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Rigshospitalet - a part of Copenhagen University Hospital

Trials, 1745-6215

Journal

  1. 2019
  2. Published

    Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

    Hansen, M. L., Pellicer, A., Gluud, C., Dempsey, E., Mintzer, J., Hyttel-Sørensen, S., Heuchan, A. M., Hagmann, C., Ergenekon, E., Dimitriou, G., Pichler, G., Naulaers, G., Cheng, G., Guimarães, H., Tkaczyk, J., Kreutzer, K. B., Fumagalli, M., Claris, O., Lemmers, P., Fredly, S., Szczapa, T., Austin, T., Jakobsen, J. C. & Greisen, G., 30 Dec 2019, In : Trials. 20, 1, p. 811

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Published
  4. Published

    Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial)

    Hulsbæk, S., Ban, I., Aasvang, T. K., Jensen, J-E. B., Kehlet, H., Foss, N. B., Bandholm, T. & Kristensen, M. T., 23 Dec 2019, In : Trials. 20, 763.

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Published

    Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants

    Hansen, M. L., Pellicer, A., Gluud, C., Dempsey, E., Mintzer, J., Hyttel-Sorensen, S., Heuchan, A. M., Hagmann, C., Dimitriou, G., Pichler, G., Naulaers, G., Cheng, G., Vilan, A., Tkaczyk, J., Kreutzer, K. B., Fumagalli, M., Claris, O., Fredly, S., Szczapa, T., Lange, T., Jakobsen, J. C. & Greisen, G., 19 Dec 2019, In : Trials. 20, 1, p. 746

    Research output: Contribution to journalJournal articleResearchpeer-review

  6. Published

    Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations

    Dombernowsky, T., Haedersdal, M., Lassen, U. & Thomsen, S. F., 11 Dec 2019, In : Trials. 20, 1, p. 708

    Research output: Contribution to journalJournal articleResearchpeer-review

  7. Published
  8. Published

    Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF)

    Jensen, J., Omar, M., Kistorp, C., Poulsen, M. K., Tuxen, C., Gustafsson, I., Køber, L., Gustafsson, F., Fosbøl, E., Bruun, N. E., Videbæk, L., Frederiksen, P. H., Møller, J. E. & Schou, M., 21 Jun 2019, In : Trials. 20, 1, p. 374 374.

    Research output: Contribution to journalJournal articleResearchpeer-review

  9. Published

    Design paper of the "Blood pressure targets in post-resuscitation care and bedside monitoring of cerebral energy state: a randomized clinical trial"

    Mölström, S., Nielsen, T. H., Nordström, C. H., Hassager, C., Møller, J. E., Kjærgaard, J., Möller, S., Schmidt, H. & Toft, P., 10 Jun 2019, In : Trials. 20, 1, p. 344

    Research output: Contribution to journalJournal articleResearchpeer-review

  10. Published
  11. Published

    MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis

    MESEMS study group, 9 May 2019, In : Trials. 20, 1, p. 263

    Research output: Contribution to journalJournal articleResearchpeer-review

  12. Published

    Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia (SAB7): study protocol for a randomized controlled trial

    Thorlacius-Ussing, L., Andersen, C. Ø., Frimodt-Møller, N., Knudsen, I. J. D., Lundgren, J. & Benfield, T. L., 2 May 2019, In : Trials. 20, 8 p., 250.

    Research output: Contribution to journalJournal articleResearchpeer-review

  13. Published

    Community-based interventions to prevent serious complications following spinal cord injury in Bangladesh: the CIVIC trial statistical analysis plan

    Herbert, R. D., Harvey, L. A., Hossain, M. S., Islam, M. S., Li, Q., Billot, L., CIVIC Trial Collaboration & Biering-Sørensen, F., 25 Apr 2019, In : Trials. 20, 1, p. 238

    Research output: Contribution to journalJournal articleResearchpeer-review

  14. Published

    Correction to: Effect of action-based cognitive remediation on cognition and neural activity in bipolar disorder: study protocol for a randomized controlled trial

    Ott, C. V., Vinberg, M., Bowie, C. R., Christensen, E. M., Knudsen, G. M., Kessing, L. V. & Miskowiak, K. W., 8 Apr 2019, In : Trials. 20, 1, p. 201

    Research output: Contribution to journalJournal articleResearchpeer-review

  15. Published

    Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial

    Juul, S., Lunn, S., Poulsen, S., Sørensen, P., Salimi, M., Jakobsen, J. C., Bateman, A. & Simonsen, S., 5 Apr 2019, In : Trials. 20, 1, p. 196

    Research output: Contribution to journalJournal articleResearchpeer-review

  16. Published

    Detailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restriction

    Pels, A., Jakobsen, J. C., Ganzevoort, W., Naaktgeboren, C. A., Onland, W., van Wassenaer-Leemhuis, A. G. & Gluud, C., 11 Jan 2019, In : Trials. 20, 1, p. 42

    Research output: Contribution to journalJournal articleResearchpeer-review

  17. 2018
  18. Published
  19. Published

    Effects of recombinant human erythropoietin on cognition and neural activity in remitted patients with mood disorders and first-degree relatives of patients with psychiatric disorders: a study protocol for a randomized controlled trial

    Petersen, J. Z., Schmidt, L. S., Vinberg, M., Jørgensen, M. B., Hageman, I., Ehrenreich, H., Knudsen, G. M., Kessing, L. V. & Miskowiak, K. W., 6 Nov 2018, In : Trials. 19, 1, p. 611

    Research output: Contribution to journalJournal articleResearchpeer-review

  20. Published

    Effect of action-based cognitive remediation on cognition and neural activity in bipolar disorder: study protocol for a randomized controlled trial

    Ott, C. V., Vinberg, M., Bowie, C. R., Christensen, E. M., Knudsen, G. M., Kessing, L. V. & Miskowiak, K. W., 12 Sep 2018, In : Trials. 19, 1, p. 487

    Research output: Contribution to journalJournal articleResearchpeer-review

  21. Published
  22. Published

    Erythropoietin as an add-on treatment for cognitive side effects of electroconvulsive therapy: a study protocol for a randomized controlled trial

    Schmidt, L. S., Petersen, J. Z., Vinberg, M., Hageman, I., Olsen, N. V., Kessing, L. V., Jørgensen, M. B. & Miskowiak, K. W., 19 Apr 2018, In : Trials. 19, 1, p. 234

    Research output: Contribution to journalJournal articleResearchpeer-review

  23. Published

    The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial

    Jepsen, D. B., Ryg, J., Jørgensen, N. R., Hansen, S. & Masud, T., 16 Mar 2018, In : Trials. 19, 1, p. 186

    Research output: Contribution to journalJournal articleResearchpeer-review

  24. Published

    Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study

    Schefold, J. C., Perner, A., Lange, T., Wetterslev, J., Wise, M. P., Borthwick, M., Bendel, S., Keus, F., Guttormsen, A. B., Marker, S., Krag, M., Møller, M. H. & SUP-ICU investigators, 10 Jan 2018, In : Trials. 19, 1, p. 26

    Research output: Contribution to journalJournal articleResearchpeer-review

  25. Published

    Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience

    Zakrzewska, J. M., Palmer, J., Bendtsen, L., Di Stefano, G., Ettlin, D. A., Maarbjerg, S., Obermann, M., Morisset, V., Steiner, D., Tate, S. & Cruccu, G., 2018, In : Trials. 19, 1, p. 704 10 p.

    Research output: Contribution to journalJournal articleResearchpeer-review

  26. 2017
  27. Published

    Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

    Winkel, P., Bath, P. M., Gluud, C., Lindschou, J., van der Worp, H. B., Macleod, M. R., Szabo, I., Durand-Zaleski, I., Schwab, S. & EuroHYP-1 trial investigators, 29 Nov 2017, In : Trials. 18, 1, p. 573

    Research output: Contribution to journalJournal articleResearchpeer-review

  28. Published

    The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial

    Roelsgaard, I. K., Thomsen, T., Østergaard, M., Christensen, R., Hetland, M. L., Jacobsen, S., Andersen, L., Tønnesen, H., Rollefstad, S., Semb, A. G. & Esbensen, B. A., 28 Nov 2017, In : Trials. 18, 1, p. 570-580 11 p.

    Research output: Contribution to journalJournal articleResearchpeer-review

  29. Published

    A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome?

    Rath, A., Salamon, V., Peixoto, S., Hivert, V., Laville, M., Segrestin, B., Neugebauer, E. A. M., Eikermann, M., Bertele, V., Garattini, S., Wetterslev, J., Banzi, R., Jakobsen, J. C., Djurisic, S., Kubiak, C., Demotes-Mainard, J. & Gluud, C., 22 Nov 2017, In : Trials. 18, 1, p. 556

    Research output: Contribution to journalReviewResearchpeer-review

  30. Published

    Text messages to increase attendance to follow-up cervical cancer screening appointments among HPV-positive Tanzanian women (Connected2Care): study protocol for a randomised controlled trial

    Linde, D. S., Andersen, M. S., Mwaiselage, J. D., Manongi, R., Kjaer, S. K. & Rasch, V., 21 Nov 2017, In : Trials. 18, 1, p. e555

    Research output: Contribution to journalJournal articleResearchpeer-review

  31. Published

    iTACTIC - implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a multicentre, randomised controlled trial

    Baksaas-Aasen, K., Gall, L., Eaglestone, S., Rourke, C., Juffermans, N. P., Goslings, J. C., Naess, P. A., van Dieren, S., Ostrowski, S. R., Stensballe, J., Maegele, M., Stanworth, S. J., Gaarder, C., Brohi, K. & Johansson, P. I., 18 Oct 2017, In : Trials. 18, 1, p. 486

    Research output: Contribution to journalJournal articleResearchpeer-review

  32. Published

    The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial

    Bartley, A., Jakola, A. S., Bartek, J., Sundblom, J., Förander, P., Marklund, N. & Tisell, M., 11 Oct 2017, In : Trials. 18, 1, p. 471

    Research output: Contribution to journalJournal articleResearchpeer-review

  33. Published

    PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial

    Thybo, K. H., Jakobsen, J. C., Hägi-Pedersen, D., Pedersen, N. A., Dahl, J. B., Schrøder, H. M., Bulow, H-H., Bjørck, J. G., Overgaard, S., Mathiesen, O. & Wetterslev, J., 10 Oct 2017, In : Trials. 18, 1, p. 465

    Research output: Contribution to journalJournal articleResearchpeer-review

  34. Published

    Specific barriers to the conduct of randomised clinical trials on medical devices

    Neugebauer, E. A. M., Rath, A., Antoine, S-L., Eikermann, M., Seidel, D., Koenen, C., Jacobs, E., Pieper, D., Laville, M., Pitel, S., Martinho, C., Djurisic, S., Demotes-Mainard, J., Kubiak, C., Bertele', V., Jakobsen, J. C., Garattini, S. & Gluud, C., 13 Sep 2017, In : Trials. 18, 1, p. 427

    Research output: Contribution to journalJournal articleResearchpeer-review

  35. Published

    Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

    Laville, M., Segrestin, B., Alligier, M., Ruano-Rodríguez, C., Serra-Majem, L., Hiesmayr, M., Schols, A. M. W. J., La Vecchia, C., Boirie, Y., Rath, A., Neugebauer, E. A. M., Garattini, S., Bertele', V., Kubiak, C., Demotes-Mainard, J., Jakobsen, J. C., Djurisic, S. & Gluud, C., 11 Sep 2017, In : Trials. 18, 1, p. 425

    Research output: Contribution to journalJournal articleResearchpeer-review

  36. Published

    A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

    Hoeffding, L. K., Nielsen, M. H., Rasmussen, M. A., Norup, A., Arango-Lasprilla, J. C., Kjær, U. K., Burgdorf, K. S., Schow, T. & Quas, K. J., 10 Aug 2017, In : Trials. 18, 1, p. 371

    Research output: Contribution to journalJournal articleResearchpeer-review

  37. Published

    Barriers to the conduct of randomised clinical trials within all disease areas

    Djurisic, S., Rath, A., Gaber, S., Garattini, S., Bertele', V., Ngwabyt, S-N., Hivert, V., Neugebauer, E. A. M., Laville, M., Hiesmayr, M., Demotes-Mainard, J., Kubiak, C., Jakobsen, J. C. & Gluud, C., 1 Aug 2017, In : Trials. 18, 1, p. 360

    Research output: Contribution to journalJournal articleResearchpeer-review

  38. Published
  39. Published
  40. Published

    Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

    Glinatsi, D., Heiberg, M. S., Rudin, A., Nordström, D., Haavardsholm, E. A., Gudbjornsson, B., Østergaard, M., Uhlig, T., Grondal, G., Hørslev-Petersen, K., van Vollenhoven, R. & Hetland, M. L., 4 Apr 2017, In : Trials. 18, 1, p. 161

    Research output: Contribution to journalJournal articleResearchpeer-review

  41. Published

    First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial

    Grønhøj, C., Jensen, D. H., Glovinski, P. V., Jensen, S. B., Bardow, A., Oliveri, R. S., Specht, L., Thomsen, C., Darkner, S., Kiss, K., Fischer-Nielsen, A. & von Buchwald, C., 7 Mar 2017, In : Trials. 18, 1, p. e108

    Research output: Contribution to journalJournal articleResearchpeer-review

  42. Published
  43. Published

    PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial

    Thybo, K. H., Hägi-Pedersen, D., Wetterslev, J., Dahl, J. B., Schrøder, H. M., Bülow, H. H., Bjørck, J. G. & Mathiesen, O., 10 Jan 2017, In : Trials. 18, 1, p. 11

    Research output: Contribution to journalJournal articleResearchpeer-review

  44. Published

    Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial

    Berthelsen, R. E., Itenov, T., Perner, A., Jensen, J. U. S., Ibsen, M., Jensen, A. K. & Bestle, M., 2017, In : Trials. 18, 1, p. e189

    Research output: Contribution to journalJournal articleResearchpeer-review

  45. Published

    Perfusion by Arterial Spin labelling following Single dose Taladafil In Small vessel disease (PASTIS): Study protocol for a randomised controlled trial

    Pauls, MH., Natasha, CN., Trippier, S., Betteridge, S., Howe, FA., Khan, U., Kruuse, C., Madigan, JB., Moynihan, B., Pereira, AC., Rolfe, D., Rostrup, E., Haig, CE., Barrick, TR., Isaacs, JD. & Hainsworth, AH., 2017, In : Trials. 18, 1, p. 229-236 8 p.

    Research output: Contribution to journalJournal articleResearchpeer-review

  46. Published

    Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial

    Sandahl, H., Jennum, P., Baandrup, L., Poschmann, I. S. & Carlsson, J., 2017, In : Trials. 18, 1, p. 520

    Research output: Contribution to journalJournal articleResearchpeer-review

  47. 2016
  48. Published

    Recruiting to Clinical Trials on the Telephone - a randomized controlled trial

    Foss, K. T., Kjærgaard, J., Stensballe, L. G. & Greisen, G., 21 Nov 2016, In : Trials. 17, 1, p. 552

    Research output: Contribution to journalJournal articleResearchpeer-review

  49. Published

    Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial

    Fenger, M., Lindschou, J., Gluud, C., Winkel, P., Jørgensen, L. L., Kruse-Blinkenberg, S. & Lau, M., 28 Oct 2016, In : Trials. 17, 1, p. 525

    Research output: Contribution to journalJournal articleResearchpeer-review

  50. Published
  51. Published

    Targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S): study protocol and statistical analysis plan for a randomized controlled trial

    Pettilä, V., Merz, T., Wilkman, E., Perner, A., Karlsson, S., Lange, T., Hästbacka, J., Hjortrup, P. B., Kuitunen, A., Jakob, S. M. & Takala, J., 2 Aug 2016, In : Trials. 17, p. 384

    Research output: Contribution to journalJournal articleResearchpeer-review

  52. Published

    GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial

    Wiberg, S., Hassager, C., Thomsen, J. H., Frydland, M., Høfsten, D. E., Engstrøm, T., Køber, L., Schmidt, H., Møller, J. E. & Kjaergaard, J., 30 Jun 2016, In : Trials. 17, 1, p. 304

    Research output: Contribution to journalJournal articleResearchpeer-review

  53. Published

    A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project

    Mosconi, P., Antes, G., Barbareschi, G., Burls, A., Demotes-Mainard, J., Chalmers, I., Colombo, C., Garattini, S., Gluud, C., Gyte, G., Mcllwain, C., Penfold, M., Post, N., Satolli, R., Valetto, M. R., West, B. & Wolff, S., 2016, In : Trials. 17, 1, p. 19

    Research output: Contribution to journalJournal articleResearchpeer-review

  54. Published
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