VoiceS: voice quality after transoral CO2 laser surgery versus single vocal cord irradiation for unilateral stage 0 and I glottic larynx cancer —a randomized phase III trial
DiscussionTo our knowledge, VoiceS is the first randomized phase III trial comparing SVCI with TLM. Results of this study may lead to improved decision-making in the treatment of ESGC.Trial registrationClinicalTrials.gov NCT04057209. Registered on 15 August 2019. Cantonal Ethics Committee KEK-BE 2019-01506 (Source: Trials)
Source: Trials - October 27, 2022 Category: Research Source Type: clinical trials
Comparison of different concentrations of a povidone iodine-diluted sitz bath in the prevention of perianal infection in patients undergoing chemotherapy for hematological malignancy: study protocol for a randomized controlled trial
This study received full ethics committee approval. The first patient was enrolled on May 1, 2021. A total of 268 patients with hematological malignancies undergoing chemotherapy who have risk factors for perianal infection will be enrolled with informed consent and randomly allocated to one of the four arms receiving (1) perianal cleaning care (control group D), (2) 1:100 PI diluted sitz bath (intervention group A), (3) 1:200 PI diluted sitz bath (intervention group B), and (4) 1:300 PI diluted sitz bath (intervention group C). The primary endpoint of the trial was the incidence of perianal infection. The secondary endpoi...
Source: Trials - October 22, 2022 Category: Research Source Type: clinical trials
Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol
ConclusionBy doing this, we can increase the reporting consistency and reduce the reporting bias in the outcome, which leads to the reuse of research data in meta-analysis and the making of informed healthcare decisions.Ethics and disseminationThe entire project has received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The final COS will be published and reported at the national and international conferences.Trial registrationThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study1475. Registered on December 2019. (Source: Trials)
Source: Trials - October 12, 2022 Category: Research Source Type: clinical trials
Evaluating a tool to improve engagement and recruitment of under-served groups in trials
ConclusionsThere is a need for researchers to consider the funding and time resources required for diverse and inclusive recruitment to trials and for funders to enable this. The INCLUDE Ethnicity Framework can help to raise awareness of inclusion challenges. This study indicates that it is important to take proactive steps to involve relevant under-served groups in PCIE and practical suggestions are made to facilitate this. (Source: Trials)
Source: Trials - October 9, 2022 Category: Research Source Type: clinical trials
Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey
ConclusionsOur modified Delphi process successfully generated seven principles that can and should be used to guide how information is conveyed to patients in information leaflets regarding potential trial benefits and harms. (Source: Trials)
Source: Trials - October 8, 2022 Category: Research Source Type: clinical trials
