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Cenduit GmbH randomisation
Randomisation, supplied by Cenduit GmbH, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
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Article Title: Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial
Article Snippet: The randomisation list was created by Cenduit (Durham, NC, USA) and reviewed and approved by Novartis Biostatistics Quality Assurance Group.

Article Title: Safety and efficacy of dimethyl fumarate in ALS: randomised controlled study
Article Snippet: All randomisation procedures were managed by a third‐party vendor (Cenduit, India).

Article Title: Safety and efficacy of peficitinib in Asian patients with rheumatoid arthritis who had an inadequate response or intolerance to methotrexate: results of a multicenter, randomized, double-blind, placebo-controlled phase 3 study
Article Snippet: The randomization list and study medication blind were provided and maintained by a web-based randomization system provided by an independent vendor (Cenduit).

Article Title: Efficacy and safety of pegzilarginase in arginase 1 deficiency (PEACE): a phase 3, randomized, double-blind, placebo-controlled, multi-centre trial
Article Snippet: The computer-generated randomization schedule was provided to the Interactive Response Technology vendor (Cenduit [Durham NC, USA]) in which the randomization was executed during the study.

Article Title: Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder.
Article Snippet: Department of Urology, En Chu Kong Hospital, College of Medicine, National Taiwan University, New Taipei City, Taiwan Department of Biomedical Engineering, Chung Yuan Christian University, Taoyuan, Taiwan Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, and Buddhist Tzu Chi University, Hualien, Taiwan Department of Statistics, National Taipei University, New Taipei City, Taiwan

Sequencing:

Article Title: Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial
Article Snippet: Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China (Prof Y-L Wu MD, Prof J-J Yang MD); Department of Surgery, Oncology and Gastroenterology, University of Padova, Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy (Prof V Guarneri PhD); Hospital Umum Sarawak, Kuching, Sarawak, Malaysia (P J Voon MD); Department of Internal and Respiratory Medicine, Sunway Medical Centre, Selangor, Malaysia (B K Lim MRCP); Service de Pneumologie, Hôpital Cochin, Assistance Publique—Hôpitaux de Paris, Paris, France (Prof M Wislez PhD); Université Paris Cité, Paris, France (Prof M Wislez); Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China (Prof C Huang PhD); Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (Prof C K Liam MBBS [UM]); CHU de Toulouse, Université Paul Sabatier, Toulouse, France (Prof J Mazieres PhD); Department of Oncology, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia (L M Tho PhD); Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan (Prof H Hayashi PhD); National Lung Hospital, University of Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial

Article Title: Efficacy assessment of an active tau immunotherapy in Alzheimer's disease patients with amyloid and tau pathology: a post hoc analysis of the "ADAMANT" randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial.
Article Snippet: Published Online xxx https://doi.org/10.. 1016/j.ebiom.2023.. 104923 Efficacy assessment of an active tau immunotherapy in Alzheimer’s disease patients with amyloid and tau pathology: a post hoc analysis of the “ADAMANT” randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial Nicholas C. Cullen, Petr Novak,b,∗ Duygu Tosun, Branislav Kovacech, Jozef Hanes, Eva Kontsekova, Michal Fresser, Stefan Ropele, Howard H. Feldman, Reinhold Schmidt, Bengt Winblad, and Norbert Zilka

Generated:

Article Title: Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial
Article Snippet: Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China (Prof Y-L Wu MD, Prof J-J Yang MD); Department of Surgery, Oncology and Gastroenterology, University of Padova, Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy (Prof V Guarneri PhD); Hospital Umum Sarawak, Kuching, Sarawak, Malaysia (P J Voon MD); Department of Internal and Respiratory Medicine, Sunway Medical Centre, Selangor, Malaysia (B K Lim MRCP); Service de Pneumologie, Hôpital Cochin, Assistance Publique—Hôpitaux de Paris, Paris, France (Prof M Wislez PhD); Université Paris Cité, Paris, France (Prof M Wislez); Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China (Prof C Huang PhD); Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (Prof C K Liam MBBS [UM]); CHU de Toulouse, Université Paul Sabatier, Toulouse, France (Prof J Mazieres PhD); Department of Oncology, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia (L M Tho PhD); Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan (Prof H Hayashi PhD); National Lung Hospital, University of Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial

Article Title: Efficacy assessment of an active tau immunotherapy in Alzheimer's disease patients with amyloid and tau pathology: a post hoc analysis of the "ADAMANT" randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial.
Article Snippet: Published Online xxx https://doi.org/10.. 1016/j.ebiom.2023.. 104923 Efficacy assessment of an active tau immunotherapy in Alzheimer’s disease patients with amyloid and tau pathology: a post hoc analysis of the “ADAMANT” randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial Nicholas C. Cullen, Petr Novak,b,∗ Duygu Tosun, Branislav Kovacech, Jozef Hanes, Eva Kontsekova, Michal Fresser, Stefan Ropele, Howard H. Feldman, Reinhold Schmidt, Bengt Winblad, and Norbert Zilka

Produced:

Article Title: Erenumab versus topiramate for the prevention of migraine – a randomised, double-blind, active-controlled phase 4 trial
Article Snippet: .. Cenduit produced the randomisation list, provided the IRT and allocated the participants to the groups. .. Novartis provided the investigational medicinal products in a double-dummy setting.



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AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.

Journal: ERJ Open Research

Article Title: Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network

doi: 10.1183/23120541.00719-2025

Figure Lengend Snippet: AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.

Article Snippet: Randomisation will be done via the centrally controlled, web-based, GCP-compliant randomisation system, Tayside Randomisation System (TRuST), run by the Health Informatics Centre (University of Dundee), with allocation provided via email.

Techniques: Control, Activity Assay, Comparison