authors: Duojiao Wu, Guisheng Qi, Xuanchuan Wang, Ming Xu, Ruiming Rong, Xiangdong Wang and Tongyu Zhu

    Citation: Journal of Translational Medicine 2012 10:182

    Content type: Research

    Published on:

  45. Chronic inflammation may contribute to insulin resistance (IR), metabolic syndrome and atherosclerosis although evidence of causality is lacking in humans. We hypothesized that very low-dose experimental endot...

    Authors: Nehal N Mehta, Sean P Heffron, Parth N Patel, Jane Ferguson, Rachana D Shah, Christine C Hinkle, Parasuram Krishnamoorthy, Rhia Shah, Jennifer Tabita-Martinez, Karen Terembula, Stephen R Master, Michael R Rickels and Muredach P Reilly

    Citation: Journal of Translational Medicine 2012 10:124

    Content type: Research

    Published on:

  46. The potent ribonucleotide reductase (RNR) inhibitor 3-aminopyridine-2-carboxyaldehyde-thiosemicarbazone (3-AP) was tested as a chemosensitizer for restored cisplatin-mediated cytotoxicity in platinum-resistant...

    Authors: Charles Kunos, Tomas Radivoyevitch, Fadi W Abdul-Karim, James Fanning, Ovadia Abulafia, Albert J Bonebrake and Lydia Usha

    Citation: Journal of Translational Medicine 2012 10:79

    Content type: Research

    Published on:

  47. Nearly one-third of the United States adult population suffers from hypertension. Hydrochlorothiazide (HCTZ), one of the most commonly used medications to treat hypertension, has variable efficacy. The renal e...

    Authors: Julio D Duarte, Issam Zineh, Ben Burkley, Yan Gong, Taimour Y Langaee, Stephen T Turner, Arlene B Chapman, Eric Boerwinkle, John G Gums, Rhonda M Cooper-DeHoff, Amber L Beitelshees, Kent R Bailey, Roger B Fillingim, Bruce C Kone and Julie A Johnson

    Citation: Journal of Translational Medicine 2012 10:56

    Content type: Research

    Published on:

  48. To determine whether office, home, ambulatory daytime and nighttime blood pressure (BP) responses to antihypertensive drug therapy measure the same signal and which method provides greatest power to identify g...

    Authors: Stephen T Turner, Gary L Schwartz, Arlene B Chapman, Amber L Beitelshees, John G Gums, Rhonda M Cooper-DeHoff, Eric Boerwinkle, Julie A Johnson and Kent R Bailey

    Citation: Journal of Translational Medicine 2012 10:47

    Content type: Research

    Published on:

  49. Concomitant with the development of in vitro diagnostic multivariate index assays (IVDMIAs) to improve the diagnostic efficiency of ovarian cancer detection is the need to identify appropriate biostatistical appr...

    Authors: Dominic J Autelitano, Linda Raineri, Kate Knight, Kelly Bannister and Gregory E Rice

    Citation: Journal of Translational Medicine 2012 10:45

    Content type: Research

    Published on:

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