clinical trials

Summary

Summary: 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. ncbi Estimating the relative risk in cohort studies and clinical trials of common outcomes
    Louise Anne McNutt
    Department of Epidemiology, School of Public Health, University at Albany, State University of New York, Rensselaer, NY 12144, USA
    Am J Epidemiol 157:940-3. 2003
  2. ncbi Random-effects model for meta-analysis of clinical trials: an update
    Rebecca DerSimonian
    Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA
    Contemp Clin Trials 28:105-14. 2007
  3. ncbi Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines
    Scott M Grundy
    Circulation 110:227-39. 2004
  4. ncbi National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report
    Alexandra H Filipovich
    Cincinnati Children s Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio 45229, USA
    Biol Blood Marrow Transplant 11:945-56. 2005
  5. ncbi Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines
    Scott M Grundy
    J Am Coll Cardiol 44:720-32. 2004
  6. pmc Comparison of treatment effects between animal experiments and clinical trials: systematic review
    Pablo Perel
    Crash Trials Coordinating Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT
    BMJ 334:197. 2007
  7. ncbi Natural products to drugs: natural product derived compounds in clinical trials
    Mark S Butler
    MerLion Pharmaceuticals, 1 Science Park Road, The Capricorn 05 01, Singapore Science Park II, Singapore 117528
    Nat Prod Rep 22:162-95. 2005
  8. ncbi Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
    Dennis C Turk
    Department of Anesthesiology, University of Washington, Seattle, WA 98195, USA
    Pain 106:337-45. 2003
  9. ncbi Evaluating medication effects outside of clinical trials: new-user designs
    Wayne A Ray
    Division of Pharmacoepidemiology, Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232, USA
    Am J Epidemiol 158:915-20. 2003
  10. ncbi Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials
    Michael Grundman
    Alzheimer s Disease Cooperative Study, Department of Neurosciences, University of California San Diego, 8950 Villa La Jolla Drive, Suite 227, La Jolla, CA 92037, USA
    Arch Neurol 61:59-66. 2004

Detail Information

Publications335 found, 100 shown here

  1. ncbi Estimating the relative risk in cohort studies and clinical trials of common outcomes
    Louise Anne McNutt
    Department of Epidemiology, School of Public Health, University at Albany, State University of New York, Rensselaer, NY 12144, USA
    Am J Epidemiol 157:940-3. 2003
    ..Hypothetical data are used to illustrate statistical methods with readily accessible computer software...
  2. ncbi Random-effects model for meta-analysis of clinical trials: an update
    Rebecca DerSimonian
    Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA
    Contemp Clin Trials 28:105-14. 2007
    ..The two-step methods approximate the optimal iterative method better than the earlier one-step non-iterative methods...
  3. ncbi Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines
    Scott M Grundy
    Circulation 110:227-39. 2004
    ..Since the publication of ATP III, 5 major clinical trials of statin therapy with clinical end points have been published...
  4. ncbi National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report
    Alexandra H Filipovich
    Cincinnati Children s Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio 45229, USA
    Biol Blood Marrow Transplant 11:945-56. 2005
    ..It is currently recommended that systemic therapy be considered for patients who meet criteria for chronic GVHD of moderate to severe global severity...
  5. ncbi Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines
    Scott M Grundy
    J Am Coll Cardiol 44:720-32. 2004
    ..Since the publication of ATP III, 5 major clinical trials of statin therapy with clinical end points have been published...
  6. pmc Comparison of treatment effects between animal experiments and clinical trials: systematic review
    Pablo Perel
    Crash Trials Coordinating Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT
    BMJ 334:197. 2007
    To examine concordance between treatment effects in animal experiments and clinical trials. Study design Systematic review.
  7. ncbi Natural products to drugs: natural product derived compounds in clinical trials
    Mark S Butler
    MerLion Pharmaceuticals, 1 Science Park Road, The Capricorn 05 01, Singapore Science Park II, Singapore 117528
    Nat Prod Rep 22:162-95. 2005
    Natural product and natural product-derived compounds that are being evaluated in clinical trials or in registration (current 31 December 2004) have been reviewed...
  8. ncbi Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
    Dennis C Turk
    Department of Anesthesiology, University of Washington, Seattle, WA 98195, USA
    Pain 106:337-45. 2003
    To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain...
  9. ncbi Evaluating medication effects outside of clinical trials: new-user designs
    Wayne A Ray
    Division of Pharmacoepidemiology, Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232, USA
    Am J Epidemiol 158:915-20. 2003
    Recent clinical trials demonstrating that hormone replacement therapy (HRT) does not prevent coronary heart disease in women have again raised doubts concerning observational studies...
  10. ncbi Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials
    Michael Grundman
    Alzheimer s Disease Cooperative Study, Department of Neurosciences, University of California San Diego, 8950 Villa La Jolla Drive, Suite 227, La Jolla, CA 92037, USA
    Arch Neurol 61:59-66. 2004
    ..The Memory Impairment Study (MIS) is a multicenter clinical trial in patients with MCI designed to evaluate whether vitamin E or donepezil is effective at delaying the time to a clinical diagnosis of AD...
  11. ncbi Role and relevance of neurocognitive assessment in clinical trials of patients with CNS tumors
    Christina A Meyers
    Department of Neuro Oncology, The University of Texas M D Anderson Cancer Center, Houston, TX 77030, USA
    J Clin Oncol 24:1305-9. 2006
    The inclusion of neurocognitive end points in clinical trials of patients with CNS tumors is increasing...
  12. ncbi Hepatitis C Virus prevalence among patients infected with Human Immunodeficiency Virus: a cross-sectional analysis of the US adult AIDS Clinical Trials Group
    Kenneth E Sherman
    Hepatology and Liver Transplant Medicine, Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, 45267, USA
    Clin Infect Dis 34:831-7. 2002
    ..a 213-sample subcohort was selected by use of risk-based sampling from 2 large prospective US Adult AIDS Clinical Trials Group clinical trials. HCV prevalence, HCV RNA level, and genotype were determined...
  13. ncbi OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited
    T Pham
    Rene Descartes University, Cochin Hospital, 27 rue du Faubourg Saint Jacques, 75014 Paris, France
    Osteoarthritis Cartilage 12:389-99. 2004
    The OARSI Standing Committee for Clinical Trials Response Criteria Initiative had developed two sets of responder criteria to present the results of changes after treatment in three symptomatic domains (pain, function, and patient's ..
  14. ncbi The continuing unethical conduct of underpowered clinical trials
    Scott D Halpern
    Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 108 Blockley Hall, 423 Guardian Dr, Philadelphia, PA 19104 6021, USA
    JAMA 288:358-62. 2002
    Despite long-standing critiques of the conduct of underpowered clinical trials, the practice not only remains widespread, but also has garnered increasing support...
  15. ncbi Radiolabeled cell distribution after intramyocardial, intracoronary, and interstitial retrograde coronary venous delivery: implications for current clinical trials
    Dongming Hou
    Indiana University School of Medicine, Indianapolis, IN, USA
    Circulation 112:I150-6. 2005
    ..We evaluated the short-term fate of peripheral blood mononuclear cells (PBMNCs) after intramyocardial (IM), intracoronary (IC), and interstitial retrograde coronary venous (IRV) delivery in an ischemic swine model...
  16. ncbi Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the Prostate-Specific Antigen Working Group
    Howard I Scher
    Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA
    J Clin Oncol 22:537-56. 2004
    ..To define methodology to show clinical benefit for patients in the state of a rising prostate-specific antigen (PSA)...
  17. ncbi Quantitative real-time polymerase chain reaction for malaria diagnosis and its use in malaria vaccine clinical trials
    Laura Andrews
    Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK
    Am J Trop Med Hyg 73:191-8. 2005
    ..A large variety of potential vaccines are under investigation worldwide, and when tested in clinical trials, researchers need to extract as much data as possible from every vaccinated and control volunteer...
  18. pmc Clinical trials in head injury
    Raj K Narayan
    Department of Neurosurgery, Temple University Hospital, Philadelphia, Pennsylvania 19140, USA
    J Neurotrauma 19:503-57. 2002
    ..Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform...
  19. ncbi The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials
    Sharon Mannheimer
    Harlem Hospital and Columbia University, New York, NY, USA
    Clin Infect Dis 34:1115-21. 2002
    ..biologic outcomes for human immunodeficiency virus (HIV)-infected participants in 2 randomized, multicenter clinical trials. For the period from baseline to month 12 of the study, participants who reported adherence levels of 100%, ..
  20. ncbi The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials
    Duncan J Macrae
    Pediatric Intensive Care Unit, Royal Brampton Hospital, London, UK
    Proc Am Thorac Soc 4:176-8, discussion 178-9. 2007
    ..professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war ..
  21. pmc The assessment of antiangiogenic and antivascular therapies in early-stage clinical trials using magnetic resonance imaging: issues and recommendations
    M O Leach
    Cancer Research UK Clinical Magnetic Resonance Research Group, Institute of Cancer Research, Royal Marsden Hospital, Sutton, Surrey, UK
    Br J Cancer 92:1599-610. 2005
    ..imaging is being used increasingly to noninvasively monitor the action of these therapeutics in early-stage clinical trials. This publication reports the outcome of a workshop that considered the methodology and design of magnetic ..
  22. ncbi Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes
    Jonathan J Deeks
    Centre for Statistics in Medicine, Institute of Health Sciences, Old Road, Headington, Oxford OX3 7LF, UK
    Stat Med 21:1575-600. 2002
    ..The appropriate selection for a particular meta-analysis may depend on understanding reasons for variation in control group event rates; in some situations uncertainty about the choice of summary statistic will remain...
  23. ncbi Participation in cancer clinical trials: race-, sex-, and age-based disparities
    Vivek H Murthy
    Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Conn 06520, USA
    JAMA 291:2720-6. 2004
    Despite the importance of diversity of cancer trial participants with regard to race, ethnicity, age, and sex, there is little recent information about the representation of these groups in clinical trials.
  24. ncbi Automatic "pipeline" analysis of 3-D MRI data for clinical trials: application to multiple sclerosis
    Alex P Zijdenbos
    McConnell Brain Imaging Centre, Montreal Neurological Institute, McGill University, 3801 University Street, WB 208, Montreal, QC H3A 2B4, Canada
    IEEE Trans Med Imaging 21:1280-91. 2002
    ..While useful for clinical trial analysis in multiple sclerosis, this system holds widespread potential for applications in other neurological disorders, as well as for the study of neurobiology in general...
  25. ncbi Participation of patients 65 years of age or older in cancer clinical trials
    Joy H Lewis
    RAND Health, Santa Monica, CA 90407 2138, USA
    J Clin Oncol 21:1383-9. 2003
    ..occur among the elderly, recent studies indicate that the elderly comprise only 25% of participants in cancer clinical trials. Further investigation into the reasons for low elderly participation is warranted...
  26. ncbi Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy
    Sean R Tunis
    Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Baltimore, MD 21244, USA
    JAMA 290:1624-32. 2003
    ..exist in the production of scientific evidence, in part because there is no consistent effort to conduct clinical trials designed to meet the needs of decision makers...
  27. ncbi Multivariable modelling for meta-epidemiological assessment of the association between trial quality and treatment effects estimated in randomized clinical trials
    V Siersma
    Department of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, entr B, P O Box 2099, Copenhagen DK 1014, Denmark
    Stat Med 26:2745-58. 2007
    ..A multilevel approach also avoids instabilities and addresses the more fundamental problem of interpretation of the pooled multivariable effect in the presence of heterogeneity...
  28. pmc Co-ordinating 'ethical' clinical trials: the role of research coordinators in the contract research industry
    Jill A Fisher
    Women and Gender Studies Program, Arizona State University, AZ 85287, USA
    Sociol Health Illn 28:678-94. 2006
    Change in the way new drugs are developed, including the privatisation of clinical trials, has altered the arrangement and roles of healthcare professions...
  29. pmc Integrating behavioral and social science research into microbicide clinical trials: challenges and opportunities
    Elizabeth E Tolley
    Family Health International, 2224 East NC 54, Durham, NC 27713, USA
    Am J Public Health 96:79-83. 2006
    ..We found that behavioral and social science research can both support microbicide clinical trial performance and anticipate the information most needed for a rapid and successful introduction of future microbicide products...
  30. ncbi Maximizing retention in community-based clinical trials
    Linda Lindsey Davis
    Room 410, School of Nursing, 1701 University Blvd, University of Alabama at Birmingham, Birmingham, AL 35294 1210, USA
    J Nurs Scholarsh 34:47-53. 2002
    To identify and discuss retention strategies and their effectiveness in community-based clinical trials in the last decade.
  31. ncbi Pregnancy outcomes following exposure to serotonin reuptake inhibitors: a meta-analysis of clinical trials
    Roja Rahimi
    Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran
    Reprod Toxicol 22:571-5. 2006
    ..Our results find that SRIs do not increase the risk of major, cardiovascular and minor malformations but do increase the risk of spontaneous abortion significantly...
  32. ncbi Diffuse brainstem glioma in children: critical review of clinical trials
    Darren Hargrave
    Department of Paediatric Oncology, Royal Marsden Hospital, Sutton, Surrey, UK
    Lancet Oncol 7:241-8. 2006
    ..Many clinical trials have been done over the past three decades, but survival has remained static...
  33. ncbi Quantitative sensory testing: a comprehensive protocol for clinical trials
    R Rolke
    Institute of Physiology and Pathophysiology, Johannes Gutenberg University, Saarstr 21, D 55099 Mainz, Germany
    Eur J Pain 10:77-88. 2006
    ..Case examples of selected patients illustrate the value of z-transformed QST data for an easy survey of individual symptom profiles...
  34. ncbi Issues in the registration of clinical trials
    Deborah A Zarin
    National Library of Medicine, National Institutes of Health, US Department of Health and Human Services, Bethesda, MD, USA
    JAMA 297:2112-20. 2007
    Public concerns about the perils associated with incomplete or delayed reporting of results from clinical trials has heightened interest in trial registries and results databases...
  35. ncbi Health related quality of life outcomes in cancer clinical trials
    A Bottomley
    EORTC Data Center, Quality of Life Unit, avenue E Mounier, 83, 1200 Brussels, Belgium
    Eur J Cancer 41:1697-709. 2005
    ..published by the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest clinical trials organisations in Europe...
  36. ncbi Development of a recombinant Leishmania major strain sensitive to ganciclovir and 5-fluorocytosine for use as a live vaccine challenge in clinical trials
    Noushin Davoudi
    Department of Biotechnology, Pasteur Institute of Tehran, Pasteur Square, Tehran, Iran
    Vaccine 23:1170-7. 2005
    ..major (tk-cd+/+), were completely cured by 2 weeks of treatment with either drug alone or in combination. Treated animals showed no signs of reoccurrence of infection for at least 4 months when the experiments were terminated...
  37. ncbi European Society of Cardiology and American College of Cardiology guidelines for redefinition of myocardial infarction: how to use existing assays clinically and for clinical trials
    Fred S Apple
    Department of Laboratory Medicine and Pathology, Hennepin County Medical Center and University of Minnesota School of Medicine, Minneapolis, Minn, USA
    Am Heart J 144:981-6. 2002
    ..The Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial asked for recommendations concerning the use of troponin assays for the trial...
  38. ncbi Meta-analyses of clinical trials in patients with non-small cell lung cancer. Minireview
    V Kovac
    Institute of Oncology, SI 1000 Ljubljana, Slovenia
    Neoplasma 51:334-40. 2004
    ..The review of meta-analyses of clinical trials we had made showed that --in radically operated patients the postoperative radiotherapy should be detrimental ..
  39. ncbi Clinical trials with oncolytic adenovirus in China
    Wang Yu
    Department of Medical Affairs, Shanghai Sunway Biotech Co, Ltd, China
    Curr Cancer Drug Targets 7:141-8. 2007
    ..step with that in other countries and even accelerated the process in some fields, especially in conducting clinical trials. H101 is one kind of oncolytic adenovirus with E1B-55KD and partial E3 deleted developed by Shanghai ..
  40. ncbi Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials
    Carol A Townsley
    FRCPC, Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, 610 University Ave, Suite 5 210, Toronto, Ontario, M5G 2M9, Canada
    J Clin Oncol 23:3112-24. 2005
    Older patients are significantly underrepresented in cancer clinical trials. A literature review was undertaken to identify the barriers that impede the accrual of this vulnerable population onto clinical trials and to determine what ..
  41. ncbi Clinical effectiveness of contemporary adhesives: a systematic review of current clinical trials
    M Peumans
    Leuven BIOMAT Research Cluster, Department of Conservative Dentistry, School of Dentistry, Oral Pathology and Maxillo Facial Surgery, Catholic University of Leuven, Leuven, Belgium
    Dent Mater 21:864-81. 2005
    ..Restoration retention in function of time was recorded in order to find out if adhesives with a simplified application procedure are as clinically effective as conventional three-step adhesives...
  42. pmc EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis
    Bernhard Hellmich
    Department of Rheumatology, University Hospital of Schleswig Holstein, Campus Lubeck, Lubeck, Germany
    Ann Rheum Dis 66:605-17. 2007
    To develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis.
  43. ncbi Sensitivity to changes in disability after stroke: a comparison of four scales useful in clinical trials
    Alexander W Dromerick
    Department of Neurology and Program in Occupational Therapy, Washington University School of Medicine, St Louis, MO 63110, USA
    J Rehabil Res Dev 40:1-8. 2003
    ..Though ADL scales may take longer to administer, their increased sensitivity may make them more useful in treatment trials by allowing fewer subjects to be enrolled...
  44. ncbi Statistical heterogeneity in systematic reviews of clinical trials: a critical appraisal of guidelines and practice
    Julian Higgins
    MRC Biostatistics Unit, Institute of Public Health, Robinson Way, Cambridge CB2 2SR, UK
    J Health Serv Res Policy 7:51-61. 2002
    Heterogeneity between study results can be a problem in any systematic review or meta-analysis of clinical trials. Identifying its presence, investigating its cause and correctly accounting for it in analyses all involve difficult ..
  45. ncbi Accreditation and quality assurance for Radiation Therapy Oncology Group: Multicenter clinical trials using Stereotactic Body Radiation Therapy in lung cancer
    Robert Timmerman
    Department of Radiation Oncology, The University of Texas Southwestern Medical Center, Dallas, TX 75390 9183, USA
    Acta Oncol 45:779-86. 2006
    ..The development of RTOG 0618 using SBRT in operable patients with early stage NSCLC is a testament to both the enthusiasm from already published works and prospective multicenter clinical testing using SBRT techniques...
  46. ncbi Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors
    Edward J Mills
    Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
    Lancet Oncol 7:141-8. 2006
    Enrolling participants onto clinical trials of cancer presents an important challenge. We aimed to identify the concerns of patients with cancer about, and the barriers to, participation in clinical trials.
  47. ncbi The method of minimization for allocation to clinical trials. a review
    Neil W Scott
    Department of Public Health, University of Aberdeen, Aberdeen, UK
    Control Clin Trials 23:662-74. 2002
    Minimization is a largely nonrandom method of treatment allocation for clinical trials. We conducted a systematic literature search to determine its advantages and disadvantages compared with other allocation methods...
  48. ncbi Clinical trials in cancer prevention: current results and perspectives for the future
    Peter Greenwald
    Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA
    J Nutr 134:3507S-3512S. 2004
    ..Progress in cancer prevention has been accelerated as prevention clinical trials are completed and reported...
  49. ncbi Use of health-related quality of life in prescribing research. Part 2: methodological considerations for the assessment of health-related quality of life in clinical trials
    M J Calvert
    Department of Primary Care and General Practice, University of Birmingham, Birmingham, UK
    J Clin Pharm Ther 29:85-94. 2004
    ..In addition we consider ways to minimize bias within the trial through optimization of compliance and timing of assessments...
  50. ncbi Modified National Institutes of Health Stroke Scale for use in stroke clinical trials: prospective reliability and validity
    Brett C Meyer
    Department of Neurosciences, UCSD School of Medicine, San Diego, Calif 92103 8466, USA
    Stroke 33:1261-6. 2002
    ..We sought to prospectively measure the reliability and validity of the mNIHSS...
  51. ncbi Validation of CADESI-03, a severity scale for clinical trials enrolling dogs with atopic dermatitis
    Thierry Olivry
    Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA
    Vet Dermatol 18:78-86. 2007
    ..In the last 30 years, numerous clinical trials testing the efficacy of anti-inflammatory drugs have been reported, but there has been a lack of consistency ..
  52. ncbi Clinical trials and the response rate illusion
    Irving Kirsch
    Psychology, University of Hull, Hull HU6 7RX, United Kingdom
    Contemp Clin Trials 28:348-51. 2007
    ..Response rates based on continuous data do not add information, and they can create an illusion of clinical effectiveness...
  53. pmc Guideline-defining asthma clinical trials of the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network and Childhood Asthma Research and Education Network
    Loren C Denlinger
    Department of Medicine, College of Medicine, Pennsylvania State University, Hershey, PA, USA
    J Allergy Clin Immunol 119:3-11; quiz 12-3. 2007
    ..The objectives of these clinical research networks are to conduct multiple, well-designed clinical trials for rapid evaluation of new and existing therapeutic approaches to asthma and to disseminate laboratory and ..
  54. ncbi Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries
    W Stevens
    Department of Molecular Medicine and Hematology, University of Witwatersrand and National Health Laboratory Service, Saxonwold, South Africa
    Qual Assur 10:83-9. 2003
    ..accepted Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines govern the conduct of clinical trials internationally...
  55. pmc Are racial and ethnic minorities less willing to participate in health research?
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
    PLoS Med 3:e19. 2006
    ..It is widely claimed that racial and ethnic minorities, especially in the US, are less willing than non-minority individuals to participate in health research. Yet, there is a paucity of empirical data to substantiate this claim...
  56. pmc The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease
    D Charytan
    Division of Biometrics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts 02115, USA
    Kidney Int 70:2021-30. 2006
    ..Treatment of subjects with CKD should ideally be based on evidence from randomized, clinical trials, but how often subjects with CKD have been excluded from these trials is uncertain...
  57. ncbi Strategies for MMP inhibition in cancer: innovations for the post-trial era
    Christopher Mark Overall
    Department of Oral Biological and Medical Sciences, C I H R Group in Matrix Dynamics, University of British Columbia, V6T 1Z3, Canada
    Nat Rev Cancer 2:657-72. 2002
    ..Until recently, clinical trials with MMP inhibitors have yielded disappointing results, highlighting the need for better insight into the ..
  58. ncbi Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update
    Michael Schachter
    Department of Clinical Pharmacology, National Heart and Lung Institute, Imperial College School of Medicine, St Mary s Hospital, London, W2 4NY, UK
    Fundam Clin Pharmacol 19:117-25. 2005
    ..Consideration of the differences between the statins helps to provide a rational basis for their use in clinical practice...
  59. ncbi Measures of abstinence in clinical trials: issues and recommendations
    John R Hughes
    Department of Psychiatry, Psychology and Family Practice University of Vermont, Burlington 05401 1419, USA
    Nicotine Tob Res 5:13-25. 2003
    ..Trials that use short-term follow-ups (< or = 3 months) to demonstrate possible efficacy should report a prolonged abstinence measure of > or = 4 weeks. We again recommend a 2-week grace period; however, that period can vary...
  60. ncbi Natural health product-drug interactions: a systematic review of clinical trials
    Edward Mills
    Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
    Ther Drug Monit 27:549-57. 2005
    ..This paper aims to identify all clinical trials of NHP-drug interactions...
  61. ncbi Measuring costs: administrative claims data, clinical trials, and beyond
    Ruth Etzioni
    Fred Hutchinson Cancer Research Center, Seattle, Washington, USA
    Med Care 40:III63-72. 2002
    ..Accurate estimation of medical care costs raises a host of issues, both practical and methodological...
  62. ncbi Dentine hypersensitivity in subjects recruited for clinical trials: clinical evaluation, prevalence and intra-oral distribution
    D G Gillam
    Department of Periodontology, University College London UCL, University of London, London, UK
    J Oral Rehabil 29:226-31. 2002
    ..on the frequency, distribution and severity of dentine hypersensitivity (DH) in subjects recruited for clinical trials of desensitizing agents. Potential subjects (n= 48 M, 81 F, mean age 35...
  63. pmc A systematic review of systematic reviews of homeopathy
    E Ernst
    Department of Complementary Medicine, School of Sport and Health Sciences, University of Exeter, 25 Victoria Park Road, Exeter EX2 4NT UK
    Br J Clin Pharmacol 54:577-82. 2002
    ..It is concluded that the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice...
  64. ncbi Bisphosphonates: clinical experience
    Robert E Coleman
    Academic Unit of Clinical Oncology, Cancer Research Centre, Weston Park Hospital, Whitham Road, Sheffield, England S10 2SJ, United Kingdom
    Oncologist 9:14-27. 2004
    ..b>Clinical trials investigating the benefit of bisphosphonate therapy have used a composite end point defined as a skeletal-..
  65. ncbi Effects of interrater reliability of psychopathologic assessment on power and sample size calculations in clinical trials
    Matthias J Muller
    Department of Psychiatry, University of Mainz, Germany
    J Clin Psychopharmacol 22:318-25. 2002
    ..Implications of the reliability of psychiatric assessments for sample size and power calculations in clinical trials are presented...
  66. ncbi A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials
    Darren J Clayson
    PharmaQuest Ltd, Banbury, Oxfordshire, UK
    Pharmacoeconomics 24:751-65. 2006
    ..are also paying closer attention to the use of health-related quality-of-life (HR-QOL) measures in clinical trials and to the subsequent claims that are made based on the results...
  67. ncbi Use of positron emission tomography for response assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma
    Malik E Juweid
    Department of Radiology, University of Iowa, Iowa City, IA 52242, USA
    J Clin Oncol 25:571-8. 2007
    To develop guidelines for performing and interpreting positron emission tomography (PET) imaging for treatment assessment in patients with lymphoma both in clinical practice and in clinical trials.
  68. ncbi Determination of HER2 gene amplification by fluorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab
    Noel Dybdal
    Genentech Inc, South San Francisco, CA 94080, USA
    Breast Cancer Res Treat 93:3-11. 2005
    ..The IHC protocol used was a research assay, known as the Clinical Trial Assay (CTA), developed to select women with metastatic breast cancer (MBC) for three pivotal clinical trials of trastuzumab therapy.
  69. pmc Effect of a clinical trial alert system on physician participation in trial recruitment
    Peter J Embi
    Division of General Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267 0535, USA
    Arch Intern Med 165:2272-7. 2005
    Failure to recruit a sufficient number of eligible subjects in a timely manner represents a major impediment to the success of clinical trials. Physician participation is vital to trial recruitment but is often limited.
  70. ncbi Correction of X-linked chronic granulomatous disease by gene therapy, augmented by insertional activation of MDS1-EVI1, PRDM16 or SETBP1
    Marion G Ott
    Department of Hematology Oncology, University Hospital, German Cancer Research Center, Theodor Stern Kai 7, 60590 Frankfurt, Germany
    Nat Med 12:401-9. 2006
    ....
  71. ncbi Recent clinical trials using cisplatin, carboplatin and their combination chemotherapy drugs (review)
    Teni Boulikas
    Regulon, Inc, Mountain View, CA 94043, USA
    Oncol Rep 11:559-95. 2004
    ..This review summarizes the state of the art on clinical trials published mainly in 2002 using cisplatin and carboplatin in their combinations with other anticancer drugs...
  72. ncbi Cancer in older adolescents and young adults: epidemiology, diagnosis, treatment, survival, and importance of clinical trials
    W Archie Bleyer
    The University of Texas M D Anderson Cancer Center, The University of Texas Medical School Houston, TX 77030, USA
    Med Pediatr Oncol 38:1-10. 2002
    ..In the United States, only approximately 5% of 15-25 year olds with cancer are entered onto clinical trials, in contrast to 60-65% of younger patients...
  73. ncbi Why did NMDA receptor antagonists fail clinical trials for stroke and traumatic brain injury?
    Chrysanthy Ikonomidou
    Department of Pediatric Neurology, Children s Hospital, Charité Virchow Campus, Humboldt University, Berlin, Germany
    Lancet Neurol 1:383-6. 2002
    ..antagonists)--such as selfotel, aptiganel, eliprodil, licostinel and gavestinel--failed to show efficacy in clinical trials of stroke or traumatic brain injury...
  74. ncbi Survival plots of time-to-event outcomes in clinical trials: good practice and pitfalls
    Stuart J Pocock
    Medical Statistics Unit, London School of Hygiene and Tropical Medicine, WC1E 7HT, London, UK
    Lancet 359:1686-9. 2002
    Survival plots of time-to-event data are a key component for reporting results of many clinical trials (and cohort studies). However, mistakes and distortions often arise in the display and interpretation of survival plots...
  75. ncbi Schistosomes: the road from host-parasite interactions to vaccines in clinical trials
    Andre Capron
    Unité Inserm U547, Institut Pasteur, 1 rue du Professeur Calmette, BP 245, 59019 Lille Cedex, France
    Trends Parasitol 21:143-9. 2005
    ..We also describe the long road that has allowed us to move from the identification of an anti-schistosome vaccine candidate, a 28kDa glutathione-S-transferase, to its recent evaluation in human clinical trials.
  76. ncbi Safety profile of oral and intravenous moxifloxacin: cumulative data from clinical trials and postmarketing studies
    Peter Ball
    University of St Andrews, Fife, Scotland
    Clin Ther 26:940-50. 2004
    ..Moxifloxacin is a broad-spectrum, advanced-generation fluoroquinolone that has potent activity against respiratory tract infections in adults in both oral and IV formulations...
  77. ncbi Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents
    Jennifer N Stinson
    Faculty of Nursing, University of Toronto, Hospital for Sick Children, Toronto, Ont, Canada
    Pain 125:143-57. 2006
    ..and feasibility of self-report pain intensity measures for children and adolescents for use in clinical trials evaluating pain treatments...
  78. ncbi Translation of clinical trials into clinical practice
    D G Julian
    Emeritus Professor of Cardiology, University of Newcastle upon Tyne, UK
    J Intern Med 255:309-16. 2004
    The results of well-conducted clinical trials should be translated into practice but there is good evidence that this is not happening...
  79. ncbi The role of measurement reliability in clinical trials
    John M Lachin
    The Biostatistics Center, Departments of Epidemiology and Biostatistics and Statistics, The George Washington University, Rockville, MD 20852, USA
    Clin Trials 1:553-66. 2004
    ....
  80. ncbi Using technology to address recruitment issues in the clinical trial process
    Lara Marks
    Cambridge University, Cambridge, UK
    Trends Biotechnol 20:105-9. 2002
    ..development times vary widely from drug to drug, but a drug typically spends just over 6 years going through clinical trials and regulatory processes. At least 3 years of this time is spent recruiting patients...
  81. ncbi Recommendations for standardization of clinical trials with Allergen Specific Immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce
    G W Canonica
    Allergy and Respiratory Diseases, DIMI, University of Genoa, Genoa, Italy
    Allergy 62:317-24. 2007
    ..Nevertheless, the methods and experimental designs used in clinical trials are quite heterogeneous and there is no unanimously accepted methodological standard...
  82. ncbi From the laboratory bench to the patient's bedside: an update on clinical trials with mesenchymal stem cells
    Antonio Giordano
    Sbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, Temple University, Philadelphia, Pennsylvania, USA
    J Cell Physiol 211:27-35. 2007
    ..In this review, we discuss clinical trials based on the use of MSCs in cardiovascular diseases, such as treatment of acute myocardial infarction, ..
  83. ncbi An introduction to causal modeling in clinical trials
    Scarlett L Bellamy
    Department of Biostatistics and Epidemiology, University of Pennsylvania, School of Medicine, Philadelphia, PA 19104 6021, USA
    Clin Trials 4:58-73. 2007
    ..We review and compare two causal modeling approaches that correspond to two major and distinct classes of inference - efficacy and intervention-based inference - in the context of randomized trials with subject noncompliance...
  84. ncbi Gene therapy: therapeutic gene causing lymphoma
    Niels Bjarne Woods
    Laboratory of Genetics, The Salk Institute for Biological Studies, La Jolla, California 92037, USA
    Nature 440:1123. 2006
    ..Gene-therapy trials for X-SCID, which have been based on the assumption that IL2RG is minimally oncogenic, may therefore pose some risk to patients...
  85. ncbi Racial differences in factors that influence the willingness to participate in medical research studies
    Vickie L Shavers
    Department of Epidemiology, University of Iowa, Iowa City, IA, USA
    Ann Epidemiol 12:248-56. 2002
    ..We examined racial differences in the prevalence of sociocultural barriers as a possible explanation for the underrepresentation of African Americans in medical research studies...
  86. ncbi Ancillary therapy and supportive care of chronic graft-versus-host disease: national institutes of health consensus development project on criteria for clinical trials in chronic Graft-versus-host disease: V. Ancillary Therapy and Supportive Care Working
    Daniel Couriel
    University of Texas MD Anderson Cancer Center, Houston, 77030, USA
    Biol Blood Marrow Transplant 12:375-96. 2006
    ..Optimal care of patients with chronic GVHD often requires a multidisciplinary approach...
  87. ncbi Non-bleeding side effects of clopidogrel: have large multi-center clinical trials underestimated their incidence?
    Zakaria A Almsherqi
    Int J Cardiol 117:415-7. 2007
    Large multi-center clinical trials have indicated significant clinical benefits for patients with atherosclerotic vascular diseases receiving clopidogrel therapy...
  88. pmc Variability of spirometry in chronic obstructive pulmonary disease: results from two clinical trials
    Laura B Herpel
    The Johns Hopkins University School of Medicine, Division of Pulmonary and Critical Care Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA
    Am J Respir Crit Care Med 173:1106-13. 2006
    ..This may be applied to determine criteria that can be used to assess a clinically meaningful change in spirometry...
  89. ncbi Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials
    Gabriel Y Lai
    Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Welch 615 N Wolfe St E6531, Baltimore, MD 21205, USA
    Clin Trials 3:133-41. 2006
    ....
  90. ncbi Interpreting clinical trials in lung cancer: impact of methodology and endpoints
    Richard J Gralla
    New York Lung Cancer Alliance, New York, New York 10024, USA
    J Thorac Oncol 2:S51-8. 2007
    The design and analysis of clinical trials are crucial if we are confidently to answer important questions regarding the treatment of patients with non-small cell lung cancer...
  91. ncbi National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report
    Paul J Martin
    Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, Washington 98109 1024, USA, and Hopital St Louis, Paris, France
    Biol Blood Marrow Transplant 12:491-505. 2006
    ..GVHD) and the lack of established research methods have made it difficult to design, conduct, and analyze clinical trials involving subjects with this disease, even when promising treatment options are available...
  92. ncbi Managing conflicts of interest in the conduct of clinical trials
    Karine Morin
    Council on Ethical and Judicial Affairs, Ethics Standards Group, American Medical Association, 515 N State St, Chicago, IL 60610, USA
    JAMA 287:78-84. 2002
    ..Some of the recent trends may accelerate the research process, particularly when large clinical trials are required...
  93. ncbi Some issues with composite endpoints in clinical trials
    George Y H Chi
    Johnson and Johnson Pharmaceutical Research and Development, L L C, Room 2604, 920 Route 202 S, Box 300, Raritan, NJ 08569, USA
    Fundam Clin Pharmacol 19:609-19. 2005
    ..the current usage of composite endpoints as primary endpoints for demonstrating the efficacy of new drugs in clinical trials. The discussion focuses on time-to-event composite endpoints...
  94. ncbi The impact of mid-treatment MRI on defining boost volumes in the radiation treatment of glioblastoma multiforme
    Rafael Manon
    University of Wisconsin, Department of Radiation Oncology, K4 B100, 600 Highland Ave, Madison, WI 53792, USA
    Technol Cancer Res Treat 3:303-7. 2004
    ....
  95. ncbi Clinical trials in Russia and Eastern Europe: recruitment and quality
    P Platonov
    Lund University, Lund, Sweden
    Int J Clin Pharmacol Ther 41:277-80. 2003
    To review the current situation of clinical trials in Russia and Eastern Europe.
  96. ncbi Metabolomics-based systems biology and personalized medicine: moving towards n = 1 clinical trials?
    Jan van der Greef
    TNO Systems Biology, Netherlands Organization for Applied Scientific Research, P O 360, 2700 AJ Zeist, Netherlands
    Pharmacogenomics 7:1087-94. 2006
    ....
  97. ncbi Early heartburn relief with proton pump inhibitors: a systematic review and meta-analysis of clinical trials
    Kenneth R McQuaid
    Department of Medicine, University of California San Fransisco, CA, USA
    Clin Gastroenterol Hepatol 3:553-63. 2005
    ..Proton pump inhibitors (PPIs) are often taken for short-term treatment of heartburn. We performed a systematic review of the efficacy of PPIs for heartburn relief within the first 1-2 days of therapy...
  98. ncbi The endothelin axis: emerging role in cancer
    Joel Nelson
    University of Pittsburgh School of Medicine, 5200 Centre Avenue, Pittsburgh, PA 15232, USA
    Nat Rev Cancer 3:110-6. 2003
    ..Preliminary results from clinical trials, such as those with atrasentan--an ET(A)-receptor antagonist--in prostate cancer, are encouraging...
  99. ncbi The Bech-Rafaelsen Melancholia Scale (MES) in clinical trials of therapies in depressive disorders: a 20-year review of its use as outcome measure
    P Bech
    Psychiatric Research, Unit WHO Collaborating Centre for Mental Health, Frederiksborg General Hospital, Denmark
    Acta Psychiatr Scand 106:252-64. 2002
    To evaluate the psychometric properties of the Bech-Rafaelsen Melancholia Scale (MES) by reviewing clinical trials in which it has been used as outcome measure.
  100. ncbi Plasmapheresis in thrombotic microangiopathy-associated syndromes: review of outcome data derived from clinical trials and open studies
    Hans von Baeyer
    Dialysepraxis Tiergarten, Berlin, Germany
    Ther Apher 6:320-8. 2002
    ..Two randomized clinical trials were performed in order to demonstrate the superiority of plasma exchange/fresh frozen plasma (PEX/FFP) over ..
  101. ncbi Professional fluoride varnish treatment for caries control: a systematic review of clinical trials
    Lars G Petersson
    Department of Community and Preventive Dentistry, Oral Maxillo facial Unit, Central Hosptial, Halmstad, Sweden
    Acta Odontol Scand 62:170-6. 2004
    ..Out of 302 identified papers, 24 randomized and controlled clinical trials comparing fluoride varnish with placebo, no active treatment or other fluoride preventive regimens of at ..

Research Grants75

  1. STATISITICAL DESIGN, MONITORING &COORD. OF VISION CLINICAL TRIALS &EPIDEMIOLOGY
    Keri Hammel; Fiscal Year: 2013
    This contract is designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies...
  2. STATISITICAL DESIGN, MONITORING &COORD. OF VISION CLINICAL TRIALS &EPIDEMIOLOGY
    Keri Hammel; Fiscal Year: 2012
    This contract is designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies...
  3. Personalized Clinical Diagnostics and Beyond: Integrated Ring Resonator Arrays
    Ryan Bailey; Fiscal Year: 2009
    ..This technology promises to broadly impact the landscape of the biomedical sciences, both meeting the clinical diagnostic challenges of today and pioneering the paradigm-shifting discoveries of tomorrow. ..
  4. Sutureless Laparoscopic Partial Nephrectomy Using Laser Tissue Welding: Preclinic
    Yasmin Wadia; Fiscal Year: 2013
    ..Under a phase II SBIR our company has commenced human clinical trials for the liver resections under a FDA IDE approval. Fast Track Phase I: Specific Aims* (Time: 6 months) 1...
  5. CFI Pathogen Inactivation Technology
    Trevor P Castor; Fiscal Year: 2010
    ..Red Cross, DOD or NHLBI, we plan to conduct pre-clinical studies, file an IND with the FDA and conduct clinical trials on CFI-treated plasma...
  6. Human embryonic stem cell-derived neural crest stem cells and Hirschsprung disea
    Sean J Morrison; Fiscal Year: 2010
    ..System Diseases/*therapy</keyword;keyword>Cerebrovascular Accident/therapy</keyword;keyword>Clinical Trials</keyword;keyword>Epilepsy/therapy</keyword;keyword>Humans</keyword;keyword>Huntington ..
  7. Anti-tumor properties of curcumin in oral cancers: role of thioredoxin reductase
    STEPHEN WILLIAM TUTTLE; Fiscal Year: 2010
    ..Chemical inhibitors of TxRd have yielded promising results in preclinical and clinical trials as cancer therapeutics and radiation sensitizers...
  8. Vaccine Development for Falciparum Malaria in Pregnant Women and Their Offspring
    Ian C Michelow; Fiscal Year: 2013
    ..Candidate vaccine proteins will be screened, confirmed and selected for clinical trials using pioneering molecular tools and blood samples from pregnant African women and their infants.
  9. Bone Deficits and Excess Adiposity after Pediatric Bone Marrow Transplantation
    Sogol Mostoufi-Moab; Fiscal Year: 2013
    ..The overarching goal of this proposal is to identify therapeutic targets, and inform future clinical trials to treat these complications...
  10. Enhanced iron removal with peptide linked chelators targeted to ferritin
    Elizabeth C Theil; Fiscal Year: 2010
    ..will lay the foundation for iron chelation studies in animal models, wild type or SCD or THL, and later for clinical trials to improve the treatment of Sickle Cell Disease and Thalassemia and possibly for neurodegenerative diseases ..
  11. FASEB SRC on Lysophospholipd Mediators in Health and Disease
    Julie D Saba; Fiscal Year: 2011
    ..and discuss novel findings regarding lysophospholipid metabolism, signaling, regulation, pharmacology and clinical trials;2) to facilitate participation of early career investigators;3) to promote participation of women and ..
  12. Effective treatment of sleep apnea in prediabetes to reduce cardiometabolic risk
    Esra Tasali; Fiscal Year: 2010
    ..The results are expected to provide essential information for the design of future large clinical trials that will determine whether treatment of OSA, in addition to lifestyle modifications, could be a first line ..
  13. Effects of Testosterone and Genetic Factors on Psychological and Motor Function i
    NICOLE RENEE TARTAGLIA; Fiscal Year: 2013
    ..and behavior in children with sex chromosomal disorders and other neurogenetic syndromes, and in conducting clinical trials to develop evidence-based treatments to improve medical and psychological outcomes of children...
  14. Retinoid and Carotenoid Depletion in Patients at High-Risk for Liver Cancer
    Peter H Gann; Fiscal Year: 2010
    ..However, before safe and effective clinical trials aimed at repleting vitamin A and carotenoid stores in high-risk patients can be designed, we need exploratory ..
  15. Development of a Nonpsychotropic Cannabinoid Agonist for the Treatment of Sclerod
    Robert B Zurier; Fiscal Year: 2012
    ..owner of the IP around ajulemic acid and its uses, and is planning to advance a twice-a-day formulation into clinical trials for the treatment of patients with scleroderma, a life-threatening disease...
  16. Development of VN/14-1 and Related Analogs for Breast Cancer Therapy
    VINCENT COLLINS OFUKA NJAR; Fiscal Year: 2013
    ..by the PI of this application recently received FDA investigational new drug (IND) approval for phase I/II clinical trials in prostate cancer patients...
  17. Cystathionine beta synthase (CBS) and angiogenesis
    Priyabrata Mukherjee; Fiscal Year: 2013
    ..Importantly, several large-scale randomized clinical trials (RCTs) demonstrated that although the vitamin supplementation lowered the plasma Hcy levels, but it failed to ..
  18. Right ventricular contractile dysfunction after pressure overload
    CLIFFORD RUSSELL GREYSON; Fiscal Year: 2013
    ..Specific Aim 4: Determine whether protease or protein kinase inhibitors currently in clinical trials can attenuate right heart failure in acute RV pressure overload...
  19. Immunomodulatory and regenerative effects of mesenchymal stem cells on allografts
    Norma S Kenyon; Fiscal Year: 2013
    ..the optimal MSC source, coupled with prospective monitoring of potential biomarkers, in order to enable pilot clinical trials of islet or renal/MSC co-transplantation...
  20. DNA Damage and Response in the Bladder Microenvironment.
    Bradley P Dixon; Fiscal Year: 2013
    ..The Candidate's long-term goals are to explore the translational aspect of this work in clinical trials aimed at the reduction of bladder cancer in patients with bladder augmentations and to become an independent ..
  21. Mucosal Immunity, Vaccines and Microbiota Interplay in Humans and Animal
    Marcelo B Sztein; Fiscal Year: 2013
    ..dysenteriae 1 in clinical trials to advance vaccine development, a nonhuman primate model is urgently needed...
  22. N-methanocarbathymidine (N-MCT) for the Treatment of Herpes and Pox Virus Infecti
    Aquilur Rahman; Fiscal Year: 2010
    ..unique pharmacological characteristics suggest that N-MCT would be an ideal candidate for further preclinical studies that lead to an IND and clinical trials, and the funds sought will help significantly in furthering its development.
  23. Induction and maintenance of regulatory T cells
    Mitchell Kronenberg; Fiscal Year: 2013
    ..of this group have complementary areas of expertise ranging from gene transcription studies to the set up of clinical trials. They work in relevant animal models of infection and immune mediated diseases such as type I diabetes, ..
  24. Statin modulation of immunotherapy for Alzheimer disease
    Jun Tan; Fiscal Year: 2012
    ..b>Clinical trials of this therapy were halted because of brain inflammation in subset of cases...
  25. BIOCHEMISTRY OF PRE-MRNA SPLICING
    Adrian R Krainer; Fiscal Year: 2010
    ..Some of these approaches are already being tested in clinical trials for muscular dystrophy and spinal muscular atrophy, while others are still in the pre-clinical stages...
  26. Inhibition of IkK to treat lethal Graft-vs.-Host Disease
    Patrick Flood; Fiscal Year: 2009
    ..If this phase II grant is successful, it will pave the way for clinical trials of this therapy at the University of North Carolina at Chapel Hill...
  27. Oklahoma Autoimmunity Center of Excellence
    Judith A James; Fiscal Year: 2013
    ..In addition, two clinical trials are proposed;both of which enhance or build upon the basic science projects...
  28. Mitochondrial dysfunction, oxidative stress, and surgical acute kidney injury
    FREDERIC TREMAINE BILLINGS; Fiscal Year: 2013
    ..Aims) and 2) Gain the skills and experiences required to become an independent investigator conducting clinical trials that test therapy for and mechanisms of surgery-induced AKI...
  29. Alpha B crystallin as a novel therapeutic for SIRS and Sepsis
    Jonathan B Rothbard; Fiscal Year: 2011
    ..Over 30 different clinical trials of anti-inflammatory agents have failed during the past twenty years...
  30. Model of Timothy Syndrome to Screen Drugs with Induced Pluripotent Stem Cells
    Masayuki Yazawa; Fiscal Year: 2013
    ..Drug-induced LQTS is a side effect of many drugs that have approved and is a common cause of drug failure in clinical trials. Though many of the genes are reported to cause LQTS, the mechanisms underlying the disease in humans are ..
  31. Model of Timothy Syndrome to Screen Drugs with Induced Pluripotent Stem Cells
    Masayuki Yazawa; Fiscal Year: 2013
    ..Drug-induced LQTS is a side effect of many drugs that have approved and is a common cause of drug failure in clinical trials. Though many of the genes are reported to cause LQTS, the mechanisms underlying the disease in humans are ..
  32. Clinical , Mechanical and Chemical Evaluation of Amalgam and ART Restorations
    Lilliam Marie Pinzon; Fiscal Year: 2013
    ..Results of several clinical trials conducted outside the US (US studies have not been conducted) have suggested that glass ionomer cement (GIC) ..
  33. A MicroRNA Approach to Screen for Sporadic Colon Cancer Exfoliately in Human Stoo
    Farid E Ahmed; Fiscal Year: 2010
    ..blood test is the only screening test proved to be effective in reducing CRC mortality by three randomized clinical trials (RCTs) (6-8)...
  34. Targeting iNOS to inhibit myeloid-derived suppressor cells (MDSC) in melanoma
    ANDREW GREGORY SIKORA; Fiscal Year: 2013
    ..areas targeted for improvement (biostatistics, clinical research skills and translation of basic findings to clinical trials)...
  35. Novel, Rapidly Translatable Technologies for Healing Long Bone Segmental Defects
    Christopher H Evans; Fiscal Year: 2010
    ..Its successful completion will generate considerable additional, sustained activity in the form of human clinical trials, as the technology moves into clinical application, and further pre-clinical research, as the technology is ..
  36. Alzheimer's Disease Therapeutic
    Trevor P Castor; Fiscal Year: 2012
    ..Establish a Drug Master File, design IND-enabling preclinical studies and Phase I/II clinical trials, and draft IND package: In a Phase III commercialization effort, we will conduct IND-enabling preclinical in ..
  37. Adenosine and the Basal Forebrain in the Control of Behavioral State
    Robert E Strecker; Fiscal Year: 2012
    ..b>Clinical trials of experimental medications or interventions could follow shortly thereafter via our collaborators doing ..
  38. MR Monitoring of PTC124 Treatment in DMD
    KRISTA H VANDENBORNE; Fiscal Year: 2010
    ..for patients with muscular dystrophy, therapeutic interventions have been lacking, and outcome measures for clinical trials have been limited to measures of muscle function and quality of life, serum biomarkers of muscle breakdown ..
  39. Purkinje Origin of Ischemic Ventricular Tachycardia and Fibrillation
    James B Martins; Fiscal Year: 2013
    ..Mechanisms studied herein could be pursued immediately in clinical trials since readily available drugs, statins or angiotensin converting enzyme inhibitors, may be combined for their ..
  40. Arsenic Trioxide and Acute Myeloid Leukemia
    Yongkui Jing; Fiscal Year: 2012
    ..of therapeutically achievable concentration of As2O3 with fenretinide (4-HPR), a retinoid approved for clinical trials, synergizes in causing apoptosis in AML cells which express detectable (basal or As2O3-induced) NADPH oxidase ..
  41. Bioassay for Breast Cancer Prevention
    JoEllen Welsh; Fiscal Year: 2010
    ..Unfortunately, in clinical trials, patients had late stage cancer and exhibited minimal improvement with vitamin D based therapies...
  42. Cell signaling as a leukemia biomarker
    JAMES WILLIAM JACOBBERGER; Fiscal Year: 2013
    ..Current diagnosis, therapeutic choices, and selection for clinical trials depend to some degree on genetic analysis, and in the future, this dependence will be greater...
  43. Systemic AA Amyloidosis Inhibitors
    ALAN D SNOW; Fiscal Year: 2010
    ..will help us optimize a novel small molecule compound (and its back-up) that will be developed for human clinical trials and commercialization, and that has promise to serve as a new treatment for systemic AA amyloidosis and ..
  44. N-methanocarbathymidine (N-MCT) for the Treatment of Herpes and Pox Virus Infecti
    Aquilur Rahman; Fiscal Year: 2013
    ..suggest that N-MCT will be an ideal candidate for commercial development upon completing pre-IND studies and clinical trials. This Phase II SBIR proposal will help significantly to advance the development of N-MCT towards clinical ..
  45. Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodege
    Thomas O Obisesan; Fiscal Year: 2010
    ..Results consistent with our hypotheses will form the basis for large-scale clinical trials, and the prescription of aerobic fitness to prevent or attenuate the physical, psychological and the economic ..
  46. Role of Glutathione S-Transferase P in Heart Failure
    Sumanth D Prabhu; Fiscal Year: 2013
    DESCRIPTION (provided by applicant): Although oxidative stress is a hallmark of heart failure (HF), clinical trials with antioxidants targeting first generation reactive oxygen species (ROS) such as O2/ and H2O2 have not yielded ..
  47. Autoimmunity Center of Excellence (ACE) at Stanford
    CHARLES GARRISON FATHMAN; Fiscal Year: 2013
    ..and then conducting basic and translational research into the mechanism of CD4 T cell unresponsiveness;two clinical trials that include novel therapies and mechanistic studies of these therapies for autoimmune diseases;and a pilot ..
  48. Nitric Oxide Restoration &Heme Detoxification as Adjunctive Therapies for Cerebr
    LEONARDO JOSE DE MOURA CARVALHO; Fiscal Year: 2012
    ..falciparum. We expect that to define one or more compounds that can be forwarded for clinical trials. Cerebral malaria (CM) is a major complication of infection by Plasmodium falciparum, causing hundreds of ..
  49. The Role of Vascular MR-Regulated Genes in Vascular Function and Disease
    Iris Z Jaffe; Fiscal Year: 2013
    ..In clinical trials, aldo antagonists significantly decrease cardiovascular mortality and ischemia out of proportion to modest ..
  50. Prevention of age-associated musculoskeletal loss by n-3 fatty acids
    Md Mizanur Rahman; Fiscal Year: 2013
    ..After successful animal study, my ultimate goal is to pursue clinical trials to establish these strategies to improve human health during aging...
  51. Preclinical drug trial in mouse models of inflammation
    Kanneboyina Nagaraju; Fiscal Year: 2011
    ..block in moving potential therapeutic approaches for rare diseases from the laboratory bench to human clinical trials involves obtaining "pre-clinical" data in mouse models of human disease...
  52. Efficacy of GABAA a5 receptor inverse agonists in learning impaired rats
    EARL MICHAEL GIBBS; Fiscal Year: 2010
    ..to Phase II studies that will aim to expand preclinical safety and efficacy testing ultimately leading to clinical trials. Commercialization opportunities will be realized via drug development efforts for treating mental health ..
  53. Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia after SCI
    Kenneth J Gustafson; Fiscal Year: 2012
    ..This has immediate clinical potential and wil provide justification for initiating work aimed at producing clinical trials for a non-invasive devce...
  54. Improved Adventitial Sirolimus Therapy for Peripheral Artery Restenosis
    KIRK SEWARD; Fiscal Year: 2010
    ..If these initial pilot studies are successful, we intend to move into clinical trials and ultimately seek FDA approval for a novel combination product...
  55. Clinical Development of Hemostatic Agent ClotFoam for Severe Hemorrhage
    Maja Nowakowski; Fiscal Year: 2013
    ..an Investigational New Drug Application (IND) to the Food and Drug Administration, toward the conduction of clinical trials. The goal of this project is to conduct clinical trials with the non-compressible hemostatic agent ClotFoam(R)..
  56. Mitochondrial and Nuclear Mechanisms of Estrogen Receptor-Mediated Cardioprotecti
    DONNA HOPE KORZICK; Fiscal Year: 2012
    ..mortality are also significantly greater in aged women when compared to aged men, and data from large scale clinical trials suggest that estrogen replacement therapy is ineffective in reducing, and may actually increase CVD outcomes...
  57. Regulation of vaccine-induced anti-fungal T17 cells
    MARCEL WUETHRICH; Fiscal Year: 2013
    ..Despite the growing prevalence of severe fungal infections, no vaccines against fungi are in clinical trials or commercially available...
  58. Mechanistic Studies on Prostate Cancer Prevention by Gugulipid
    Dong Xiao; Fiscal Year: 2013
    ..GL has been used in many clinical trials that have focused on its cholesterol-lowering effect and the products of standardized formulations of ..
  59. High throughput screen for selective inhibitors of cyclophilin B
    Richard J Bram; Fiscal Year: 2013
    ..There exist some small molecule inhibitors of cyclophilins, and several have been tested in clinical trials (thus far for the treatment of hepatitis)...
  60. Therapeutic Approaches for Extinction of Conditioned Drug Reward
    Gary B Kaplan; Fiscal Year: 2013
    ..approaches to extinguish drug cue and contextual reactivity in addiction and can inform the design of clinical trials for opiate abusing Veterans...
  61. Treatment of Inflammatory Bowel Disease with Ceramidase Inhibitors
    Lynn W Maines; Fiscal Year: 2012
    ..with the proposed IBD models and a proven track record for bringing sphingolipid-targeted drugs into clinical trials. We believe that the use of neutral ceramidase inhibitors for te treatment of IBD is an innovative approach ..
  62. Knockdown of Gene Expression in Immune Cells in Humanized Mice
    Judy Lieberman; Fiscal Year: 2010
    ..and hepatitis C, have not been successful;vaccines that look promising in other species often fail in human clinical trials. This proposal will develop a powerful tool that will be useful for dissecting the contribution of individual ..
  63. Anti-Idiotype Therapy of Human B Cell Malignancy
    Ronald Levy; Fiscal Year: 2007
    ..We will conduct Human Clinical Trials in which patients in their first and best remission after standard chemotherapy will be immunized with a ..
  64. GENE THERAPY FOR HEMOPHILIA
    Mark Kay; Fiscal Year: 2005
    ..We have used the information learned from this trial to develop new preclinical clinical trials. In this application, there are 3 preclinical gene therapy proposals 2 clinical trials...
  65. SUBMACULAR SURGERY TRIALS--PHOTOGRAPH READING CENTER
    Susan Bressler; Fiscal Year: 2003
    ..secondary to age-related macular degeneration, ocular histoplasmosis, and unknown causes in four randomized clinical trials, each for a different lesion type and presumed etiology...
  66. Investigation of synergy between Rifampin and SQ109, a new anti-TB drug candidate
    VENKATA REDDY; Fiscal Year: 2009
    SQ109 is a new anti-TB drug candidate that is currently undergoing Phase Ia Clinical Trials in humans. SQ109 was selected out of the library of 63,238 compounds, because it is highly efficacious in killing M...
  67. Electronic Image Trial Management System
    COLIN EDWARD RHODES; Fiscal Year: 2010
    ..FDA believes automation of data collection, submission and analysis is a critical step toward streamlining clinical trials and is considering a requirement that all clinical study data for new drug applications be submitted ..
  68. Neuroimaging-based biomarkers for two components of pain
    Edward E Smith; Fiscal Year: 2010
    ..First, biomarkers could serve as intermediate outcome measures in clinical trials and treatments, making clinical trials less costly and treatments better matched to patients'individual ..
  69. Identifying Strategies to Increase Engagement in Clinical Trials in Pediatric SCD
    Lamia P Barakat; Fiscal Year: 2010
    ..Research and specific Challenge Topic, 04-MD-101: Enhancing Recruitment and Retention of Ethnic Minorities in Clinical Trials. Sickle cell disease (SCD) is a genetic disorder affecting primarily African-Americans in the United States...
  70. In Silico Model for Acute Lung Injury Prediction and Clinical Trial Design
    Ognjen Gajic; Fiscal Year: 2010
    ..Carefully designed clinical trials have confirmed the relationships between mechanical ventilators and fluid management and their effects on ALI,..
  71. Quintiles Clinical Trial Unit for HIV/AIDS Clinical Trials Networks
    Kathleen Squires; Fiscal Year: 2009
    ..QFSI), part of the world's largest contract research organization, proposes to create and administer a Clinical Trials Unit (CTU) to conduct studies to support the research objectives of the NIAID HIV/AIDS Clinical Trials ..
  72. Nurses: Research Integrity in Clinical Trials
    Joan Liaschenko; Fiscal Year: 2003
    ..However in discussions of clinical trials, research ethics focuses nearly exclusively on the perspective of Principal Investigators...
  73. A Targeted Decision Aid to Improve Minority Participation in Clinical Trials
    MARGARET MARY BYRNE; Fiscal Year: 2010
    DESCRIPTION (provided by applicant): Randomized clinical trials are the gold standard for evaluation of medical interventions. However, recruitment of patients, particularly minorities, into trials is often difficult...
  74. DCC--INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP
    J Landis; Fiscal Year: 2003
    ..of Pennsylvania Medical Center to serve as the Data Coordinating Center (DCC) for the Interstitial Cystitis Clinical Trials Group (ICCTG)...
  75. AML Stem Cell Heterogeneity: Implications for Gemtuzumab Ozogomicin-based Therapy
    Roland Walter; Fiscal Year: 2009
    ..to become an independent investigator capable of bringing bench research to the bedside, leading appropriate clinical trials, and then using the clinical information back in the laboratory to further unravel underlying biologic ..