Trials

01 20 October 2026

DOI 10.1186/s13063-026-10022-z

ABCD-Trial: study protocol for a randomized, double-blind, placebo-controlled study in patients with Amyotrophic lateral sclerosis for the evaluation of efficacy and safety of B-Cell Depletion with rituximab (ABCD)

Open DOI

Friederike Ufer, Rosa Rössling, Annika Spottke et al.

Background: The exact disease-causing mechanisms in ALS remain incompletely understood. A possible cause is inflammation of neurons. Compared to other neurodegenerative diseases, neuroinflammation is pronounced in ALS, presumably leading...

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02 19 October 2026

DOI 10.1186/s13063-026-10031-y

AgeX trials of extending the breast screening age range: study protocol for the follow-up phase (2025–2033)

Open DOI

Abdel Babiker, Stephen MacMahon, Alison Halliday et al.

Background: In England, the NHS breast screening programme routinely invites women aged 50–70 years for triennial digital mammography. While screening may reduce breast cancer mortality, it may also lead to overdiagnosis and unnecessary ...

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03 18 October 2026

DOI 10.1186/s13063-026-10049-2

Correction: Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial

Open DOI

Shuang Liu, Jin-Tao Liu, Lin Chen et al.

04 17 October 2026

DOI 10.1186/s13063-026-09989-6

Understanding underserved and underrepresented populations in European clinical studies: a narrative review with systematic approach

Open DOI

Nikoletta Georgiou, Adrita Kaiser, Ulrik B. Kirk et al.

05 16 October 2026

DOI 10.1186/s13063-026-10043-8

A practical framework for exploring non-linear dose–response using adherence data in complex interventions

Open DOI

Mollie Payne, Amy Hardy, Ben Carter et al.

Background: Randomised trials of complex interventions commonly estimate the effect of being offered treatment using intention-to-treat (ITT) analyses. However, in many settings, particularly psychological therapies, participants adhere ...

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06 16 October 2026

DOI 10.1186/s13063-026-10024-x

Effect of a T4 erector spinae plane block on post-thoracoscopic shoulder pain: protocol for an assessor-blinded randomized controlled trial using ropivacaine and dexamethasone

Open DOI

Bucheng Liao, Xueqin Qi, Jiexiong Li et al.

07 15 October 2026

DOI 10.1186/s13063-026-10003-2

Dynamic regularized borrowing—an approach for binary outcomes in single‑arm trials

Open DOI

Mohamad Hasan, Kate Stromberg, Zhilong Yuan et al.

Single-arm clinical trials with binary outcomes often face enrollment challenges, particularly in rare diseases and oncology, where limited sample sizes can reduce estimation precision. Borrowing information from historical trials can im...

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08 15 October 2026

DOI 10.1186/s13063-026-10035-8

Efficacy of a smartphone digital therapeutic (re-R) for post-total knee arthroplasty rehabilitation: study protocol for a single-center randomized controlled trial in the Republic of Korea

Open DOI

Sung-Yeon Oh, Yeon-Gyo Nam

09 15 October 2026

DOI 10.1186/s13063-026-10045-6

Economic evaluation protocol of the Ntshembo (Hope) Trial (RCT) in rural and urban South Africa: an intervention to optimise adolescence body mass index (BMI) pre-conception to address the triple burden of malnutrition

Open DOI

Cyril Bernsah Fonka, Dhyan Saravanja, Shane A Norris et al.

10 14 October 2026

DOI 10.1186/s13063-026-10050-9

Correction: Protocol for a randomized controlled trial comparing saturated and unsaturated fat sources of a ketogenic diet (KETO-IM) investigating cardiovascular, inflammatory and immune function outcomes in adults living with overweight and prediabetes or type 2 diabetes in Edmonton, Canada

Open DOI

Jodie L. Fulton, Trina Gartke, Paulina Blanco Cervantes et al.