controlled clinical trials

Summary

Summary: Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS.

Top Publications

  1. ncbi Feasibility of placebo-controlled clinical trials of antipsychotic compounds in Europe
    W Wolfgang Fleischhacker
    Department of Biological Psychiatry, Innsbruck University Clinics, Anichstrasse 35, 6020 Innsbruck, Austria
    Psychopharmacology (Berl) 162:82-4. 2002
  2. ncbi Quality of controlled clinical trials on glaucoma and intraocular high pressure
    Javier Llorca
    Division of Preventive Medicine and Public Health, University of Cantabria School of Medicine, Santander, Spain
    J Glaucoma 14:190-5. 2005
  3. ncbi [Basic concepts in epidemiology and statistics for reading controlled clinical trials]
    Evandro Silva Freire Coutinho
    Departamento de Epidemiologia e Métodos Quantitativos em Saúde, Escola Nacional de Saude Publica
    Rev Bras Psiquiatr 27:146-51. 2005
  4. ncbi Development of the Cochrane Collaboration's CENTRAL Register of controlled clinical trials
    Kay Dickersin
    New England Cochrane Center
    Eval Health Prof 25:38-64. 2002
  5. ncbi The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials
    Brian L Burke
    Department of Psychology, Fort Lewis College, Durango, CO 81301 3999, USA
    J Consult Clin Psychol 71:843-61. 2003
  6. ncbi Responsiveness of the Acne-Specific Quality of Life Questionnaire (Acne-QoL) to treatment for acne vulgaris in placebo-controlled clinical trials
    S E Fehnel
    RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC 27709 2194, USA
    Qual Life Res 11:809-16. 2002
  7. ncbi Effect of combined caries-preventive methods: a systematic review of controlled clinical trials
    Susanna Axelsson
    The Swedish Council on Technology Assessment in Health Care, Stockholm, Sweden
    Acta Odontol Scand 62:163-9. 2004
  8. ncbi Caries-preventive effect of sodium fluoride mouthrinses: a systematic review of controlled clinical trials
    Svante Twetman
    Department of Odontology, Pediatric Dentistry, Faculty of Medicine, Umea University, SE 901 87 Umea, Sweden
    Acta Odontol Scand 62:223-30. 2004
  9. ncbi Clinical research on acupuncture. Part 2. Controlled clinical trials, an overview of their methods
    Stephen Birch
    Foundation for the Study of Traditional East Asian Medicine, Amsterdam, The Netherlands
    J Altern Complement Med 10:481-98. 2004
  10. ncbi Utility and pitfalls of some statistical methods in active controlled clinical trials
    Sue Jane Wang
    Division of Biometrics II, Office of Biostatistics, Center of Drug Evaluation and Resesarch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
    Control Clin Trials 23:15-28. 2002

Detail Information

Publications244 found, 100 shown here

  1. ncbi Feasibility of placebo-controlled clinical trials of antipsychotic compounds in Europe
    W Wolfgang Fleischhacker
    Department of Biological Psychiatry, Innsbruck University Clinics, Anichstrasse 35, 6020 Innsbruck, Austria
    Psychopharmacology (Berl) 162:82-4. 2002
    ..Most recent phase II and phase III PCTs of antipsychotics in schizophrenia have been conducted outside Europe. This development needs to be better understood...
  2. ncbi Quality of controlled clinical trials on glaucoma and intraocular high pressure
    Javier Llorca
    Division of Preventive Medicine and Public Health, University of Cantabria School of Medicine, Santander, Spain
    J Glaucoma 14:190-5. 2005
    To study the quality of controlled clinical trials on glaucoma.
  3. ncbi [Basic concepts in epidemiology and statistics for reading controlled clinical trials]
    Evandro Silva Freire Coutinho
    Departamento de Epidemiologia e Métodos Quantitativos em Saúde, Escola Nacional de Saude Publica
    Rev Bras Psiquiatr 27:146-51. 2005
    ..concepts in epidemiology and statistics needed for understanding properly the design and results of controlled clinical trials. Through a set of examples, the concepts of measures of association and effect, statistical significance ..
  4. ncbi Development of the Cochrane Collaboration's CENTRAL Register of controlled clinical trials
    Kay Dickersin
    New England Cochrane Center
    Eval Health Prof 25:38-64. 2002
    ....
  5. ncbi The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials
    Brian L Burke
    Department of Psychology, Fort Lewis College, Durango, CO 81301 3999, USA
    J Consult Clin Psychol 71:843-61. 2003
    A meta-analysis was conducted on controlled clinical trials investigating adaptations of motivational interviewing (AMIs), a promising approach to treating problem behaviors...
  6. ncbi Responsiveness of the Acne-Specific Quality of Life Questionnaire (Acne-QoL) to treatment for acne vulgaris in placebo-controlled clinical trials
    S E Fehnel
    RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC 27709 2194, USA
    Qual Life Res 11:809-16. 2002
    ..The results of this evaluation confirm that the Acne-QoL is responsive, internally consistent, and valid...
  7. ncbi Effect of combined caries-preventive methods: a systematic review of controlled clinical trials
    Susanna Axelsson
    The Swedish Council on Technology Assessment in Health Care, Stockholm, Sweden
    Acta Odontol Scand 62:163-9. 2004
    ..No conclusion could be drawn regarding the evidence for combinations of treatments being effective for groups at high caries risk, as the results from the identified clinical studies were conflicting...
  8. ncbi Caries-preventive effect of sodium fluoride mouthrinses: a systematic review of controlled clinical trials
    Svante Twetman
    Department of Odontology, Pediatric Dentistry, Faculty of Medicine, Umea University, SE 901 87 Umea, Sweden
    Acta Odontol Scand 62:223-30. 2004
    ..The need for further clinical trials to elucidate the effect of FMRs in risk patients and older adults is emphasized...
  9. ncbi Clinical research on acupuncture. Part 2. Controlled clinical trials, an overview of their methods
    Stephen Birch
    Foundation for the Study of Traditional East Asian Medicine, Amsterdam, The Netherlands
    J Altern Complement Med 10:481-98. 2004
    ..Improved trial quality will lead to greater ease interpreting the results of trials, especially in systematic reviews...
  10. ncbi Utility and pitfalls of some statistical methods in active controlled clinical trials
    Sue Jane Wang
    Division of Biometrics II, Office of Biostatistics, Center of Drug Evaluation and Resesarch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
    Control Clin Trials 23:15-28. 2002
    ....
  11. ncbi Attitudes of patients with schizophrenia toward placebo-controlled clinical trials
    Martina Hummer
    Department of Biological Psychiatry, Innsbruck University Clinics, Innsbruck, Austria
    J Clin Psychiatry 64:277-81. 2003
    ..Although much is known about the opinions of professionals concerning this issue, so far nothing is known about the opinions of patients who are most affected by the realization of placebo-controlled clinical trials.
  12. ncbi Herbal medicines for treatment of fungal infections: a systematic review of controlled clinical trials
    Karen W Martin
    Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK
    Mycoses 47:87-92. 2004
    ..This systematic review evaluates antifungal herbal preparations that have been tested in controlled clinical trials. Four electronic databases were searched for controlled clinical trials of antifungal herbal medicines...
  13. ncbi [Randomized and nonrandomized controlled clinical trials in a German surgical journal]
    M K Diener
    Deutsches Cochrane Zentrumsklinikum, Institut für Medizinische Biometrie und Medizinische Informatik, Universitatsklinikum Freiburg
    Chirurg 77:837-43. 2006
    ..The aim of this study was to assess the quantity and quality of randomized controlled (RCTs) and controlled clinical trials (CCTs) in the German surgical journal Der Chirurg.
  14. ncbi [Ethical implications of placebo-controlled clinical trials for psychotropic drugs]
    H Helmchen
    Klinik fur Psychiatrie und Psychotherapie, Charite Universitatsmedizin Berlin, Freie Universitat Berlin
    Nervenarzt 76:1319-29. 2005
    ..It is concluded that pure placebo-controlled clinical trials of new psychotropic drugs may be acceptable in minor psychic disorders, but in general -- at least in a ..
  15. ncbi Herbal medicines for treatment of bacterial infections: a review of controlled clinical trials
    Karen W Martin
    Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, 25 Victoria Park Road, Exeter EX2 4NT, UK
    J Antimicrob Chemother 51:241-6. 2003
    Many hundreds of plant extracts have been tested for in vitro antibacterial activity. This review is a critical evaluation of controlled clinical trials of herbal medicines with antibacterial activity.
  16. ncbi Is Tai Chi an effective adjunct in cancer care? A systematic review of controlled clinical trials
    Myeong Soo Lee
    Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK
    Support Care Cancer 15:597-601. 2007
    ..The aim of this systematic review is to summarize and critically evaluate the evidence available from controlled clinical trials of tai chi as a supportive therapy for cancer patients.
  17. ncbi Mistletoe in cancer - a systematic review on controlled clinical trials
    G S Kienle
    Institute for Applied Epistemology and Medical Methodology, Bad Krozingen Freiburg, Germany
    Eur J Med Res 8:109-19. 2003
    ..Mistletoe preparations are among the most widely used unconventional cancer therapies in Central Europe. Their clinical effectiveness, however, is controversial...
  18. ncbi Do anti-tumor necrosis factors induce response and remission in patients with acute refractory Crohn's disease? A systematic meta-analysis of controlled clinical trials
    Roja Rahimi
    Department of Toxicology and Pharmacology, Faculty of Pharmacy, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, P O Box 14155 6451, Tehran, Iran
    Biomed Pharmacother 61:75-80. 2007
    ..It seems that anti-tumor necrosis factors are not effective for induction of response and remission in patients with Crohn's disease...
  19. ncbi A perspective on surrogate endpoints in controlled clinical trials
    Geert Molenberghs
    Center for Statistics, Limburgs Universitair Centrum, Diepenbeek, Belgium
    Stat Methods Med Res 13:177-206. 2004
    ..Clearly statistical evidence should only be seen as a component in a decision making process that also involves a number of clinical and biological considerations...
  20. ncbi The external validity of controlled clinical trials of psychotherapy for depression and anxiety: a naturalistic study
    Kate H Morrison
    Counseling Center, University of California, Davis, CA 95616, USA
    Psychol Psychother 76:109-32. 2003
    ..for clinical practice and training to focus on empirically supported therapies tested in randomized controlled clinical trials (RCTs)...
  21. ncbi Effect of prevailing local treatment options of breast cancer on survival outside controlled clinical trials: experience of a specialist breast unit in North India
    Mallika Tewari
    Department of Surgical Oncology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India
    World J Surg 30:1794-801. 2006
    ..This study aimed at analyzing different treatments of breast cancer (BC) prevalent in the region, their effect on patients' survival, and discusses the most suitable method within available resources...
  22. ncbi Exercise and bone mineral density at the femoral neck in postmenopausal women: a meta-analysis of controlled clinical trials with individual patient data
    George A Kelley
    Department of Community Medicine, School of Medicine, West Virginia University, Morgantown, WV 26506 9190, USA
    Am J Obstet Gynecol 194:760-7. 2006
    ..We conducted a meta-analysis using individual patient data to examine the efficacy of exercise for improving bone mineral density at the femoral neck in postmenopausal women...
  23. ncbi Controlled clinical trials evaluating the homeopathic treatment of people with human immunodeficiency virus or acquired immune deficiency syndrome
    Dana Ullman
    Homeopathic Educational Services, Berkeley, CA 94704, USA
    J Altern Complement Med 9:133-41. 2003
    ....
  24. ncbi Steroid sparing in kidney transplantation: changing paradigms, improving outcomes, and remaining questions
    Joshua J Augustine
    Department of Medicine, Case Western Reserve University, Cleveland, Ohio, USA
    Clin J Am Soc Nephrol 1:1080-9. 2006
    ..Although the outcomes of kidney transplant recipients who are treated with steroid-free immunosuppression are improving steadily, there still is room for concern in recommending this strategy as a standard of practice...
  25. ncbi Where does hypnotherapy stand in the management of irritable bowel syndrome? A systematic review
    Ali Gholamrezaei
    Clinical Hypnotherapy Research Group, Medical Student Research Committee, Isfahan University of Medical Sciences IUMS, Isfahan, Iran
    J Altern Complement Med 12:517-27. 2006
    ..Despite its prevalence, there remains a significant lack of efficient medical treatment for IBS to date. However, according to some previous research studies, hypnosis has been shown to be effective in the treatment of IBS...
  26. ncbi Multiple-arm superiority and non-inferiority designs with various endpoints
    Mark Chang
    Millennium Pharmaceuticals Inc, Cambridge, MA 02139, USA
    Pharm Stat 6:43-52. 2007
    ..Application examples are provided. The effect of the contrasts on the power is discussed, and a SAS program for sample size calculation is provided and ready to use...
  27. ncbi Curative ablation for atrial fibrillation: what clinical trials do we need to establish efficacy
    Dipen Shah
    Division of Cardiology, Hopital Cantonal de Geneve, Geneva, Switzerland
    J Cardiovasc Electrophysiol 14:S48-51. 2003
    ..Atrial fibrillation burden is a theoretically robust efficacy parameter, but accurate quantification over a sufficiently long period of monitoring will require technologically innovative noninvasive rhythm monitoring devices...
  28. ncbi Placebo-controlled studies in depression: necessary, ethical and feasible
    David Baldwin
    University Department of Mental Health, Royal South Hants Hospital, Brintons Terrace, Southampton, UK
    Eur Arch Psychiatry Clin Neurosci 253:22-8. 2003
    ..Placebo-controlled studies of new antidepressants are justified, both scientifically and ethically; restrictions on placebo-controlled investigations will hinder the arrival of more efficacious and better tolerated antidepressants...
  29. ncbi The pros and cons of noninferiority trials
    Stuart J Pocock
    Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT UK
    Fundam Clin Pharmacol 17:483-90. 2003
    ....
  30. ncbi A cautionary note on design implications when the primary analysis is a stratified analysis of a binary endpoint
    Christy Chuang-Stein
    Pfizer Global Research and Development, Ann Arbor, Michigan 48105, USA
    Biom J 48:978-83. 2006
    ..The discussion in this paper is illustrated by a hypothetical example, which nevertheless resembles the findings from a confirmatory trial involving the evaluation of a biologic for severe sepsis...
  31. ncbi The efficacy of stretching for prevention of exercise-related injury: a systematic review of the literature
    S M Weldon
    Man Ther 8:141-50. 2003
    ..Randomized clinical trials (RCTs) and controlled clinical trials (CCTs) investigating stretching as an injury prevention measure were selected...
  32. ncbi Active-controlled, non-inferiority trials in oncology: arbitrary limits, infeasible sample sizes and uninformative data analysis. is there another way?
    Kevin J Carroll
    AstraZeneca Pharmaceuticals, Global Clinical Information Science, Alderley Park, Macclesfield, UK
    Pharm Stat 5:283-93. 2006
    ..Statistics in Medicine 2003; 22:239-264 and Wang and Hung Controlled Clinical Trials 2003; 24:147-155...
  33. ncbi Entangled--and tied in knots! Practical consequences of an entanglement model for homeopathic research and practice
    H Walach
    University Hospital Freiburg, Institute of Environmental Medicine and Hospital Epidemiology, Samueli Institute, European Office, D 79106 Freiburg, Germany
    Homeopathy 94:96-9. 2005
    ..Experimental proof of entanglement can only come indirectly. The implications for clinical research include that positive results will probably be found only in large series and that studies should avoid imposing a causal framework...
  34. ncbi Documentation of hip prostheses used in Norway: a critical review of the literature from 1996--2000
    Arild Aamodt
    Department of Orthopaedic Surgery, Trondheim University Hospital, Trondheim
    Acta Orthop Scand 75:663-76. 2004
    ....
  35. ncbi Types of research designs
    Deborah Winders Davis
    Department of Pediatrics, University of Louisville School of Medicine, USA
    Neonatal Netw 22:65-7. 2003
    ..Future columns will address other considerations...
  36. ncbi Catheter valves for indwelling urinary catheters: a systematic review
    Esther van den Eijkel
    Westminster Primary Care Trust, and King s College London, UK
    Br J Community Nurs 11:111-2, 114. 2006
    ..Further research into catheter valves is needed, with larger study groups, which include housebound male and female patients, and longer follow-up period...
  37. ncbi Major depressive disorder in children and adolescents: clinical trial design and antidepressant efficacy
    Graham J Emslie
    Child and Adolescent Psychiatry Division, University of Texas Southwestern Medical Center at Dallas, Dallas, USA
    J Clin Psychiatry 66:14-20. 2005
    ..about antidepressant side effects, including suicidality, it is increasingly important that clinicians who treat depressed children and adolescents make informed therapeutic decisions based on data from well-controlled clinical trials.
  38. ncbi [Impact of the quality of clinical trials in orthopedics and traumatology on the status of evidence]
    M Haake
    Aus der Orthopädischen Klinik der Universität Regensburg, Bad Abbach
    Versicherungsmedizin 56:4-10. 2004
    ..To evaluate the efficacy of any therapeutical measure, controlled clinical trials are necessary...
  39. ncbi Placebo or active control trials of antipsychotic drugs?
    W Wolfgang Fleischhacker
    Department of Biological Psychiatry, Innsbruck University Clinics, Austria
    Arch Gen Psychiatry 60:458-64. 2003
    ..Sample size requirements for various equivalence margins in noninferiority trials are provided. Scientific and ethical arguments should lead to a more frequent use of the active-control noninferiority trial design...
  40. ncbi Efficacy of solifenacin in patients with severe symptoms of overactive bladder: a pooled analysis
    R J Millard
    Department of Surgery, Prince of Wales Hospital, New South Wales, Australia
    Curr Med Res Opin 22:41-8. 2006
    ..The efficacy of antimuscarinic drug therapy in patients who have more severe symptoms of overactive bladder (OAB) at baseline has not been evaluated thoroughly...
  41. ncbi Overview on coenzyme Q10 as adjunctive therapy in chronic heart failure. Rationale, design and end-points of "Q-symbio"--a multinational trial
    Svend Aage Mortensen
    The Heart Centre, Medical Department B, Copenhagen University Hospital, Denmark
    Biofactors 18:79-89. 2003
    ..This trial should help to establish the future role of CoQ10 as part of a maintenance therapy in patients with chronic heart failure...
  42. ncbi [Evidence-based antibiotic prophylaxis in aseptic orthopedic surgery]
    K P Hunfeld
    Institut fur Medizinische Mikrobiologie, Klinikum, Johann Wolfgang Goethe Universitat, Frankfurt M
    Orthopade 32:1070-7. 2003
    ..Antibiotic administration may be repeated in the OR when surgery lasts longer than 3 h. The use of local antibiotics in bone cement has not proven useful as a prophylactic measure...
  43. ncbi Scientific evidence for pre-adjusted edgewise mechanics
    Nicola A Mandall
    Orthodontics, School of Dentistry, University of Manchester, UK
    Dent Update 34:45-6, 48, 50-1. 2007
    ..We have summarized findings from randomized and controlled clinical trials following a search of Medline and the Cochrane Clinical Trials Register (CCTR) 1970-June 2005...
  44. ncbi New developments in medical clinical trials
    R B D'Agostino
    Boston University, Mathematics and Statistics Department, Statistics and Consulting Unit, 111 Cummington St, Boston, MA 02215, USA
    J Dent Res 83:C18-24. 2004
    ..We close with a brief discussion of the unit of analysis, the role of newer statistical analysis methods, safety issues, subset analysis, and, most importantly, clinical significance...
  45. ncbi A two-stage sample size recalculation procedure for placebo- and active-controlled non-inferiority trials
    Todd A Schwartz
    Department of Biostatistics, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599 7420, USA
    Stat Med 25:3396-406. 2006
    ....
  46. ncbi Predictive probability of success and the assessment of futility in large outcomes trials
    Benjamin Trzaskoma
    Eli Lilly and Company, Lilly Corporate Center, DC 6072, Indianapolis, IN 46285, USA
    J Biopharm Stat 17:45-63. 2007
    ..We will discuss appropriate thresholds for declaring futility based on this approach, and the potential impact of overdispersion, a common phenomenon particularly in global outcomes trials...
  47. pmc The effect of acetylsalicylic acid resistance on prognosis of patients who have developed acute coronary syndrome during acetylsalicylic acid therapy
    Gultekin F Hobikoglu
    Siyami Ersek Thorax and Cardiovascular Surgery Center, Department of Cardiology, Istanbul, Turkey
    Can J Cardiol 23:201-6. 2007
    ..Thus, in the present study, the impact of AR was investigated in patients with ACS who were taking acetylsalicylic acid...
  48. ncbi Enhanced inflammatory response to coronary stenting marks the development of clinically relevant restenosis
    Adriano M Caixeta
    Division of Interventional Cardiology, Brasília Heart Institute InCor DF, Zerbini Foundation, Estrada Parque Contorno do Bosque, s n Parte, CEP 70658 900 Brasília, DF, Brazil
    Catheter Cardiovasc Interv 69:500-7. 2007
    ..The aims of this study were to investigate the effect of coronary stenting on the release of cytokines and cell-mediated immunity factors and to evaluate the association between inflammation and clinical outcomes at 6 months...
  49. ncbi Cyclosporine in the treatment of severe attack of ulcerative colitis: a systematic review
    S García-López
    Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, Spain
    Gastroenterol Hepatol 28:607-14. 2005
    ..Cyclosporine (CyA) has shown efficacy in steroid failures and could avoid surgery, but controversy remains...
  50. ncbi Choosing the analysis population in non-inferiority studies: per protocol or intent-to-treat
    M Matilde Sanchez
    Clinical Biostatistics and Research Decision Sciences, Ry34 A316, Merck Research Laboratories, P O Box 2000, Rahway, NJ 07065, USA
    Stat Med 25:1169-81. 2006
    ....
  51. ncbi Effects of warfarin on blood pressure in men with diabetes and hypertension--a longitudinal study
    Mary Ann Lim
    Department of Medicine, University of Connecticut School of Medicine, Farmington, CT, USA
    J Clin Hypertens (Greenwich) 9:256-8. 2007
    ..The results demonstrate that warfarin therapy at conventional doses does not increase systolic blood pressure or pulse pressure in patients with diabetes and hypertension...
  52. ncbi Non-parametric assessment of non-inferiority with censored data
    G Freitag
    Institut fur Mathematische Stochastik, Georg August Universitat Gottingen, Germany
    Stat Med 25:1201-17. 2006
    ..Non-inferiority over a large time period of the study can be shown in both cases...
  53. ncbi Effect of early statin treatment at standard doses on long-term clinical outcomes in patients with acute myocardial infarction (the Heart Institute of Japan, Department of Cardiology Statin Evaluation Program)
    Michitaka Nagashima
    Department of Cardiology, The Heart Institute of Japan, Tokyo Women s Medical University, Tokyo, Japan
    Am J Cardiol 99:1523-8. 2007
    ..In conclusion, these findings suggest that initiating standard rather than intensive statin therapy immediately after AMI decreases long-term mortality and subsequent cardiac events...
  54. ncbi A comparison of group sequential methods for binary longitudinal data
    Bart Spiessens
    Biostatistical Center, Catholic University of Leuven, U Z St Rafael, Kapucijnenvoer 35, B 3000 Leuven, Belgium
    Stat Med 22:501-15. 2003
    ..The comparison is illustrated with simulations using a randomized clinical trial for toenail fungal infection...
  55. ncbi No evidence that an exercise-based treatment programme (DDAT) has specific benefits for children with reading difficulties
    John P Rack
    Dyslexia Action, University of York, Heslington, UK
    Dyslexia 13:97-104; discussion 105-9. 2007
    ..Current evidence provides no support for the claim that DDAT is effective in improving children's literacy skills...
  56. ncbi Optimal design of clinical trials comparing several treatments with a control
    Ian C Marschner
    Asia Biometrics Center, Pfizer Australia, West Ryde, NSW, Australia
    Pharm Stat 6:23-33. 2007
    ..In one example a 55% reduction in sample size is achieved through an optimal design combined with the appropriate characterization of power...
  57. ncbi [Is the supplementation with antioxidants effective in the treatment of atherosclerosis?]
    St Schröder
    Medizinische Klinik, Abteilung fur Kardiologie, Eberhard Karls Universitat Tubingen
    Dtsch Med Wochenschr 129:321-6. 2004
    ..Prospective endpoint studies failed to support this hypothesis. The current literature is summarized in this review...
  58. ncbi Female sexual dysfunction in postmenopausal women: systematic review of placebo-controlled trials
    Katharina Modelska
    Prevention Sciences Group, Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA
    Am J Obstet Gynecol 188:286-93. 2003
    ..This systematic review includes all randomized and placebo-controlled trials (RCTs) of treatment for female sexual dysfunction (FSD) in postmenopausal women published since 1990...
  59. ncbi [The use of pentoxyphylline in the treatment of patients with chronic obliterative diseases of lower limb arteries]
    V M Koshkin
    Angiol Sosud Khir 11:141-7. 2005
    ..The new data are presented on its action mode as are multiple examples of the use of pentoxyphylline in the treatment of patients with peripheral angiopathies...
  60. ncbi Treatment of bipolar depression
    Steven L Dubovsky
    Department of Psychiatry, State University of New York at Buffalo, 462 Grider Street, Buffalo, NY 14215, USA
    Psychiatr Clin North Am 28:349-70, vii. 2005
    ..Considering the limitations of current knowledge is an essential component of the scientific practice of psychiatry...
  61. ncbi The current understanding of lamotrigine as a mood stabilizer
    Chang Gyu Hahn
    Department of Psychiatry, University of Pennsylvania Medical Center, Philadelphia 19104, USA
    J Clin Psychiatry 65:791-804. 2004
    ..To examine whether lamotrigine has a unique role in the treatment of bipolar disorder, we evaluated the results of recent clinical trials and molecular and cell biological studies on lamotrigine...
  62. ncbi Serotonin-norepinephrine reuptake inhibitors in the treatment of obsessive-compulsive disorder: A critical review
    Bernardo Dell'Osso
    Department of Psychiatry, Compulsive, Impulsive and Anxiety Disorders Program, Mount Sinai School of Medicine, New York, NY 10029, USA
    J Clin Psychiatry 67:600-10. 2006
    ....
  63. ncbi Meta-analysis of short-term and mid-term outcomes following off-pump coronary artery bypass grafting
    James T Reston
    Department of Health Technology Assessment, ECRI, Plymouth Meeting, Pennsylvania, USA
    Ann Thorac Surg 76:1510-5. 2003
    ..Some studies may have been too small to detect clinically important differences in patient outcomes. The present study addresses these issues using meta-analysis...
  64. ncbi Management of comorbid bipolar disorder and substance abuse
    E Sherwood Brown
    Psychoneuroendocrine Research Program, Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, USA
    J Clin Psychiatry 67:e05. 2006
    ....
  65. ncbi Representativeness of trial populations: an example from a trial of adenotonsillectomy in children
    Emma H van den Akker
    Department of Otorhinolaryngology, Wilhelmina Children s Hospital Utrecht, The Netherlands
    Acta Otolaryngol 123:297-301. 2003
    ..To compare demographic and disease-specific characteristics of children included in a trial of the effectiveness of adenotonsillectomy with those of children who, although eligible, were not randomized...
  66. ncbi Meta-analysis: evaluation of adjuvant therapy after curative liver resection for hepatocellular carcinoma
    P Mathurin
    Service d Hepatogastroenterologie, Hôpital Claude Hurriez, CHRU Lille, France
    Aliment Pharmacol Ther 17:1247-61. 2003
    ..To evaluate adjuvant modalities after curative resection for hepatocellular carcinoma using a meta-analysis of randomized and non-randomized controlled trials...
  67. pmc The effectiveness of workplace smoking cessation programmes: a meta-analysis of recent studies
    G Smedslund
    Tob Control 13:197-204. 2004
    ..Using meta-analytic procedures, we compare the effectiveness of recent controlled trials of worksite smoking cessation during the 1990s with a previous meta-analysis of programmes conducted in the 1980s...
  68. ncbi Practice parameter: temporal lobe and localized neocortical resections for epilepsy
    Jerome Engel
    Reed Neurological Research Center, Department of Neurology, Los Angeles, CA 90095 1769, USA
    Epilepsia 44:741-51. 2003
    ..To examine evidence for effectiveness of anteromesial temporal lobe and localized neocortical resections for disabling complex partial seizures...
  69. ncbi Clinical research on acupuncture. Part 1. What have reviews of the efficacy and safety of acupuncture told us so far?
    Stephen Birch
    Foundation for the Study of Traditional East Asian Medicine, Amsterdam, The Netherlands
    J Altern Complement Med 10:468-80. 2004
    ..This paper also examines conclusions from the same international reviews on the safety and adverse effects of acupuncture. Here, conclusions are more easily drawn and there is good agreement about the safety of acupuncture...
  70. ncbi Participant-centered analysis in complementary and alternative medicine comparative trials
    Mikel Aickin
    Center for Health Research, Kaiser Permanente Northwest Region, 3800 N Interstate Avenue, Portland, OR 97227 1098, USA
    J Altern Complement Med 9:949-57. 2003
    ....
  71. ncbi Chiropractic care for nonmusculoskeletal conditions: a systematic review with implications for whole systems research
    Cheryl Hawk
    Cleveland Chiropractic College, Kansas City, Missouri 64131, USA
    J Altern Complement Med 13:491-512. 2007
    ....
  72. ncbi Handsearching the EMHJ for reports of randomized controlled trials by U.K. Cochrane Centre (Bahrain)
    A Al Hajeri
    Bahrain Branch of U K Cochrane Centre, The Cochrane Collaboration, Bahrain Correspondence to A Al
    East Mediterr Health J 12:S253-7. 2006
    ..Nine reports were identified: 7 randomized controlled trials and 2 controlled clinical trials. The added value of the handsearch over EMBASE was 6 additional reports and over MEDLINE was 4...
  73. ncbi Evidence on the effectiveness of occupational health interventions
    Jani H Ruotsalainen
    Cochrane Occupational Health Field, Finnish Institute of Occupational Health, Kuopio, Finland
    Am J Ind Med 49:865-72. 2006
    ..At present there exists no overview of the range of evidence currently available regarding the effectiveness of occupational health interventions (OHI)...
  74. ncbi The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs
    Muriel Vray
    Unité d Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris, France
    Therapie 60:339-44, 345-9. 2005
    The respective roles of controlled clinical trials and observational studies (cohort or case-control studies) in evaluating the efficacy, safety and usefulness of a drug were analysed...
  75. ncbi Are better endpoints and better design of clinical trials needed?
    Jaap Fransen
    University Medical Centre Nijmegen, Department of Rheumatology, P O Box 9101, 6500 HB Nijmegen, The Netherlands
    Best Pract Res Clin Rheumatol 18:97-109. 2004
    ..When it can be measured truly and feasible, the marker would be useful as an endpoint in trials and for supporting treatment decisions in clinical practice...
  76. ncbi N-of-1 trials: innovative methods to evaluate complementary and alternative medicines in pediatric cancer
    Lillian Sung
    Department of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
    J Pediatr Hematol Oncol 28:263-6. 2006
    ..The use of N-of-1 RCTs may be very beneficial in evaluating CAM therapies in pediatric cancer. However, careful consideration of the advantages and disadvantages of such a design should be undertaken prior to initiating an N-of-1 RCT...
  77. ncbi Issues to consider when planning and conducting educational research
    Kevin W Eva
    Department of Clinical Epidemiology and Biostatistics, Programme for Educational Research and Development, McMaster University Hamilton, Ontario, Canada
    J Dent Educ 68:316-23. 2004
    ..The article focuses on quantitative methods in general with particular attention paid to experimental designs...
  78. ncbi Elective single embryo transfer following in vitro fertilization
    Jason K Min
    Ottawa ON
    J Obstet Gynaecol Can 32:363-77. 2010
    ....
  79. ncbi A systematic overview of chemotherapy effects in non-small cell lung cancer
    S Sorenson
    Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway
    Acta Oncol 40:327-39. 2001
    ..selective use in routine care of advanced NSCLC although patients should be encouraged to participate in controlled clinical trials to further elucidate the role of chemotherapy in advanced disease...
  80. ncbi Prevention of type 2 diabetes mellitus through inhibition of the Renin-Angiotensin system
    Andre J Scheen
    Division of Diabetes, Department of Medicine, Nutrition and Metabolic Disorders, CHU Sart Tilman, Liege, Belgium
    Drugs 64:2537-65. 2004
    ..Besides lifestyle changes, various pharmacological treatments have proven their efficacy in placebo-controlled clinical trials, including antidiabetic drugs such as metformin, acarbose and troglitazone, or antiobesity agents such ..
  81. ncbi Alcohol use and pregnancy consensus clinical guidelines
    George Carson
    Regina SK
    J Obstet Gynaecol Can 32:S1. 2010
    ..the last five years with the following research designs: systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no language restrictions...
  82. ncbi Benefits and risks of adjunctive inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis
    Diana M Sobieraj
    University of Connecticut School of Pharmacy, Storrs, Connecticut, USA
    Clin Ther 30:1416-25. 2008
    ....
  83. ncbi Ultrasound in twin pregnancies
    Lucie Morin
    Outremont QC
    J Obstet Gynaecol Can 33:643-56. 2011
    ..Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date restrictions...
  84. ncbi Substance use in pregnancy
    Suzanne Wong
    Toronto ON
    J Obstet Gynaecol Can 33:367-84. 2011
    ..Results were initially restricted to systematic reviews and randomized control trials/controlled clinical trials. A subsequent search for observational studies was also conducted because there are few RCTs in this ..
  85. ncbi Photodynamic therapy as adjunct to non-surgical periodontal treatment in patients on periodontal maintenance: a randomized controlled clinical trial
    Panos Chondros
    Department of Periodontology, Radboud University Medical Center, Nijmegen, The Netherlands
    Lasers Med Sci 24:681-8. 2009
    ..However, currently, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis...
  86. ncbi A systematic overview of chemotherapy effects in gastric cancer
    K G Janunger
    Department of Surgery, University Hospital, , Sweden
    Acta Oncol 40:309-26. 2001
    ..Therapy is only justified in controlled clinical trials. Published studies on the use of intraperitoneal chemotherapy are few and not conclusive regarding the ..
  87. ncbi Ovulation induction in polycystic ovary syndrome
    Tannys D R Vause
    Ottawa ON
    J Obstet Gynaecol Can 32:495-502. 2010
    ..Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies...
  88. ncbi Evaluation of prenatally diagnosed structural congenital anomalies
    Alain Gagnon
    Vancouver BC
    J Obstet Gynaecol Can 31:875-81, 882-9. 2009
    ..To provide information to genetic counsellors, midwives, nurses, and physicians who are involved in the prenatal care of women dealing with prenatally diagnosed isolated or multiple structural congenital anomalies...
  89. ncbi SOGC Clinical Practice Guideline. Ultrasonographic cervical length assessment in predicting preterm birth in singleton pregnancies
    Kenneth Lim
    Society of Obstetricians and Gynaecologists of Canada
    J Obstet Gynaecol Can 33:486-99. 2011
    ..To review (1) the use of ultrasonographic-derived cervical length measurement in predicting preterm birth and (2) interventions associated with a short cervical length...
  90. ncbi Capacity of the clinical picture to characterize low back pain relieved by facet joint anesthesia. Proposed criteria to identify patients with painful facet joints
    M Revel
    , , Paris, France
    Spine (Phila Pa 1976) 23:1972-6; discussion 1977. 1998
    ..emission computed tomography are expensive and time-consuming procedures for selecting patients in controlled clinical trials with large populations...
  91. ncbi Antibiotic therapy in preterm premature rupture of the membranes
    Mark H Yudin
    Toronto ON
    J Obstet Gynaecol Can 31:863-7, 868-74. 2009
    ..To review the evidence and provide recommendations on the use of antibiotics in preterm premature rupture of the membranes (PPROM)...
  92. ncbi Oral contraceptives and the risk of venous thromboembolism: an update
    Robert Reid
    Kingston ON
    J Obstet Gynaecol Can 32:1192-7. 2010
    ..Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies...
  93. ncbi Adverse drug interactions involving common prescription and over-the-counter analgesic agents
    Elliot V Hersh
    Department of Oral Surgery and Pharmacology, University of Pennsylvania School of Dental Medicine, Philadelphia, Pennsylvania 19104 6030, USA
    Clin Ther 29:2477-97. 2007
    ..In addition, an estimated 36 million Americans use over-the-counter (OTC) analgesics daily. Given this volume of use, it is not surprising that a number of drug interactions involving analgesic drugs have been reported...
  94. ncbi Antiviral therapy for adults with chronic hepatitis B: a systematic review for a National Institutes of Health Consensus Development Conference
    Tatyana A Shamliyan
    Minnesota Evidence based Practice Center, Division of Health Policy and Management, University of Minnesota School of Public Health, 420 Delaware Street SE, Minneapolis, MN 55455, USA
    Ann Intern Med 150:111-24. 2009
    ..Chronic hepatitis B infection can lead to liver failure, hepatocellular carcinoma, and death...
  95. ncbi Preimplantation genetic testing
    Francois Audibert
    The Society of Obstetricians and Gynaecologists of Canada SOGC, Montreal, QC
    J Obstet Gynaecol Can 31:761-75. 2009
    ..To review the techniques and indications of preimplantation genetic testing, including preimplantation genetic diagnosis and screening...
  96. ncbi A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes
    W S Kingery
    Physical Medicine and Rehabilitation Service, Veterans Affairs Palo Alto Health Care System, CA 94304, USA
    Pain 73:123-39. 1997
    ..There was almost no overlap in the controlled trial literature between treatments for PNP and CRPS, and treatments used in both conditions (intravenous phentolamine and epidural clonidine) had similar results...
  97. ncbi Recurrent urinary tract infection
    Annette Epp
    Saskatoon SK
    J Obstet Gynaecol Can 32:1082-90. 2010
    ..Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date restrictions...
  98. ncbi Healing and relapse rates in gastroesophageal reflux disease treated with the newer proton-pump inhibitors lansoprazole, rabeprazole, and pantoprazole compared with omeprazole, ranitidine, and placebo: evidence from randomized clinical trials
    J J Caro
    Division of General Internal Medicine, McGill University, Montreal, Quebec, Canada
    Clin Ther 23:998-1017. 2001
    ..The older proton pump inhibitor (PPI) omeprazole and the newer PPIs lansoprazole, rabeprazole, and pantoprazole are approved for the acute and maintenance treatment of gastroesophageal reflux disease (GERD)...
  99. ncbi Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: An open-label, prospective, nonrandomized, observational study
    Carmen Turbi
    Department of Medical Research, Lilly S A, Madrid, Spain
    Clin Ther 26:245-56. 2004
    ..Low patient compliance with prescribed osteoporosis treatments can severely distort the validity of controlled clinical trials. Raloxifene and alendronate have been shown to reduce the incidence of osteoporotic fracture in ..
  100. pmc Safety and efficacy of acupuncture in children: a review of the evidence
    Vanita Jindal
    Division of Intramural Research, National Center for Complementary Medicine, National Institutes of Health, DHHS, Bethesda, MD, USA
    J Pediatr Hematol Oncol 30:431-42. 2008
    ..We reviewed 31 different published journal articles, including 23 randomized controlled clinical trials and 8 meta-analysis/systematic reviews...
  101. ncbi Management of worsening multiple sclerosis with mitoxantrone: a review
    Edward J Fox
    Multiple Sclerosis Clinic of Central Texas, Round Rock 78681, USA
    Clin Ther 28:461-74. 2006
    ....

Research Grants72

  1. A Systems Biology Approach for Pediatric and Adult Autoimmune Diseases
    MARIA VIRGINIA PASCUAL; Fiscal Year: 2013
    ..To this end, two Phase II randomized, double-blind, placebo-phase controlled clinical trials are proposed...
  2. Multi-center Controlled Clinical Trials in Alport Syndrome-A Feasibility Study
    Clifford E Kashtan; Fiscal Year: 2013
    ..We hope that the approaches we develop will be of relevance to investigators studying other unusual genetic renal disorders. ..
  3. Preclinical Development of a Novel and Effective Treatment for Cough
    Blake M Paterson; Fiscal Year: 2011
    ..antitussive therapy, dextromethorphan (DXM) and codeine, are no better than placebo in the majority of controlled clinical trials and have high abuse liability...
  4. Telehealth Outreach for Chronic Back Pain
    Joseph H Atkinson; Fiscal Year: 2012
    ..Rigorously controlled clinical trials of the type proposed could contribute to more effective, accessible, integrated back pain treatment...
  5. CANCER AND LEUKEMIA GROUP B
    Monica M Bertagnolli; Fiscal Year: 2013
    ..treatment and better understanding of tumor biology and cancer treatment outcomes via the conduct of controlled clinical trials. Over 4,000 members of the Group including oncology physicians, radiologists, pathologists, ..
  6. CANCER AND LEUKEMIA GROUP B CCOP RESEARCH BASE
    Electra D Paskett; Fiscal Year: 2013
    ..treatment and better understanding of tumor biology and cancer treatment outcomes via the conduct of controlled clinical trials. Over 4,000 members of the Group including oncology physicians, radiologists, pathologists, ..
  7. Maternal Opioid Treatment: Human Experimental Research
    Susan Stine; Fiscal Year: 2009
    ..group trained in addiction medicine, psychiatry, pediatrics, obstetrics, neonatology, and controlled clinical trials with the professional expertise to provide comprehensive care for the subjects and rigorous scientific ..
  8. Phase II Therapeutic Trial of Mexiletine
    Richard J Barohn; Fiscal Year: 2010
    ..Because of the rarity of NDM, randomized double-blind placebo controlled clinical trials were not feasible in the past...
  9. Phase I Study in Patients Supporting IV TPM for Neonatal Seizures (9/07, IND7899)
    James Cloyd; Fiscal Year: 2009
    ..The current drugs of choice, phenobarbital and phenytoin, have never been subjected to adequately controlled clinical trials. In uncontrolled studies, fewer than 50% of babies respond to therapy and both drugs are associated with ..
  10. Antitumor and chemopreventive activity of the Ecuadorian plant extract BIRM
    Bal L Lokeshwar; Fiscal Year: 2010
    ..in transgenic models of prostate cancer with the goal of establishing its safety and efficacy for use in controlled clinical trials. In Aim 1, the minimum effective dose, optimum effective dose and maximum tolerated dose of BIRM will be ..
  11. Comparative Effectiveness and Cost Effectiveness of Cancer Chemotherapy
    Xianglin Du; Fiscal Year: 2013
    ..Randomized controlled clinical trials are considered to be the gold standard for determining the efficacy of a therapy...
  12. Testerone Trial
    Peter J Snyder; Fiscal Year: 2013
    ..We therefore propose a closely coordinated set of four, randomized, placebo-controlled clinical trials to test the hypotheses that testosterone treatment for one year of men >65 years who have ..
  13. Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk
    Gregory A Hand; Fiscal Year: 2011
    ..Laboratory-based, tightly controlled clinical trials from our research group and others indicate that physical activity is an appropriate intervention for ..
  14. EXPERIMENTAL THERAPEUTICS IN NEUROLOGICAL DISEASE
    Robert C Griggs; Fiscal Year: 2013
    ..2) the conceptualization, ethics, design, implementation, management, analysis and reporting of controlled clinical trials;and (3) population-based clinical research, including biostatistics and epidemiology...
  15. Evaluation of a Novel Anti-Resorptive Therapy for Osteogenesis Imperfecta
    PATRICIA A COLLIN-OSDOBY; Fiscal Year: 2012
    ..agent for the treatment and management of OI whose therapeutic benefits would merit the initiation of controlled clinical trials with human OI patients...
  16. Soft Tissue Compression Risk in Rotator Cuff Disease Development
    PAULA MARIE LUDEWIG; Fiscal Year: 2013
    ..Subsequent investigations will further test exercise interventions derived from these data through randomized controlled clinical trials comparing to the current standard of care.
  17. Analysis of five year follow-up data from the Weight Loss Maintenance Trial
    Victor J Stevens; Fiscal Year: 2010
    ..however, weight loss must be sustained long-term (defined by NHLBI as at least 5 years), and only a few controlled clinical trials have systematically compared weight loss maintenance strategies for more than one year...
  18. Evolution of Learned Nonuse in Stroke Hemiparesis
    VICTOR WILLIAM MARK; Fiscal Year: 2012
    ..from basic neuroscience research studies and its demonstrated efficacy in numerous randomized controlled clinical trials. The therapy's principal value is for improving the spontaneous use of the paretic upper extremity ..
  19. Clinical Research on Nonalcoholic Fatty Liver Disease
    JOEL EDWARD LAVINE; Fiscal Year: 2013
    ..The NASH CRN currently is conducting 2 multi-center, double-blind, randomized, placebo-controlled clinical trials which require completion in the renewal period, one In children 8-17 years inclusive and the other in ..
  20. Safety and Efficacy of Single-use Cliradex Pads for Ocular Mites
    Scheffer C G Tseng; Fiscal Year: 2012
    ..In this Phase II application, we propose to conduct randomized, double-blind, controlled clinical trials to demonstrate the safety and efficacy of the single-use Cliradex(R) Pad compared to the Placebo Pad for ..
  21. Subclinical thyroid dysfunction in the elderly
    Anne R Cappola; Fiscal Year: 2013
    ..subclinical thyroid dysfunction and to refine the target population and overall design of randomized, controlled clinical trials of therapy for subclinical thyroid dysfunction...
  22. Management of Cancer-Treatment-Induced Bone Loss
    LUKE JOSEPH PEPPONE; Fiscal Year: 2013
    ..of CTIBL, 2) to gain experience as a PI in the design, conduct, and analysis of Phase II/III randomized controlled clinical trials, and 3) to gain experience in the testing and implementation of a nutritional supplement intervention (..
  23. Brain Markers of Anxiety Disorders and SSRI Treatment in Children and Adolescents
    Kinh Luan Phan; Fiscal Year: 2013
    ..first-line treatment with a variable response rate (pooled estimate of 63%;range: 55-91%) based on controlled clinical trials, this study will perform pre- and post-treatment functional MRI (fMRI) of amygdala and amygdala-vPFC ..
  24. Effectiveness of Early Stage Prostate Cancer Treatment
    MARTIN G contact SANDA; Fiscal Year: 2010
    ..and specific Topic 05-CA-104* Comparative Effectiveness Research on Cancer Treatment: "The results of controlled clinical trials guide recommendations for many initial cancer treatments...
  25. Cooperative Lifestyle Intervention Programs (CLIP-II)
    WALTER JOHN REJESKI; Fiscal Year: 2013
    ..the American Society for Nutrition and the Obesity Society highlighted the need for long-term randomized controlled clinical trials evaluating the independent and additive effects of diet-induced weight loss (WL) and exercise in older ..
  26. Rift Valley Fever Vaccine Development of Animal Models and Optimize Production
    Clarence J Peters; Fiscal Year: 2010
    ..animal surrogate model necessary to support efficacy tests under the FDA Animal Rule for diseases where controlled clinical trials are difficult, and to demonstrate protective efficacy in a non-human primate of human antibody to MP-12 ..
  27. CyberTherapy 2009 - 2013
    Brenda K Wiederhold; Fiscal Year: 2013
    ..CT highlights the largest program assembled on controlled clinical trials of virtual reality (VR) and advanced interactive technologies in the areas of mental health, ..
  28. Clinical &metabolic effects of altering n-3 &n-6 fatty acids in migraine (RCT)
    John Douglas Mann; Fiscal Year: 2013
    ..b>Controlled clinical trials investigating pain modulation in response to dietary changes while exploring relevant mechanisms of ..
  29. Plasma and Intrapulmonary Pharmacokinetics and Pharmacodynamics (PKPD) of Aerosol
    Jeffrey Golden; Fiscal Year: 2010
    ..However, treatment strategies and outcomes will have to be determined in future controlled clinical trials. Methods will include administering aerosolized INH, RIF or SM to human subjects and collecting samples ..
  30. EFFICACY OF ANTIDEPRESSANTS IN CHRONIC BACK PAIN
    Joseph H Atkinson; Fiscal Year: 2013
    ..Rigorously controlled clinical trials of the type we propose could contribute to safer, more cost-efficient, and more effective back pain ..
  31. Influence of Exercise and Adiposity on Biomarkers of Breast Cancer Recurrence
    Lisa J Wood; Fiscal Year: 2013
    ..In the absence of controlled clinical trials with survival as an endpoint, exercise studies that provide data on biomarkers of cancer progression can ..
  32. Donepezil to promote functional recovery post-stroke
    Ellen M Whyte; Fiscal Year: 2013
    ..aims of this proposed study are in line with the NCMRR's research priorities, namely "[to] conduct controlled clinical trials to establish&efficacy of treatments to reduce impairments, functional limitations, and disabilities" ..
  33. Computerized Assessment by Remote Examiner System (CARES)
    JAMES P O'HALLORAN; Fiscal Year: 2011
    ..immediate commercial application across a range of healthcare delivery networks, research settings, and controlled clinical trials. PUBLIC HEALTH RELEVANCE: The Computerized Assessment by Remote Examiner System (CARES) is a unique and ..
  34. Computerized Early Dementia Assessment System
    JAMES P O apos HALLORAN; Fiscal Year: 2010
    ..accepted and applied cognitive tests, sufficient to meet the requirements of a minimum of 75 percent of controlled clinical trials as well as related research...
  35. Predictors of CBT Outcomes in Youth Anxiety: Integrative Data Analysis Approach
    Laura C Skriner; Fiscal Year: 2013
    ..The successful treatment of youth anxiety is thus a top health research priority. Results from controlled clinical trials and meta-analyses suggest that, for many youth with an anxiety disorder, cognitive-behavioral therapy (..
  36. Amitriptyline and Topiramate in the Prevention of Childhood Migraine
    Scott W Powers; Fiscal Year: 2013
    ..The central problem is the lack of placebo-controlled clinical trials and comparative effectiveness studies of prophylactic medication therapy...
  37. Amitriptyline and Topiramate in the Prevention of Childhood Migraine: DCC
    Christopher S Coffey; Fiscal Year: 2013
    ..The central problem is the lack of placebo-controlled clinical trials and comparative effectiveness studies of prophylactic medication therapy...
  38. Optimizing Pain Treatment while Reducing Abuse Liability in Opioid Dependence
    David Andrew Tompkins; Fiscal Year: 2013
    ..and the results can be used in preparation of an R01 to (1) extend the work to larger Phase 2/3 controlled clinical trials of acute pain treatment, and/or (2) clinical trials to explore additiona analgesic medications or ..
  39. Overcoming Tramadol Resistance In CYP2D6 Poor Metabolizers
    John A Zebala; Fiscal Year: 2013
    ..Several well controlled clinical trials have shown that the analgesic effect of tramadol is decreased or absent in PM subjects who have low ..
  40. Neuroendocrine Mechanisms of Developmental Massage Therapy in Preterm Infants
    Laurie Moyer Mileur; Fiscal Year: 2009
    ..Well-designed, randomized controlled clinical trials to evaluate the physiological and neuroendocrine mechanisms of massage therapy in premature infants are ..
  41. Implementation of Asthma Guidelines in Primary Care; Comparison of 4 approaches
    James W Mold; Fiscal Year: 2010
    ..1 Randomized controlled clinical trials have demonstrated that implementation of asthma guideline recommendations can significantly improve ..
  42. Facilitating self-regulation of cocaine craving with real-time fMRI feedback
    Melanie Canterberry; Fiscal Year: 2013
    ..of an innovative, individualized approach to the treatment of cocaine dependence and pave the way for controlled clinical trials. Importantly, the proposed research addresses NIDA's strategic goal aimed at developing effective ..
  43. Spanish and English Multimedia Interventon to Increase Organ and Tissue Donation
    Stephen P Wall; Fiscal Year: 2010
    ..The proposed research is a series of randomized controlled clinical trials designed to determine if a Spanish and English multimedia module is superior to a standard brochure used ..
  44. Statistical Methods and Software for Meta-analysis of Diagnostic Tests
    Haitao Chu; Fiscal Year: 2012
    ..statistical challenges compared to traditional meta-analysis applications such as meta-analysis of controlled clinical trials. In particular, diagnostic accuracy cannot be adequately summarized by one measure;two measures are ..
  45. Xylitol syrup for the prevention of acute otitis media in otitis-prone children
    Louis Vernacchio; Fiscal Year: 2010
    ..In two well-designed, randomized, placebo-controlled clinical trials conducted by a single research team in Finland, daily treatment with xylitol five times daily for two to ..
  46. N-Acetylcysteine for Neuroprotection in Parkinson's Disease
    Dikoma C Shungu; Fiscal Year: 2012
    ..of whether there is a GSH deficit in living PD brain that dietary NAC supplementation can mitigate, thereby providing a compelling justification for investigating such neuroprotective strategies in larger controlled clinical trials.
  47. Diffusion Tensor Imaging in First-Episode Schizophrenia
    Philip R Szeszko; Fiscal Year: 2010
    ..to antipsychotic nonresponse in schizophrenia, but research in this area has been limited by the lack of controlled clinical trials from which to recruit patients and test hypotheses...
  48. 1/3-Multisite RCT of Early Intervention for Spoken Communication in Autism
    CONNIE L KASARI; Fiscal Year: 2013
    ..this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis ..
  49. Menopause Symptom Clusters: Refocusing Therapeutics
    Nancy Fugate Woods; Fiscal Year: 2011
    ..symptom clusters, and outcomes of well-being and symptom interference;4) conduct a systematic review of controlled clinical trials to identify symptoms as secondary treatment effects and adverse effects that will inform us about ..
  50. 2/3-Multisite RCT of Early Intervention for Spoken Communication in Autism
    TRISTRAM H SMITH; Fiscal Year: 2013
    ..this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis ..
  51. Excellence In Training: The Center for Anxiety and Related Disorders at BU
    Michael W Otto; Fiscal Year: 2012
    ..Behavioral Treatment, faculty at CARD have notable experience in the conduct of well controlled clinical trials that have helped establish evidence-based practice in behavioral interventions, dissemination efforts, ..
  52. Using Clinically-Enhanced Claims Data to Guide Treatment of Acute Heart Failure
    Mark Sonneborn; Fiscal Year: 2010
    ..databases to provide important information about comparative effectiveness in areas where randomized controlled clinical trials and prospectively designed clinical registries often fall short...
  53. Multicenter Investigation of the Mechanical Determinants of Post-Traumatic OA
    J Lawrence Marsh; Fiscal Year: 2013
    ..These studies offer hope for a paradigm shift in the acute management of articular joint injury, but controlled clinical trials are desperately needed to realize this potential...
  54. Alzheimer's Disease Cooperative Study
    Paul S Aisen; Fiscal Year: 2013
    ..For the coming grant cycle, the ADCS will continue its efforts to advance therapeutics through controlled clinical trials, development o novel instruments and trial designs, recruitment efforts (with particular attention to ..
  55. EFFICACY AND SAFETY OF NARCOTICS FOR PEDIATRIC SEDATION
    Paul Moore; Fiscal Year: 1990
    ..and Sedation in the Dental Office" recognized the liabilities of pediatric sedation and the paucity of controlled clinical trials evaluating sedation treatment modalities...
  56. Intervention effects of intensity and delivery style for toddlers with ASD
    Sally J Rogers; Fiscal Year: 2013
    ..early intervention is a powerful treatment for ASD, improving IQ and language markedly in randomized controlled clinical trials (RCTs), though little long term follow-up data exists...
  57. Building Infrastruture for Comparative Effectiveness Protocols (BICEP)
    JOHN THOMAS LYNCH; Fiscal Year: 2010
    ..PUBLIC HEALTH RELEVANCE: Medical treatments for disease are generally proven through controlled clinical trials with restrictive eligibility criteria-...
  58. POLYUNSATURATES AND KC1 TO CONTROL MILD HYPERTENSION
    Frank Sacks; Fiscal Year: 1991
    Three randomized placebo-controlled clinical trials in mild hypertensives are proposed to assess the hypotensive potential of dietary polyunsaturated fatty acids in fish, oil, and of dietary magnesium, alone and with supplemental ..
  59. META ANALYSIS OF CLINICAL INFORMATION SERVICE TRIALS
    E Balas; Fiscal Year: 2001
    ..of computer- assisted and conventional information services by synthesizing evidence from randomized controlled clinical trials. A series of meta-analyses is proposed to evaluate the effect of major information interventions on the ..
  60. A Video DVD Program to Assist with Informed Consent
    Neil Love; Fiscal Year: 2004
    Randomized controlled clinical trials are universally viewed as the gold standard for evidence-based medicine and the most powerful tool available to evaluate interventions for possible incorporation into clinical practice...
  61. Interstitial Cystitis Clinical Research Network
    Christopher Payne; Fiscal Year: 2007
    ..fully as a member of the steering committee in designing and carrying out multicenter randomized controlled clinical trials (RCTs)...
  62. EVALUATION OF MINIMALLY INVASIVE SURGERY
    Stanley Rogers; Fiscal Year: 2003
    ..The treatment of these common gastrointestinal disorders needs to be studied in randomized controlled clinical trials. Given my training and experience in surgical endoscopy and minimally invasive surgery (laparoscopy), I ..
  63. U.S. India Collaborative Partnership in Parkinson Disease (CPPD)
    KARL D KIEBURTZ; Fiscal Year: 2013
    ..PRAI), each of which is committed to cooperative planning, implementation, analysis and reporting of controlled clinical trials in Parkinson Disease (PD)...
  64. STUDIES ON ENDOTHELIAL DYSFUNCTION IN HEART FAILURE
    Stuart Katz; Fiscal Year: 2004
    ..We now propose: 1) to perform controlled clinical trials to determine whether specific therapies which decrease oxidative stress (Vitamin C, Vitamin E), increase ..
  65. TIDAL LAVAGE VS SHAM LAVAGE IN KNEE OSTEOARTHRITIS
    John Bradley; Fiscal Year: 1999
    DESCRIPTION: (Adapted from Investigator's Abstract) While numerous randomized controlled clinical trials document the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) in the symptomatic management of patients with OA, the utility ..
  66. THROMBOLYSIS IN MYOCARDIAL ISCHEMIA COORDINATING CENTER
    Genell Knatterud; Fiscal Year: 1992
    The Thrombolysis in Myocardial Ischemia (TIMI III) studies consist of two multicenter, randomized controlled clinical trials in patients with unstable angina or non-Q-wave myocardial infarction...
  67. Improving Anti-Thrombotic Use in Stroke Prevention
    Rebecca Beyth; Fiscal Year: 2006
    ..Evidence from controlled clinical trials shows that adjusted-dose warfarin decreases the risk of stroke by two-thirds...
  68. PHYSIOLOGICAL ADAPTATION TO SUSTAINED HYPO-OSMOLALITY
    Joseph Verbalis; Fiscal Year: 2002
    ..Because controlled clinical trials are difficult and potentially dangerous in this population, studies using an animal model that mimics ..
  69. Allicin bioavailability of garlic products
    Larry Lawson; Fiscal Year: 2009
    ..To be able to conduct blinded, placebo-controlled clinical trials, garlic powder supplements have been commonly used...
  70. DCC--INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP
    J Landis; Fiscal Year: 2003
    ..data management and researc computing leadership for the ICCTG in the conduct of a series of randomized, controlled clinical trials (RCTs) at five Clinical Research Centers (CRCs) to investigate current and novel medical therapies for ..
  71. DIET, DISEASE, AND PANCREATIC ENZYME SYNTHESIS IN HUMANS
    STEPHEN O KEEFE; Fiscal Year: 2004
    ..Recent controlled clinical trials suggest that tube-feeding with elemental diets has advantages over TPN with regard to cost, safety (less ..