clinical trials as topic


Summary: Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.

Top Publications

  1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637-48 pubmed
  2. Allison M. Can web 2.0 reboot clinical trials?. Nat Biotechnol. 2009;27:895-902 pubmed publisher
    ..Dozens of companies are trying to leverage social networking and other software tools to accelerate trials and reduce their cost. ..
  3. Cornely O, Ullmann A. Lack of evidence for exposure-response relationship in the use of posaconazole as prophylaxis against invasive fungal infections. Clin Pharmacol Ther. 2011;89:351-2 pubmed publisher
  4. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141-5 pubmed
  5. Abou Zahr A, Bose P, Keating M. Pharmacotherapy of relapsed/refractory chronic lymphocytic leukemia. Expert Opin Pharmacother. 2017;18:857-873 pubmed publisher
    ..Indeed, long term relapse free survival, already achievable with CIT in patients with genetically favorable-risk disease, now appears to be a realistic possibility for most patients with CLL. ..
  6. Hawkes N. Merck ends trial of potential Alzheimer's drug verubecestat. BMJ. 2017;356:j845 pubmed publisher
  7. Schlessinger J, Gilbert E, Cohen J, Kaufman J. New Uses of AbobotulinumtoxinA in Aesthetics. Aesthet Surg J. 2017;37:S45-S58 pubmed publisher
    ..To this end details are also provided of clinical trials currently listed in the main clinical trials database to highlight research areas of particular interest. ..
  8. Sievenpiper J. Sickeningly Sweet: Does Sugar Cause Chronic Disease? No. Can J Diabetes. 2016;40:287-95 pubmed publisher
  9. Olver I. Ethical issues with xenotransplantation clinical trials. Med J Aust. 2016;204:212 pubmed

More Information


  1. Hu Z, Ho A, McArthur H. Combined Radiation Therapy and Immune Checkpoint Blockade Therapy for Breast Cancer. Int J Radiat Oncol Biol Phys. 2017;99:153-164 pubmed publisher
    ..Preclinical and clinical results show that RT in combination with checkpoint blockade may be a promising therapeutic option in breast cancer. ..
  2. Lytvyn Y, Bjornstad P, Udell J, Lovshin J, Cherney D. Sodium Glucose Cotransporter-2 Inhibition in Heart Failure: Potential Mechanisms, Clinical Applications, and Summary of Clinical Trials. Circulation. 2017;136:1643-1658 pubmed publisher
    ..Finally, we provide a detailed overview and summary of ongoing cardiovascular outcome trials with SGLT2 inhibitors. ..
  3. Yu B, Yang G, Li Q, Liu L. Tranexamic acid decreases blood loss in shoulder arthroplasty: A meta-analysis. Medicine (Baltimore). 2017;96:e7762 pubmed publisher
    ..Because of the limited high-quality evidence currently available, additional randomized controlled trials are required. ..
  4. Banerjee C, Chimowitz M. Stroke Caused by Atherosclerosis of the Major Intracranial Arteries. Circ Res. 2017;120:502-513 pubmed publisher
    ..Future research should aim to establish clinical, serological, and imaging biomarkers to identify high-risk patients, and clinical trials evaluating novel therapies should be focused on these patients. ..
  5. Winthrop K, Curtis J, Lindsey S, Tanaka Y, Yamaoka K, Valdez H, et al. Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy. Arthritis Rheumatol. 2017;69:1960-1968 pubmed publisher
    ..Patients receiving treatment with tofacitinib and GCs appear to have a greater risk of developing HZ compared with patients receiving tofacitinib monotherapy without GCs. ..
  6. Lamb Y, Duggan S. Ustekinumab: A Review in Moderate to Severe Crohn's Disease. Drugs. 2017;77:1105-1114 pubmed publisher
    ..Thus, ustekinumab presents a promising alternative treatment option in patients with moderately to severely active Crohn's disease who have failed or are intolerant to treatment with conventional therapies or TNF antagonists. ..
  7. Winick N, Devidas M, Chen S, Maloney K, Larsen E, Mattano L, et al. Impact of Initial CSF Findings on Outcome Among Patients With National Cancer Institute Standard- and High-Risk B-Cell Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group. J Clin Oncol. 2017;35:2527-2534 pubmed publisher
    ..Conclusion Low levels of CNS leukemia, regardless of RBCs, predict inferior outcome and higher rates of CNS relapse. These data suggest that additional augmentation of CNS-directed therapy is warranted for CNS2 disease. ..
  8. Nyaoke B, Mutua G, Sajabi R, Nyasani D, Mureithi M, Anzala O. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya. PLoS ONE. 2017;12:e0183788 pubmed publisher
    ..Education on what is needed (including volunteer participation) to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine clinical trials. ..
  9. Salmeron J, Torres Ibarra L, Bosch F, Cuzick J, Lorincz A, Wheeler C, et al. HPV vaccination impact on a cervical cancer screening program: methods of the FASTER-Tlalpan Study in Mexico. Salud Publica Mex. 2016;58:211-9 pubmed
    ..It will offer valuable information on potential benefits of combining HPV vaccination and hrHPV-based screening to safety extend screening intervals. ..
  10. Blair H, Deeks E. Abatacept: A Review in Rheumatoid Arthritis. Drugs. 2017;77:1221-1233 pubmed publisher
    ..Both IV and SC abatacept were generally well tolerated, with low rates of immunogenicity. Current evidence therefore suggests that abatacept is a useful treatment option for patients with RA. ..
  11. Snowdon C. Qualitative and mixed methods research in trials. Trials. 2015;16:558 pubmed publisher
  12. Huang Q, Chen R, Lin X, Xiang Z. Efficacy of carbonic anhydrase inhibitors in management of cystoid macular edema in retinitis pigmentosa: A meta-analysis. PLoS ONE. 2017;12:e0186180 pubmed publisher
    ..The aim of this meta-analysis is to gain a better understanding of the overall efficacy of CAI treatment...
  13. Elliott J, Grimshaw J, Altman R, Bero L, Goodman S, Henry D, et al. Informatics: Make sense of health data. Nature. 2015;527:31-2 pubmed publisher
  14. Harousseau J, Attal M. How I treat first relapse of myeloma. Blood. 2017;130:963-973 pubmed publisher
    ..The choice of salvage regimen is based on lenalidomide/bortezomib resistance, daratumumab availability, and cost. Autologous transplantation should be considered in younger patients if not used upfront. ..
  15. Hubbard J, Grothey A. Napabucasin: An Update on the First-in-Class Cancer Stemness Inhibitor. Drugs. 2017;77:1091-1103 pubmed publisher
    ..In conclusion, napabucasin may prove useful in targeting cancer stem cells, with the potential to suppress metastasis and prevent relapse in patients with varying cancer types. ..
  16. Smith P. Bionic balance organs: progress in the development of vestibular prostheses. N Z Med J. 2017;130:56-65 pubmed
    ..Vestibular implants are now becoming part of an increasing effort to develop artificial, bionic sensory systems, and this paper provides a review of the progress in this area. ..
  17. Gupta R, Amanam I, Chung V. Current and future therapies for advanced pancreatic cancer. J Surg Oncol. 2017;116:25-34 pubmed publisher
    ..Over the last 10 years, improvements in chemotherapy regimens led to a doubling in median overall survival. Here we review the management of advanced pancreatic cancer and highlight vaccine therapy as a novel modality of treatment. ..
  18. Vetter T, Mascha E. Defining the Primary Outcomes and Justifying Secondary Outcomes of a Study: Usually, the Fewer, the Better. Anesth Analg. 2017;125:678-681 pubmed publisher
    ..Ideally, components of a strong composite endpoint have similar treatment effect, frequency, and severity-with the most important being similar severity. ..
  19. Mayekar M, Bivona T. Current Landscape of Targeted Therapy in Lung Cancer. Clin Pharmacol Ther. 2017;102:757-764 pubmed publisher
  20. Kimmel M, Schanz M, Alscher M. Risk prediction of acute kidney injury by [TIMP-2]•[IGFBP7]. Drugs Today (Barc). 2017;53:349-356 pubmed publisher
    ..Clinical use is currently being tested in different randomized intervention studies. ..
  21. Dikopf M, Vajaranant T, Edward D. Topical treatment of glaucoma: established and emerging pharmacology. Expert Opin Pharmacother. 2017;18:885-898 pubmed publisher
    ..Although few emerging therapies show evidence of retinal ganglion cell and optic nerve neuroprotection in animal models, emerging drugs are focused on lowering IOP, similar to established medicines. ..
  22. Flippot R, Massard C, Auclin E, Azria D, Bourien H, Rochigneux P, et al. [The breakthrough of personalized medicine, new hopes and new challenges]. Bull Cancer. 2017;104:735-743 pubmed publisher
    ..Breaking through those boundaries might lead to a true precision medicine in oncology, which implementation in clinical routine is now expected by patients and physicians. ..
  23. Esbensen A, Hooper S, FIDLER D, Hartley S, Edgin J, d Ardhuy X, et al. Outcome Measures for Clinical Trials in Down Syndrome. Am J Intellect Dev Disabil. 2017;122:247-281 pubmed publisher
    ..This article focuses on measures in the areas of cognition and behavior. ..
  24. Roshanov P, Dennis B, Pasic N, Garg A, Walsh M. When is a meta-analysis conclusive? A guide to Trial Sequential Analysis with an example of remote ischemic preconditioning for renoprotection in patients undergoing cardiac surgery. Nephrol Dial Transplant. 2017;32:ii23-ii30 pubmed publisher
    ..With this and other examples, we demonstrate that the TSA can prevent premature conclusions from meta-analyses. ..
  25. Stein C, Castanotto D. FDA-Approved Oligonucleotide Therapies in 2017. Mol Ther. 2017;25:1069-1075 pubmed publisher
    ..Of all the molecules evaluated as of January 2017, the regulatory authorities assessed that six provided clear clinical benefit in rigorously controlled trials. The story of these six is given in this review. ..
  26. Dejaco C, Brouwer E, Mason J, Buttgereit F, Matteson E, Dasgupta B. Giant cell arteritis and polymyalgia rheumatica: current challenges and opportunities. Nat Rev Rheumatol. 2017;13:578-592 pubmed publisher
    ..This article discusses the implications of recent developments in our understanding of GCA and PMR, as well as the unmet needs concerning epidemiology, pathogenesis, imaging and treatment of these diseases. ..
  27. Fernandes G, Sternberg C, Lopes G, Chammas R, Gifoni M, Gil R, et al. The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC). Braz J Med Biol Res. 2018;51:e7214 pubmed publisher
    ..We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society. ..
  28. Huang W, Hung H, Hamasaki T, Hsiao C. Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints. PLoS ONE. 2017;12:e0180405 pubmed publisher
    ..The sample size required for the region of interest can also be evaluated based on these three criteria. ..
  29. Fong M, Caterson I, Madigan C. Are large dinners associated with excess weight, and does eating a smaller dinner achieve greater weight loss? A systematic review and meta-analysis. Br J Nutr. 2017;118:616-628 pubmed publisher
    ..Recommendations to reduce evening intake for weight loss cannot be substantiated by clinical evidence, and more well-controlled intervention trials are needed...
  30. Chiappella A, Santambrogio E, Castellino A, Nicolosi M, Vitolo U. Integrating novel drugs to chemoimmunotherapy in diffuse large B-cell lymphoma. Expert Rev Hematol. 2017;10:697-705 pubmed publisher
    ..Despite encouraging results using novel drugs in the setting of relapsed/refractory DLBCL, the rate of failures still remains at 40%; for these reason, continued participation in clinical trials should be encouraged. ..
  31. Woolfall K, Frith L, Dawson A, Gamble C, Lyttle M, Young B. Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials. Arch Dis Child Educ Pract Ed. 2016;101:49-53 pubmed publisher
  32. Andrade C. Ketamine for Depression, 2: Diagnostic and Contextual Indications. J Clin Psychiatry. 2017;78:e555-e558 pubmed publisher
    ..It is not clear whether the presence of psychotic symptoms is a contraindication for ketamine use. Issues related to these indications and contexts are briefly discussed. ..
  33. Tawil R, Padberg G, Shaw D, van der Maarel S, Tapscott S. Clinical trial preparedness in facioscapulohumeral muscular dystrophy: Clinical, tissue, and imaging outcome measures 29-30 May 2015, Rochester, New York. Neuromuscul Disord. 2016;26:181-6 pubmed publisher
  34. Saglio G, Le Coutre P, Cortes J, Mayer J, Rowlings P, Mahon F, et al. Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios. Ann Hematol. 2017;96:1303-1313 pubmed publisher
    ..Comparison of observed and expected event rates through standardized incidence ratios indicates that dasatinib does not increase risk for cardiovascular ischemic events compared with external reference populations. ..
  35. Sterne J, Hernán M, Reeves B, Savovic J, Berkman N, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919 pubmed publisher
  36. Jiang B, Ball R, Michel P, Jovin T, Desai M, Eskandari A, et al. Prevalence of Imaging Biomarkers to Guide the Planning of Acute Stroke Reperfusion Trials. Stroke. 2017;48:1675-1677 pubmed publisher
    ..As part of the feasibility analysis in stroke clinical trials, this analysis and the resulting tables can help investigators determine sample size and the number needed to screen. ..
  37. Todorova D, Simoncini S, Lacroix R, Sabatier F, Dignat George F. Extracellular Vesicles in Angiogenesis. Circ Res. 2017;120:1658-1673 pubmed publisher
  38. Chew E. Nutrition, Genes, and Age-Related Macular Degeneration: What Have We Learned from the Trials?. Ophthalmologica. 2017;238:1-5 pubmed publisher
    ..The use of genetic testing prior to AMD therapies such as administering AREDS supplements is not recommended by the American Academy of Ophthalmology and other organizations. ..
  39. Morrison C. Landmark green light for Mosquirix malaria vaccine. Nat Biotechnol. 2015;33:1015-6 pubmed publisher
  40. Bijker E, Sauerwein R, Bijker W. Controlled human malaria infection trials: How tandems of trust and control construct scientific knowledge. Soc Stud Sci. 2016;46:56-86 pubmed
    ..Understanding tandems of trust and control results in setting some agendas for both clinical trial research and science and technology studies. ..
  41. Ruiz C, Hahn R, Berrebi A, Borer J, Cutlip D, Fontana G, et al. Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement. J Am Coll Cardiol. 2017;69:2067-2087 pubmed publisher
    ..The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted. ..
  42. Flamant M, Paul S, Roblin X. Golimumab for the treatment of ulcerative colitis. Expert Opin Biol Ther. 2017;17:879-886 pubmed publisher
    ..In the case of loss of response to a first anti-TNF agent, therapeutic drug monitoring is essential to determine the most suitable therapeutic option. ..
  43. Ahmad M, Ahmed O, Schnepp B, Johnson P. Engineered Expression of Broadly Neutralizing Antibodies Against Human Immunodeficiency Virus. Annu Rev Virol. 2017;4:491-510 pubmed publisher
  44. Winsett F, Lewis D, Duvic M. Mogamulizumab for the treatment of relapsed or refractory adult T-cell leukemia-lymphoma. Expert Rev Hematol. 2017;10:757-760 pubmed publisher
    ..Determining the optimal combination of mogamulizumab with conventional and novel therapies remains an important strategy to improve the prognosis of patients with ATL. ..
  45. Kunnumakkara A, Bordoloi D, Harsha C, Banik K, Gupta S, Aggarwal B. Curcumin mediates anticancer effects by modulating multiple cell signaling pathways. Clin Sci (Lond). 2017;131:1781-1799 pubmed publisher
    ..The focus of this review is to discuss the molecular basis for the anticancer activities of curcumin based on preclinical and clinical findings. ..
  46. French J, Koepp M, Naegelin Y, Vigevano F, Auvin S, Rho J, et al. Clinical studies and anti-inflammatory mechanisms of treatments. Epilepsia. 2017;58 Suppl 3:69-82 pubmed publisher
    ..A summary of some of those approaches appears below, as well as a discussion of the issues facing clinical trials in this new domain. ..
  47. Ikeda H. [Cancer Immunotherapy Utilizing T Cell Receptor Gene Engineering]. Gan To Kagaku Ryoho. 2017;44:273-277 pubmed
  48. Bassi S, Tripathi T, Monziani A, Di Leva F, Biagioli M. Epigenetics of Huntington's Disease. Adv Exp Med Biol. 2017;978:277-299 pubmed publisher
    ..Thus, the overarching goal of this chapter is to discuss the current status of the literature, reviewing how an aberrant epigenetic landscape can contribute to altered gene expression and neuronal dysfunction in HD. ..
  49. Ray Coquard I, Pujade Lauraine E, Le Cesne A, Pautier P, Vacher Lavenue M, Trama A, et al. Improving treatment results with reference centres for rare cancers: where do we stand?. Eur J Cancer. 2017;77:90-98 pubmed publisher
    ..This article will summarise these experiences and the potential benefit for patients. ..
  50. Christopher P, Appelbaum P, Truong D, Albert K, Maranda L, Lidz C. Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials. PLoS ONE. 2017;12:e0184224 pubmed publisher
    ..Additional study of this intervention is required in real-world clinical trials. ..
  51. Spadaccio C, Nappi F, Sablayrolles J, Sutherland F. TAVR vs SAVR: Rising Expectations and Changing Indications for Surgery in Response to PARTNER II. Semin Thorac Cardiovasc Surg. 2017;29:8-11 pubmed publisher
    ..Considerations on the parallel progress of SAVR and on the need for a behavioral change in the surgical community are discussed. ..
  52. Ferlazzo E, Sueri C, Gasparini S, Russo E, Cianci V, Ascoli M, et al. Methodological issues associated with clinical trials in epilepsy. Expert Rev Clin Pharmacol. 2017;10:1103-1108 pubmed publisher
    ..Expert commentary: clinical trial methodology needs to be optimized to better address regulatory agencies requirements and to encounter both patients' and clinicians' needs. ..
  53. Kondo E, Maeda Y. Immune checkpoint inhibitors and allogeneic hematopoietic stem cell transplantation. Rinsho Ketsueki. 2017;58:506-513 pubmed publisher
    ..Further studies on immune checkpoint inhibitors in the treatment of hematological malignancies are warranted. ..