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☐ ☆ ✇ BMJ Open

Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS

Por: Trad · G. · Lenglet · T. · Ledoux · I. · Querin · G. · Blancho · S. · Marchand-Pauvert · V. · Hogrel · J.-Y. · Pradat · P.-F. — Enero 16th 2026 at 18:44
Introduction

Robotic rehabilitation on locomotion is a new approach in amyotrophic lateral sclerosis (ALS) and previous studies showed its feasibility. In this study, we aim to evaluate safety, patient’s experience and efficacy of a gait training programme with the Atalante exoskeleton, compared with usual care, on walking ability, functional capacity and other symptoms associated with ALS.

Methods and analysis

EXALS is a monocentric, prospective, interventional, open trial. 20 slowly progressing patients with gait deficits will be recruited. The study is conducted in three phases, each lasting 6 weeks, following the ABA procedure. Phase B represents the intervention phase, during which patients practise their gait training at a rhythm of three sessions/week, as an add-on to usual care. In the two phases A, patients receive usual care with no additional treatment. An evaluation is planned before, in the middle and at the end of each phase. The primary outcome of the study is safety and tolerability of the Atalante exoskeleton. Secondary outcomes include: participants’ subjective impact and experience, attitude and motivation, efficacy and interactivity of the exoskeleton, walking ability, functional capacity, spasticity, balance, postural stability, lower limb muscle strength, quality of life, pain, fatigue, anxiety and depression. Statistical analyses will include descriptive methods for all variables and adverse events. Quantitative outcomes are analysed using repeated-measures ANOVA (analysis of variance) across the seven visits, with post hoc tests applied when appropriate. Nominal outcomes are evaluated using Cochran’s Q test with McNemar pairwise comparisons when significant. Associations between variables are examined using Spearman correlation coefficients. Missing data will be replaced using linear interpolation, and sensitivity analyses will be planned. Qualitative interview data are analysed using thematic analysis.

Ethics and dissemination

This study was approved by the French ethics committee CPP Nord-Ouest I (no. 23.02378.000201). Participant data are anonymised and securely stored in the laboratory’s database, accessible only to the research team. Results will be disseminated through peer-reviewed journals and conferences.

NCT06199284.

☐ ☆ ✇ BMJ Open

Keratorefractive lenticule extraction (KLEx) versus femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for the treatment of myopia and compound myopic astigmatism: study protocol of a randomised clinical trial in Mexico

Por: Muleiro-Alvarez · M. · Vera-Duarte · G. R. · Medina-Estrada · E. A. · Ortiz-Morales · G. · Ramirez-Miranda · A. · Navas · A. · Graue-Wiechers · E. L. · Graue-Hernandez · E. O. · Kahuam-Lopez · N. — Diciembre 23rd 2025 at 10:35
Introduction

Kerato-lenticule extraction (KLEx) is a refractive surgery technique that, in contrast with femtosecond laser-assisted in situ keratomileusis (FS-LASIK), does not require the creation of a flap to correct refractive defects. The potential advantages of this technique are related to the absence of a flap and its complications. On the other hand, FS-LASIK is the most widely practised refractive surgery worldwide, as it offers excellent visual outcomes and is currently the gold standard of refractive surgery. The objective of this study is to compare the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or myopic astigmatism.

Methods and analysis

This double-masked, parallel-group, single-centre randomised clinical trial will enrol 80 eyes from adults with myopia or compound myopic astigmatism within the ranges sphere –0.50 to –12.00 D and cylinder –0.50 to –6.00 D, recruited at the Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico. Participants will be allocated to KLEx or FS-LASIK and assessed at baseline and 1 day, 1 week, 1, 3, 6 and 12 months postoperatively. The primary outcome is uncorrected visual acuity at all postoperative visits. Secondary outcomes include postoperative spherical equivalent, best-corrected visual acuity (BCVA), loss of ≥2 BCVA lines, the proportion of eyes within ±0.50 D of the refractive target, corneal aberrations over a 5 mm pupil, epithelial changes and adverse events. Participants and outcome assessors will be masked to the assigned surgical technique.

Ethics and dissemination

Participant confidentiality will be maintained with the publication of results. This study was approved by the research and ethics committee of the Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana (CI-017-2024). The study results will be disseminated in scientific articles published in peer-reviewed journals and presented through research posters at national and international conferences.

Trial registration number

ClinicalTrials.gov registry (NCT06477081).

☐ ☆ ✇ BMJ Open

Robot-assisted versus standard laparoscopic approach of total hysterectomy for deep infiltrating endometriosis and adenomyosis (ENDORAS TRIAL): study protocol for a randomised controlled trial

Por: Renso · M. · Bendifallah · S. · Estrade · J.-P. · Merlot · B. · Roman · H. · Vidal · F. · Collinet · P. — Noviembre 28th 2025 at 18:14
Introduction

Endometriosis affects 5–10% of women during reproductive years, with a 20–30% incidence among those with infertility. Deep infiltrating endometriosis (DIE) affects 10–15% of women of childbearing age and 50% of infertile women. When hormonal therapy and conservative surgery prove ineffective, total hysterectomy with or without bilateral salpingo-oophorectomy may be the ultimate therapeutic option. Laparoscopic surgery is the gold standard for treating endometriosis, offering effective disease eradication, safety, reduced pain, shorter hospital stay and faster recovery compared with laparotomy. However, patients undergoing total laparoscopic hysterectomy with DIE have higher risks of complications and organ damage, particularly urinary tract damage. Robot-assisted laparoscopic hysterectomy has emerged as a promising alternative, with a significantly lower conversion rate than total laparoscopic hysterectomy in patients with endometriosis. This study evaluates the safety and efficacy of robot-assisted total laparoscopic hysterectomy (RATLH) versus total laparoscopic hysterectomy (TLH) in the management of DIE. We hypothesise that robot-assisted laparoscopic hysterectomy will result in fewer complications and better outcomes compared with total laparoscopic hysterectomy in DIE patients.

Methods and analysis

The ENDORAS trial is a prospective, multicentre, open-label, randomised controlled trial conducted in French reference hospitals specialising in endometriosis surgery. A total of 224 adult women patients will be enrolled in this study if they have DIE with adenomyosis, and without digestive tract involvement as confirmed by MRI. Participants will be randomised to undergo either RATLH or TLH. The primary outcome will be the intraoperative and postoperative complication rates, classified according to the Clavien-Dindo classification (grade 2 or above) at the 3-month postoperative follow-up. Among the secondary outcomes, we will evaluate the quality of life using various questionnaires, including the Endometriosis Health Profile-30, the Short Form-306 and the Female Sexual Function Index.

Ethics and dissemination

The ENDORAS trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practice guidelines. All trial documents and procedures have been reviewed and approved by the Ethics Committee Ile de France II (approval ID number: 24.01408.000300). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.

Trial registration number

NCT06445179. Registered on 14 November 2024.

☐ ☆ ✇ PLOS ONE Medicine&Health

Screening for asymptomatic mpox in at-risk populations: A cross-sectional study

by Inés Armenteros-Yeguas, Reynaldo Homen, Adrián Valls, Laura Dans, Eva Orviz, Oskar Ayerdi, Teresa Puerta, Mar Vera, Jorge Alfredo Pérez-García, Montserrat Torres, Mayte Coiras, Jorge Del Romero, Vicente Estrada

Background

Mpox is a viral disease caused by an orthopoxvirus called monkeypox virus. It experienced a significant increase in cases in 2022 worldwide, mostly with sexual transmission. The possibility of hidden circulation of this infection among asymptomatic individuals remains unclear.

Methods

This is a multi-centre, observational cross-sectional study conducted in a sexually transmitted infections (STIs) clinic in its referral hospital between July and October 2023 in Madrid, Spain. Pharyngeal and rectal swab samples were collected from each participant and processed to detect bacterial STIs and mpox. Socio-demographic, clinical and behavioural data were collected, and a descriptive analysis was performed.

Results

A total of 343 asymptomatic participants were included. The prevalence of asymptomatic mpox infection was 0.3% (n = 1) and the only positive case developed symptoms shortly after sampling, ruling out a fully asymptomatic infection. The percentage of vaccinated individuals was 36.1%. 13.2% had previously contracted mpox. Other STIs were detected in 21.6% of participants.

Conclusions

Although routine screening for asymptomatic bacterial sexually transmitted infections is strongly recommended in at-risk individuals, testing for asymptomatic mpox should be evaluated based on the specific context and population. Additionally, the ongoing cases of mpox in Spain are likely not related to the presence of asymptomatic carriers.

☐ ☆ ✇ BMJ Open

Assessing tuberculosis infection prevalence and test concordance in high-risk groups: a cross-sectional study in Mexicali, Baja California

Por: Brumwell · A. · Herrera · R. · Contreras · K. · Lee · M. · Becerra · E. · Estrada-Guzman · J. · Nicholson · T. · Machado Contreras · R. · Brooks · M. B. — Septiembre 15th 2025 at 05:56
Background

Despite low sensitivity and implementation challenges, the tuberculin skin test (TST) remains the standard-of-care tuberculosis (TB) infection test in Mexico. Interferon gamma release assays (IGRA) may overcome TST-related challenges. Within the confines of the local programmatic setting, this cross-sectional study evaluated the prevalence of TB infection (TBI) and concordance of TST and IGRA in three high-risk populations in Mexicali, Baja California, Mexico.

Methods

Household contacts (HHC) of individuals with TB, people who use drugs (PWUD), people deprived of liberty (PDL) and prison employees underwent evaluation for TBI using TST and QIAreach, a novel IGRA. Prevalence of infection, concordance of test results and reactivity trends of time-to-results (TTR) by TST-induration size were assessed.

Results

In total, 214 of 411 (52.07%) people who had TST and 269 of 460 (58.48%) people who had IGRA tested positive for TBI. Frequency of infection varied across risk groups (HHC 29 (29.6%); PWUD 67 (70.53%); PDL 111 (56.06%) and prison employees 7 (35.0%), p20 mm, p=0.05).

Conclusion

All risk groups had a high frequency of TBI, necessitating locally tailored guidelines for screening, treatment and management of TBI to optimise care for vulnerable populations.

☐ ☆ ✇ Evidentia

Evolución del papel de enfermería en el implante coclear

Por: e11356 / · Francisco de Asís Merchán Pérez · Raquel Morales Estrada — Enero 26th 2019 at 01:00

El implante coclear tiene cada vez mayor aplicación práctica en medicina. Diversos estudios demuestran los beneficios de una implantación más prematura. Explicaremos la ampliación de criterios de colocación, las nuevas pautas en preservación de audición residual, las nuevas técnicas quirúrgicas, las mejoras del material, farmacología y el papel de enfermería en dicho proceso. Objetivo principal: Recopilar los avances en conservación de audición residual y elaborar un protocolo de actuación para enfermería. Metodología: Búsqueda bibliográfica de artículos en PUBMED y CUIDEN. Tras una lectura crítica, se realizó una revisión de los mismos comparándolos con nuestra experiencia. Resultados principales: A mayor audición residual, los implantes cocleares obtienen mejores datos de audición. Conclusión principal: La conservación de la audición residual es capital en la mejora de la audición y enfermería juega un papel fundamental durante todo el proceso.

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