Effect of a single-dose denosumab on semen quality in infertile men (the FITMI study): study protocol for a randomized controlled trial
We describe a protocol for a planned RCT aimed at evaluating whether treatment with denosumab can improve the semen quality in infertile men selected by using serum AMH as a positive predictive biomarker. The results will provide evidence crucial for future treatment in a patient group where there is a huge unmet need.Trial registrationClinical Trials.govNCT05212337. Registered on 14 January 2022.EudraCT 2021 –003,451-42. Registered on 23 June 2021.Ethical committee H-21040145. Registered on 23 December 2021. (Source: Trials)
Source: Trials - June 22, 2022 Category: Research Source Type: clinical trials

Protocol paper: multi-Centre randomised controlled trial evaluating a pre-clinic diabetes assessment and mapped care planning intervention amongst adults with type 1, type 2 or pre-diabetes
DiscussionResults from the study will provide valuable insights into patient-professional communication practices within routine care and recommendations will be made, as necessary, for improvements to that. If the intervention is shown to be clinically and cost-effective, the feedback from participants and healthcare professionals will be used to make any improvements prior to its deployment to support improved communication and associated health outcomes.Ethics and disseminationThe trial was approved by the Wales REC7 Research Ethics Committee (21/WA/0020). Results will be disseminated through national and international ...
Source: Trials - June 20, 2022 Category: Research Source Type: clinical trials

Effect of negative pressure wound therapy after surgical removal of deep-seated high-malignant soft tissue sarcomas of the extremities and trunk wall —study protocol for a randomized controlled trial
This study did not apply for external funding.DiscussionMany new medical devices and technical solutions are currently being introduced, and even though some documentation regarding the use of NPWT, e.g., in joint replacement surgery exist, it is also important to seek documentation for this treatment principle in STS surgery.Trial registrationRegistered atClinicalTrials.gov NCT04960332 and approved on 11 July 2021 (Source: Trials)
Source: Trials - June 18, 2022 Category: Research Source Type: clinical trials

Prediction Aided Tapering In rheumatoid arthritis patients treated with biOlogicals (PATIO): protocol for a randomized controlled trial
DiscussionThis will be the first clinical trial to evaluate the benefit of applying a dynamic flare prediction model as a decision aid during bDMARD tapering. Reducing the risk of flaring during tapering may enhance the safety and (cost)effectiveness of bDMARD treatment. Furthermore, this study pioneers the field of implementing predictive algorithms in clinical practice.Trial registrationDutch Trial Register number NL9798, registered 18 October 2021,https://www.trialregister.nl/trial/9798. The study has received ethical review board approval (number NL74537.041.20). (Source: Trials)
Source: Trials - June 16, 2022 Category: Research Source Type: clinical trials

TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II –III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis
DiscussionTB-PRACTECAL is an ambitious trial using adaptive design to accelerate regimen assessment and bring novel treatments that are effective and safe to patients quicker. The trial took a patient-centred approach, adapting to best practice guidelines throughout recruitment. The implementation faced significant challenges from the COVID-19 pandemic. The trial was terminated early for efficacy on the advice of the DSMB and will report on data collected up to the end of recruitment and, additionally, the planned final analysis at 72 weeks after the end of recruitment.Trial registrationClinicaltrials.gov NCT02589782.  Re...
Source: Trials - June 13, 2022 Category: Research Source Type: clinical trials

The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol
This study evaluates the effect of a probiotic on abdominal pain and gastrointestinal symptoms in healthy women who take an oral contraceptive, have regular menses, and typically experience these symptoms during menstruation with the primary aim being change in abdominal pain intensity related to the menstrual cycle with probiotic versus placebo supplementation.Methods and analysisIn this randomized, double-blind, placebo-controlled parallel study, participants will receive either a probiotic or placebo supplement. Participants will begin answering questionnaires approximately 7  days before the start of menstruation (i....
Source: Trials - June 10, 2022 Category: Research Source Type: clinical trials

Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis
AbstractResults from the STREAM stage 1 trial showed that a 9-month regimen for patients with rifampicin-resistant tuberculosis was non-inferior to the 20-month regimen recommended by the 2011 WHO treatment guidelines. Similar levels of severe adverse events were reported on both regimens suggesting the need for further research to optimise treatment. Stage 2 of STREAM evaluates two additional short-course regimens, both of which include bedaquiline. Throughout stage 2 of STREAM, new drug choices and a rapidly changing treatment landscape have necessitated changes to the trial ’s design to ensure it remains ethical and r...
Source: Trials - June 7, 2022 Category: Research Source Type: clinical trials