C Gluud

Summary

Affiliation: Copenhagen Trial Unit
Country: Denmark

Publications

  1. ncbi request reprint [Evidence-based clinical practice]
    Christian Gluud
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, H S Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Zhongguo Yi Xue Ke Xue Yuan Xue Bao 24:541-7. 2002
  2. ncbi request reprint The culture of designing hepato-biliary randomised trials
    Christian Gluud
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Department 7102, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, DK 2100 Copenhagen, Denmark
    J Hepatol 44:607-15. 2006
  3. pmc Clarithromycin for 2 weeks for stable coronary heart disease: 6-year follow-up of the CLARICOR randomized trial and updated meta-analysis of antibiotics for coronary heart disease
    Christian Gluud
    The Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Cardiology 111:280-7. 2008
  4. pmc A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled tria
    Simon Hyttel-Sorensen
    Department of Neonatology, Rigshospitalet, Blegdamsvej 9, Copenhagen DK 2100, Denmark
    Trials 14:120. 2013
  5. pmc The Nordic aortic valve intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial
    Hans Gustav Thyregod
    Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark
    Trials 14:11. 2013
  6. pmc 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial
    Janus Christian Jakobsen
    Psychiatric Research Unit, Copenhagen University Hospital and Region Zealand, Roskilde, Denmark
    BMC Psychiatry 12:232. 2012
  7. pmc Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial
    Jeanett Oestergaard
    Department of Obstetrics and Gynecology, Juliane Marie Centre, Centre for Women, Children and Reproduction, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, Copenhagen 2100, Denmark
    BMC Med Educ 12:7. 2012
  8. pmc Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries
    Christian Gluud
    Copenhagen Trial Unit CTU, Centre for Clinical Intervention Research, and the Danish Clinical Research Infrastructures Network DCRIN, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Trials 13:27. 2012
  9. pmc The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial
    Marianne Melau
    Psychiatric Centre Copenhagen, Copenhagen University, Faculty of Health Sciences, Copenhagen, Denmark
    Trials 12:72. 2011
  10. pmc Cognitive training plus a comprehensive psychosocial programme (OPUS) versus the comprehensive psychosocial programme alone for patients with first-episode schizophrenia (the NEUROCOM trial): a study protocol for a centrally randomised, observer-blinded m
    Lone Vesterager
    Psychiatric Centre Copenhagen, Copenhagen University Hospital, DK 2400, Copenhagen, Denmark
    Trials 12:35. 2011

Detail Information

Publications94

  1. ncbi request reprint [Evidence-based clinical practice]
    Christian Gluud
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, H S Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Zhongguo Yi Xue Ke Xue Yuan Xue Bao 24:541-7. 2002
    ..By investments in education, applied research, and The Cochrane Collaboration, evidence-based medicine may form a stronger basis for clinical practice...
  2. ncbi request reprint The culture of designing hepato-biliary randomised trials
    Christian Gluud
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Department 7102, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, DK 2100 Copenhagen, Denmark
    J Hepatol 44:607-15. 2006
  3. pmc Clarithromycin for 2 weeks for stable coronary heart disease: 6-year follow-up of the CLARICOR randomized trial and updated meta-analysis of antibiotics for coronary heart disease
    Christian Gluud
    The Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Cardiology 111:280-7. 2008
    ..Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses...
  4. pmc A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled tria
    Simon Hyttel-Sorensen
    Department of Neonatology, Rigshospitalet, Blegdamsvej 9, Copenhagen DK 2100, Denmark
    Trials 14:120. 2013
    ....
  5. pmc The Nordic aortic valve intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial
    Hans Gustav Thyregod
    Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark
    Trials 14:11. 2013
    ..Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting...
  6. pmc 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial
    Janus Christian Jakobsen
    Psychiatric Research Unit, Copenhagen University Hospital and Region Zealand, Roskilde, Denmark
    BMC Psychiatry 12:232. 2012
    ..No randomised trial has compared the effects of these two interventions for patients with major depression...
  7. pmc Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial
    Jeanett Oestergaard
    Department of Obstetrics and Gynecology, Juliane Marie Centre, Centre for Women, Children and Reproduction, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, Copenhagen 2100, Denmark
    BMC Med Educ 12:7. 2012
    ..The purpose of this trial is to investigate the impact of instructor feedback regarding time, repetitions and self-perception when training complex operational tasks on a virtual reality simulator...
  8. pmc Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries
    Christian Gluud
    Copenhagen Trial Unit CTU, Centre for Clinical Intervention Research, and the Danish Clinical Research Infrastructures Network DCRIN, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Trials 13:27. 2012
    ..In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe...
  9. pmc The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial
    Marianne Melau
    Psychiatric Centre Copenhagen, Copenhagen University, Faculty of Health Sciences, Copenhagen, Denmark
    Trials 12:72. 2011
    ..The major objective of the OPUS II trial is to evaluate the effects of five years of OPUS treatment versus two years of OPUS treatment...
  10. pmc Cognitive training plus a comprehensive psychosocial programme (OPUS) versus the comprehensive psychosocial programme alone for patients with first-episode schizophrenia (the NEUROCOM trial): a study protocol for a centrally randomised, observer-blinded m
    Lone Vesterager
    Psychiatric Centre Copenhagen, Copenhagen University Hospital, DK 2400, Copenhagen, Denmark
    Trials 12:35. 2011
    ..It is hypothesized that addition of cognitive training to a comprehensive psychosocial programme (OPUS) enhances both cognitive and everyday functional capacity of patients more than the comprehensive psychosocial programme alone...
  11. pmc Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol
    Ole Jakob Storebø
    Child Psychiatric Daytime Clinic, Child and Adolescent Psychiatric Centre, Region Zealand, Holbaek, Denmark
    Trials 12:18. 2011
    ..Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions...
  12. pmc The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders--design of two randomised c
    Lars Vedel Kessing
    Mood Disorder Clinic, Psychiatric Centre Copenhagen, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Trials 12:32. 2011
    ..It is not known whether centralised and specialised secondary care intervention initiated early after the onset of the diseases can prevent the progression and thereby improve the prognosis...
  13. pmc Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)
    Christine Kubiak
    Institut Thématique Santé Publique, Institut National de la Sante et de la Recherche Medicale INSERM, Paris, France
    Trials 10:95. 2009
    ..Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states...
  14. pmc Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus
    Ulla Knorr
    Department of Psychiatry, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Trials 10:66. 2009
    ..The primary outcome measure is the change in plasma cortisol in the dexamethasone-corticotrophin releasing hormone test from baseline to the end of intervention...
  15. pmc Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries
    Kate Whitfield
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital DCRIN, Copenhagen, DK 2100, Denmark
    Trials 11:104. 2010
    ..We sought to understand how such programmes are regulated in ten European Union countries...
  16. pmc Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol
    Lone Baandrup
    Center for Neuropsychiatric Schizophrenia Research CNSR and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research CINS, University of Copenhagen, Mental Health Centre Glostrup, Mental Health Services Capital Region of Denmark, Glostrup, Denmark
    BMC Psychiatry 11:160. 2011
    ..Furthermore, we aim to investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life...
  17. pmc Estimating required information size by quantifying diversity in random-effects model meta-analyses
    Jørn Wetterslev
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100 Copenhagen Ø, Denmark
    BMC Med Res Methodol 9:86. 2009
    ..The required information size in a meta-analysis may be calculated from an anticipated a priori intervention effect or from an intervention effect suggested by trials with low-risk of bias...
  18. pmc Evidence at a glance: error matrix approach for overviewing available evidence
    Frederik Keus
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    BMC Med Res Methodol 10:90. 2010
    ..We aimed at conceptualizing a visual assessment tool, i.e., a matrix for overviewing studies and their data in order to assess the clinical evidence at a glance...
  19. pmc The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema
    Kristina Sophie Ibler
    Department of Dermatology, Roskilde Hospital, Roskilde, Denmark
    BMC Dermatol 10:8. 2010
    ..32 per 1000 person-years. Consequences of hand eczema include chronic severe eczema, prolonged sick leave, unemployment, and impaired quality of life. New preventive strategies are needed to reduce occupational hand eczema...
  20. pmc Mortality from cirrhosis: lack of progress over the last 35 years
    C Gluud
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7102, Rigshospitalet, Copenhagen University Hospital, DK 2100 Copenhagen, Denmark
    Gut 54:1523-6. 2005
  21. ncbi request reprint Hepatology may have problems with putative surrogate outcome measures
    Christian Gluud
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, DK 2100 Copenhagen, Denmark
    J Hepatol 46:734-42. 2007
    ..The challenge is to develop reliable surrogates, both to facilitate the development of new interventions and to ensure our patients and us that these interventions are effective clinically...
  22. ncbi request reprint [The GCP directive--consequences for clinical drug research]
    Christian N Gluud
    Copenhagen Trial Unit, Center for Klinisk Interventionsforskning, Afsnit 7102, H S Rigshospitalet, Blegdamsvej 9, DK 2100 København Ø
    Ugeskr Laeger 165:1662-4. 2003
    ..Patients will be assured the same quality in trials irrespective of the industry or investigator being the sponsor and may look forward to quality improvement of drug trials...
  23. pmc Evidence based diagnostics
    Christian Gluud
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, H S Rigshospitalet, Copenhagen University Hospital, DK 2100 Copenhagen, Denmark
    BMJ 330:724-6. 2005
  24. doi request reprint Meta-analysis: antioxidant supplements for liver diseases - the Cochrane Hepato-Biliary Group
    G Bjelakovic
    Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark
    Aliment Pharmacol Ther 32:356-67. 2010
    ..Several liver diseases have been associated with oxidative stress. Accordingly, antioxidants have been suggested as potential therapeutics for various liver diseases. The evidence supporting these suggestions is equivocal...
  25. ncbi request reprint Funding, disease area, and internal validity of hepatobiliary randomized clinical trials
    Lise Lotte Kjaergard
    The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark
    Am J Gastroenterol 97:2708-13. 2002
    ..The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials...
  26. ncbi request reprint The journal impact factor as a predictor of trial quality and outcomes: cohort study of hepatobiliary randomized clinical trials
    Lise L Gluud
    The Cochrane Hepato Biliary Group, The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen, Denmark
    Am J Gastroenterol 100:2431-5. 2005
    ..To examine the association between the impact factor and characteristics of hepatobiliary randomized clinical trials...
  27. pmc Interferon alfa with or without ribavirin for chronic hepatitis C: systematic review of randomised trials
    L L Kjaergard
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Research, Rigshospitalet, DK 2100, Copenhagen, Denmark
    BMJ 323:1151-5. 2001
    ..To assess the efficacy and safety of interferon alfa with or without ribavirin for treatment of chronic hepatitis C...
  28. ncbi request reprint Meta-analysis: ribavirin plus interferon vs. interferon monotherapy for chronic hepatitic C - an updated Cochrane review
    J Brok
    Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark
    Aliment Pharmacol Ther 32:840-50. 2010
    ..Multiple randomized trials have been published on antiviral treatment for chronic hepatitis C...
  29. ncbi request reprint Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C
    M Simin
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Aliment Pharmacol Ther 25:1153-62. 2007
    ..About 170 million patients worldwide have chronic hepatitis C. Pegylated interferon plus ribavirin is currently the recommended therapy...
  30. ncbi request reprint The Best Bypass Surgery Trial: rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting
    Christian H Møller
    Department of Cardiothoracic Surgery, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Contemp Clin Trials 28:540-7. 2007
    ..Patients with a moderate- to high-risk of complications after CCAB may have additional benefit from OPCAB...
  31. pmc ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial
    Gudrun Boysen
    Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg Bakke 23, DK 2400 Copenhagen NV, Denmark
    BMJ 339:b2810. 2009
    ..To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity...
  32. ncbi request reprint Quality assessment of reports on clinical trials in the Journal of Hepatology
    C Gluud
    The Copenhagen Trial Unit, Institute of Preventive Medicine, Copenhagen University Hospital, Denmark
    J Hepatol 29:321-7. 1998
    ..The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qualitative assessment of the reporting...
  33. ncbi request reprint Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses
    L L Kjaergard
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, H S Rigshospitalet, DK 2100 Copenhagen, Denmark
    Ann Intern Med 135:982-9. 2001
    ..To explore whether reported methodologic quality affects estimated intervention effects in randomized trials and contributes to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses...
  34. doi request reprint Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: systematic review of randomized trials
    Tahany Awad
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Hepatology 51:1176-84. 2010
    ..However, the paucity of evidence on adverse events curbs the decision to definitively recommend one peginterferon over the other, because any potential benefit must outweigh the risk of harm...
  35. ncbi request reprint Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis
    Jørn Wetterslev
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark
    J Clin Epidemiol 61:64-75. 2008
    ..Trial sequential analysis (TSA) corresponds to group sequential analysis of a single trial and may be applied to meta-analysis to evaluate the evidence...
  36. doi request reprint Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses
    Jesper Brok
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Cochrane Hepato Biliary Group, Dept 3344, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100 Copenhagen, Denmark
    J Clin Epidemiol 61:763-9. 2008
    ..Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries analogous to interim monitoring boundaries in a single trial...
  37. doi request reprint Clinical outcomes in randomized trials of off- vs. on-pump coronary artery bypass surgery: systematic review with meta-analyses and trial sequential analyses
    Christian H Møller
    Department of Cardio Thoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Eur Heart J 29:2601-16. 2008
    ..To assess the clinical outcomes of off- vs. on-pump coronary artery bypass surgery in randomized trials...
  38. doi request reprint Interleukin-2 receptor antagonists as induction therapy after heart transplantation: systematic review with meta-analysis of randomized trials
    Christian H Møller
    Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    J Heart Lung Transplant 27:835-42. 2008
    ..Interleukin-2 receptor antagonists (IL-2Ras) are used increasingly for induction therapy. We conducted a systematic review of randomized trials assessing IL-2Ras...
  39. doi request reprint Graft patency after off-pump versus on-pump coronary artery surgery in high-risk patients
    Christian H Møller
    Department of Cardio Thoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Denmark
    Scand Cardiovasc J 44:161-7. 2010
    ..To compare angiographic graft patency in high-risk patients randomly allocated to off-pump vs. on-pump coronary artery bypass grafting (CABG)...
  40. doi request reprint Hepato-biliary clinical trials and their inclusion in the Cochrane Hepato-Biliary Group register and reviews
    Sarah Louise Klingenberg
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    J Gastroenterol Hepatol 26:649-56. 2011
    ..In this overview, we present the growth of The CHBG Controlled Trials Register, as well as the systematic reviews that have been produced since March 1996...
  41. doi request reprint Tacrolimus versus cyclosporine as primary immunosuppression after heart transplantation: systematic review with meta-analyses and trial sequential analyses of randomised trials
    Luit Penninga
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Cochrane Hepato Biliary Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Eur J Clin Pharmacol 66:1177-87. 2010
    ..We conducted a systematic review of randomized trials to compare the benefits and harms of tacrolimus versus cyclosporine as primary immunosuppression after heart transplantation...
  42. ncbi request reprint [Reporting adverse reactions and events in randomised clinical trials]
    Bianca Hemmingsen
    Copenhagen Trial Unit, Center for Klinisk Interventionsforskning, Rigshospitalet, 2100 København Ø, Denmark
    Ugeskr Laeger 172:2381-4. 2010
    ....
  43. doi request reprint No major differences in 30-day outcomes in high-risk patients randomized to off-pump versus on-pump coronary bypass surgery: the best bypass surgery trial
    Christian H Møller
    Cardiothoracic Surgery, Department 2152, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark
    Circulation 121:498-504. 2010
    ..Our objective was to compare 30-day outcomes in high-risk patients randomized to coronary artery bypass grafting without or with cardiopulmonary bypass...
  44. doi request reprint Apparently conclusive meta-analyses may be inconclusive--Trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses
    Jesper Brok
    The Copenhagen Trial Unit, Center for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Int J Epidemiol 38:287-98. 2009
    ..This is analogous to sequential monitoring boundaries in a single trial...
  45. ncbi request reprint Artificial and bioartificial support systems for acute and acute-on-chronic liver failure: a systematic review
    Lise L Kjaergard
    The Cochrane Hepato Biliary Group, The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H S Rigshospitalet, Blegdamsvej 9, DK 2100, Copenhagen, Denmark
    JAMA 289:217-22. 2003
    ..Artificial and bioartificial support systems may provide a "bridge" for patients with severe liver disease to recovery or transplantation...
  46. pmc Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial
    Anne Benedicte Juul
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, H S Rigshospitalet, Copenhagen University Hospital, Denmark
    BMJ 332:1482. 2006
    ..To evaluate the long term effects of perioperative beta blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery...
  47. ncbi request reprint Citation bias of hepato-biliary randomized clinical trials
    Lise L Kjaergard
    The Cochrane Hepato Biliary Group, The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark
    J Clin Epidemiol 55:407-10. 2002
    ..We concluded that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality...
  48. ncbi request reprint Misuse of randomization: a review of Chinese randomized trials of herbal medicines for chronic hepatitis B
    Jianping Liu
    The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H S Rigshospitalet, Denmark
    Am J Chin Med 30:173-6. 2002
    ..05 level of probability for the two treatments and 13.3% (20/150) imbalanced at the 0.01 level in the randomization. It is suggested that there may exist misunderstanding of the concept and the misuse of randomization based on the review...
  49. ncbi request reprint Artificial and bioartificial support systems for liver failure: a Cochrane Hepato-Biliary Group Protocol
    Jianping Liu
    The Cochrane Hepato Biliary Group, The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H S Rigshospitalet, Blegdamsvej 9, DK 2100, Copenhagen, Denmark
    Liver 22:433-8. 2002
    ..This review is to evaluate the beneficial and harmful effects of artificial and bioartificial support systems for acute and acute-on-chronic liver failure...
  50. ncbi request reprint The Diabetic Postoperative Mortality and Morbidity (DIPOM) trial: rationale and design of a multicenter, randomized, placebo-controlled, clinical trial of metoprolol for patients with diabetes mellitus who are undergoing major noncardiac surgery
    Anne Benedicte Juul
    Copenhagen Trial Unit, Center for Clinical Intervention Research, H S Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Am Heart J 147:677-83. 2004
    ..Patients with diabetes mellitus are at a high-risk for postoperative cardiac morbidity and mortality. They may, therefore, benefit from perioperative beta-blockade...
  51. pmc Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials
    Bodil Als-Nielsen
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Department 7102, H S Rigshospitalet, DK 2100 Copenhagen, Denmark
    BMJ 328:1046. 2004
    ..To assess the effects of non-absorbable disaccharides (lactulose and lactitol) in patients with hepatic encephalopathy...
  52. ncbi request reprint Effects of adding ribavirin to interferon to treat chronic hepatitis C infection: a systematic review and meta-analysis of randomized trials
    Jesper Brok
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Arch Intern Med 165:2206-12. 2005
    ..However, combination therapy is associated with increased risk for adverse events...
  53. ncbi request reprint Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?
    Bodil Als-Nielsen
    The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark
    JAMA 290:921-8. 2003
    ..Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions...
  54. ncbi request reprint Agreement between Cochrane Neonatal Group reviews and clinical guidelines for newborns at a Copenhagen University Hospital - a cross-sectional study
    Jesper Brok
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H S Rigshospitalet, Denmark
    Acta Paediatr 96:39-43. 2007
    ....
  55. doi request reprint Compliance with and short-term adverse events from clarithromycin versus placebo in patients with stable coronary heart disease: the CLARICOR trial
    C M Jespersen
    The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100 Copenhagen, Denmark
    J Antimicrob Chemother 64:411-5. 2009
    ....
  56. ncbi request reprint Colchicine for alcoholic and non-alcoholic liver fibrosis or cirrhosis
    A Rambaldi
    The Cochrane Hepato-Biliary Group, The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H:S Kommunehospitalet, Copenhagen, Denmark
    Liver 21:129-36. 2001
    ..41; CI 2.24, 8.70; p< 0.001). CONCLUSIONS: Colchicine should not be used for liver fibrosis or liver cirrhosis irrespective of etiology. Future trials on colchicine for liver diseases ought to be large...
  57. doi request reprint High serum YKL-40 concentration is associated with cardiovascular and all-cause mortality in patients with stable coronary artery disease
    Jens Kastrup
    Department of Medicine B, Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, Copenhagen University Hospital and Faculty of Health Sciences, Blegdamsvej 9, DK 2100 Copenhagen, Denmark
    Eur Heart J 30:1066-72. 2009
    ..Macrophages in atherosclerotic plaques secrete YKL-40. We tested the hypothesis if high serum YKL-40 concentration predicts coronary events and death of patients with stable coronary artery disease (CAD)...
  58. ncbi request reprint Ribavirin monotherapy for chronic hepatitis C infection: a Cochrane Hepato-Biliary Group systematic review and meta-analysis of randomized trials
    Jesper Brok
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Denmark
    Am J Gastroenterol 101:842-7. 2006
    ..We conducted a systematic review to assess the benefits and harms of ribavirin monotherapy for patients with chronic hepatitis C...
  59. ncbi request reprint Agreement between Cochrane Neonatal reviews and clinical practice guidelines for newborns in Denmark: a cross-sectional study
    J Brok
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen, Denmark
    Arch Dis Child Fetal Neonatal Ed 93:F225-9. 2008
    ..To assess agreement between Cochrane Neonatal Group reviews and clinical practice guidelines in Denmark...
  60. doi request reprint Exercise program for prevention of groin pain in football players: a cluster-randomized trial
    P Holmich
    Department of Orthopaedic Surgery, Orthopaedic Research Centre, Amager Hospital, Copenhagen University Hospital, Copenhagen, Denmark
    Scand J Med Sci Sports 20:814-21. 2010
    ..A univariate analysis showed that having had a previous groin injury almost doubles the risk of developing a new groin injury and playing at a higher level almost triples the risk of developing a groin injury...
  61. doi request reprint Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed
    Frederik Keus
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    J Clin Epidemiol 63:246-56. 2010
    ..Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small-incision cholecystectomy regarding different outcome measures for the occurrence of type I errors...
  62. ncbi request reprint The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines
    Anne Benedicte Juul
    The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
    Int J Health Care Qual Assur Inc Leadersh Health Serv 18:321-8. 2005
    ..To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation...
  63. doi request reprint Chlamydia pneumoniae IgG and IgA antibody titers and prognosis in patients with coronary heart disease: results from the CLARICOR trial
    Jørgen Hilden
    The Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, DK 2100 Copenhagen, Denmark
    Diagn Microbiol Infect Dis 66:385-92. 2010
    ..Smoking-related lung disease probably underlies the link between heart disease and increased IgG titers...
  64. ncbi request reprint Milk thistle for alcoholic and/or hepatitis B or C liver diseases--a systematic cochrane hepato-biliary group review with meta-analyses of randomized clinical trials
    Andrea Rambaldi
    Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark
    Am J Gastroenterol 100:2583-91. 2005
    ..Our objectives were to assess the beneficial and harmful effects of milk thistle (MT) or MT constituents versus placebo or no intervention in patients with alcoholic liver disease and/or hepatitis B and/or C liver diseases...
  65. ncbi request reprint Ursodeoxycholic acid for patients with primary biliary cirrhosis: an updated systematic review and meta-analysis of randomized clinical trials using Bayesian approach as sensitivity analyses
    Yan Gong
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Department 7102, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Am J Gastroenterol 102:1799-807. 2007
    ..Ursodeoxycholic acid (UDCA) is used for primary biliary cirrhosis (PBC), but the beneficial effects remain controversial...
  66. pmc Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial
    Christian M Jespersen
    Bispebjerg Hospital, Copenhagen University Hospital, Department of Cardiology Y, Bispebjerg Bakke 23, DK 2400 Copenhagen, Denmark
    BMJ 332:22-7. 2006
    ..To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease...
  67. doi request reprint Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses?
    Kristian Thorlund
    Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Department 3344, Blegdamsvej 9, DK 2100 Copenhagen, Denmark
    Int J Epidemiol 38:276-86. 2009
    ..e. applying trial sequential monitoring boundaries)...
  68. ncbi request reprint Photodynamic therapy with 5-aminolaevulinic acid or placebo for recalcitrant foot and hand warts: randomised double-blind trial
    I M Stender
    Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark
    Lancet 355:963-6. 2000
    ..Therefore, we undertook a randomised, parallel, double-blind clinical trial of ALA-PDT versus placeboPDT for recalcitrant foot and hand warts...
  69. doi request reprint Prestroke physical activity is associated with severity and long-term outcome from first-ever stroke
    L H Krarup
    Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark
    Neurology 71:1313-8. 2008
    ..To determine whether prestroke level of physical activity influenced stroke severity and long-term outcome...
  70. ncbi request reprint Systematic review: primary and secondary prevention of gastrointestinal cancers with antioxidant supplements
    G Bjelakovic
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigs Hospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Aliment Pharmacol Ther 28:689-703. 2008
    ..The evidence on whether antioxidant supplements prevent gastrointestinal cancers is contradictory...
  71. doi request reprint Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial
    C Lundsgaard
    Department of Geriatrics and Rheumatology, Glostrup Hospital the county of Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark
    Scand J Rheumatol 37:142-50. 2008
    ..We conducted a randomized, patient- and observer-blind trial to evaluate these interventions in patients with painful knee osteoarthritis...
  72. ncbi request reprint Systematic review and meta-analysis: D-Penicillamine vs. placebo/no intervention in patients with primary biliary cirrhosis--Cochrane Hepato-Biliary Group
    Y Gong
    Copenhagen Trial Unit, Centre for Clinical Intervention Research, H S Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Aliment Pharmacol Ther 24:1535-44. 2006
    ..The results on effects of D--penicillamine in randomized-clinical trials of primary biliary cirrhosis patients are inconsistent...
  73. doi request reprint Effect of pamidronate 30 mg versus 90 mg on physical function in patients with newly diagnosed multiple myeloma (Nordic Myeloma Study Group): a double-blind, randomised controlled trial
    Peter Gimsing
    Department of Haematology, Rigshospitalet and Copenhagen University, Copenhagen, Denmark
    Lancet Oncol 11:973-82. 2010
    ..This study compared the effect of two doses of pamidronate on health-related quality of life and skeletal morbidity in patients with newly diagnosed multiple myeloma...
  74. ncbi request reprint Hospital doctors' self-rated skills in and use of evidence-based medicine - a questionnaire survey
    Roberto S Oliveri
    Department of Surgical Gastroenterology K, H S Bispebjerg Hospital, Copenhagen University Hospital, Denmark
    J Eval Clin Pract 10:219-26. 2004
    ..We examined hospital doctors' skills in EBM terms and related these skills to their use of information sources, critical appraisal, and implementation of EBM into clinical practice...
  75. ncbi request reprint Agreement between reported use of interventions for liver diseases and research evidence in Cochrane systematic reviews
    Pia Kürstein
    DSI Danish Institute for Health Services Research, Copenhagen, Denmark
    J Hepatol 43:984-9. 2005
    ..This study evaluates the agreement between reported use of interventions for patients with liver diseases and research evidence in Cochrane systematic reviews...
  76. doi request reprint Hospital-based comprehensive cardiac rehabilitation versus usual care among patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease: 12-month results of a randomized clinical trial
    Ann Dorthe Olsen Zwisler
    Cardiac Rehabilitation Unit, Department of Cardiology, Bispebjerg Hospital, Copenhagen, Denmark
    Am Heart J 155:1106-13. 2008
    ..We investigated the 12-month effect of hospital-based CCR versus usual care (UC) for a broadly defined group of cardiac patients within the modern therapeutic era of cardiology...
  77. ncbi request reprint Colchicine for primary biliary cirrhosis: a Cochrane Hepato-Biliary Group systematic review of randomized clinical trials
    Yan Gong
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, H S Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
    Am J Gastroenterol 100:1876-85. 2005
    ..The results from randomized clinical trials have, however, been inconsistent. We conducted a systematical review to evaluate the effect of colchicine for primary biliary cirrhosis...
  78. ncbi request reprint Validity of randomized clinical trials in gastroenterology from 1964-2000
    Lise L Kjaergard
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
    Gastroenterology 122:1157-60. 2002
    ..We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000...
  79. doi request reprint Statin treatment prevents increased cardiovascular and all-cause mortality associated with clarithromycin in patients with stable coronary heart disease
    Gorm B Jensen
    Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Denmark
    J Cardiovasc Pharmacol 55:123-8. 2010
    ..41). Multivariate analysis and 6-year follow up confirmed these results. Concomitant statin treatment in stable patients with coronary heart disease abrogated the observed increased CV mortality associated with 2 weeks of clarithromycin...
  80. ncbi request reprint The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke
    Lars Henrik Krarup
    Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Denmark
    Contemp Clin Trials 29:410-7. 2008
    ..We describe the rationale, design, and baseline data of the ExStroke Pilot Trial...
  81. ncbi request reprint Meta-analysis: antioxidant supplements for primary and secondary prevention of colorectal adenoma
    G Bjelakovic
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H S Rigshospitalet, Copenhagen, Denmark
    Aliment Pharmacol Ther 24:281-91. 2006
    ..Colorectal cancer may be prevented by reducing the development of adenomatous polyps...
  82. ncbi request reprint A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision
    Magnus S AGren
    Department of Surgery K, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark
    Wound Repair Regen 14:526-35. 2006
    ..Larger clinical trials will be required to show definitive effects of topical zinc oxide on wound healing and infection...
  83. ncbi request reprint Anabolic-androgenic steroids for alcoholic liver disease: a Cochrane review
    Andrea Rambaldi
    The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Denmark
    Am J Gastroenterol 97:1674-81. 2002
    ..The objectives were to assess the beneficial and harmful effects of anabolic-androgenic steroids for alcoholic liver disease...
  84. ncbi request reprint Medicinal herbs for hepatitis C virus infection: a Cochrane hepatobiliary systematic review of randomized trials
    Jianping Liu
    The Cochrane Hepatobiliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark
    Am J Gastroenterol 98:538-44. 2003
    ..The aim of this study was to assess beneficial and harmful effects of medicinal herbs for hepatitis C virus (HCV) infection...
  85. ncbi request reprint Antioxidant supplements for prevention of gastrointestinal cancers: a systematic review and meta-analysis
    Goran Bjelakovic
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H S Rigshospitalet, Copenhagen, Denmark
    Lancet 364:1219-28. 2004
    ..Oxidative stress can cause cancer. Our aim was to establish whether antioxidant supplements reduce the incidence of gastrointestinal cancer and mortality...
  86. ncbi request reprint A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease (the DANREHAB trial)--design, intervention, an
    Ann Dorthe Olsen Zwisler
    Department of Cardiology, H S Bispebjerg Hospital, Copenhagen, Denmark
    Am Heart J 150:899. 2005
    ..Current guidelines broadly recommend comprehensive cardiac rehabilitation (CR), although evidence for this is still limited. It is not known whether evidence from before 1995 is still valid...
  87. pmc Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis
    Chuanfang Lee
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Copenhagen University Hospital, Denmark
    BMJ 332:328-36. 2006
    ..To evaluate the effects of hepatitis B vaccine and immunoglobulin in newborn infants of mothers positive for hepatitis B surface antigen...
  88. ncbi request reprint Banding ligation versus beta-blockers as primary prophylaxis in esophageal varices: systematic review of randomized trials
    Lise L Gluud
    Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen, Denmark
    Am J Gastroenterol 102:2842-8; quiz 2841, 2849. 2007
    ..To compare banding ligation versus beta-blockers as primary prophylaxis in patients with esophageal varices and no previous bleeding...
  89. ncbi request reprint Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis
    Goran Bjelakovic
    The Cochrane Hepato Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
    JAMA 297:842-57. 2007
    ..Antioxidant supplements are used for prevention of several diseases...
  90. ncbi request reprint [Are treatment effects or adverse effects of significance for the association between financing and conclusions in randomized trials?]
    Bodil E Als-Nielsen
    H S Rigshospitalet, Center for Klinisk Interventionsforskning, Copenhagen Trial Unit
    Ugeskr Laeger 166:1676-8. 2004
  91. ncbi request reprint [Nonabsorbable disaccharides for the treatment of hepatic encephalopathy--a systemic review of randomized clinical trials--a secondary publication]
    Bodil E Als-Nielsen
    H S Rigshospitalet, Copenhagen Trial Unit, Center for Klinisk Interventionsforskning
    Ugeskr Laeger 167:179-82. 2005
  92. ncbi request reprint [Evidence-based clinical practice]
    Christian N Gluud
    Ugeskr Laeger 165:1429. 2003
  93. ncbi request reprint [Danish clinical intervention research--can it be done better?]
    Christian N Gluud
    Ugeskr Laeger 167:1003. 2005