bluuebunny/crossref_metadata_2025_split huggingface dataset:
Connected device and therapeutic patient education to promote physical
activity among women with localised breast cancer (DISCO trial): protocol
for a multicentre 2×2 factorial randomised controlled trial
Authors: Touillaud Marina , Fournier Baptiste , Pérol Olivia , Delrieu Lidia , Maire Aurélia , Belladame Elodie , Pérol David , Perrier Lionel , Preau Marie , Leroy Tanguy , Fassier Jean-Baptiste , Fillol Florie , Pascal Sébastien , Durand Thierry , Fervers Béatrice 
Published: November 2022

Introduction
Despite safety and benefits of physical activity during treatment of
localised breast cancer, successful exercise strategies remain to be
determined. The primary objective of the ‘dispositif connecté’, that is,
connected device in English trial is to evaluate the efficacy of two
6-month exercise interventions, either single or combined, concomitant
to adjuvant treatments, on the physical activity level of patients with
breast cancer, compared with usual care: an exercise programme using a
connected device (activity tracker, smartphone application, website) and
a therapeutic patient education intervention. Secondary objectives are
to evaluate adherence to interventions, their impact at 6 and 12 months,
representations and acceptability of interventions, and to assess the
cost-effectiveness of the interventions using quality-adjusted
life-years.

Methods and analysis
This is a 2×2 factorial, multicentre, phase III randomised
controlled trial. The study population (with written informed consent)
will consist of 432 women diagnosed with primary localised invasive
breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy
and/or radiotherapy. They will be randomly allocated between one of four
arms: (1) web-based connected device (evolving target number of daily
steps and an individualised, semisupervised, adaptive programme of two
walking and one muscle strengthening sessions per week in autonomy), (2)
therapeutic patient education (one educational diagnosis, two collective
educational sessions, one evaluation), (3) combination of both
interventions and (4) control. All participants will receive the
international physical activity recommendations. Assessments (baseline,
6 and 12 months) will include physical fitness tests, anthropometrics
measures, body composition (CT scan, bioelectrical impedance),
self-administered questionnaires (physical activity profile (Recent
Physical Activity Questionnaire), quality of life (European Organization
for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30,
EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation
(Evaluation of Deprivation and Inequalities in Health Examination
Centres), lifestyle, physical activity barriers, occupational status)
and biological parameters (blood draw).

Ethics and dissemination
This study was reviewed and approved by the French Ethics Committee.
The findings will be disseminated to the scientific and medical
community via publications in peer-reviewed journals and conference
presentations.

Trial registration number
NCT03529383; Pre-results.
Protocol for targeting insomnia in school-aged children with autism
spectrum disorder without intellectual disability: a randomised control
trial
Authors: McCrae Christina S , Mazurek Micah O , Curtis Ashley F , Beversdorf David Q , Deroche Chelsea B , Golzy Mojgan , Sohl Kristin A , Ner Zarah H , Davis Beth Ellen , Stearns Melanie A , Nair Neetu 
Published: November 2022

Introduction
Insomnia affects up to 80% of children with autism spectrum disorder
(ASD). Negative consequences of insomnia in ASD include decreased
quality of life (QOL), impaired learning and cognition, increased
stereotypic and challenging behaviours, and increased parental stress.
Cognitive behavioural treatment for childhood insomnia (CBT-CI) is a
promising treatment for dealing with insomnia and its negative
consequences but has not yet been studied in school-aged children with
ASD and comorbid insomnia. Access to healthcare is another challenge for
children with ASD, particularly in rural and underserved regions.
Previous studies indicate that ASD and insomnia share common
arousal-based underpinnings, and we hypothesise that CBT-CI will reduce
the hyperarousal associated with insomnia and ASD. This trial will be
the first to examine CBT-CI adapted for children with ASD and will
provide new information about two different modes of delivery across a
variety of primary and secondary child and parent sleep and related
outcomes. Knowledge obtained from this trial might allow us to develop
new or modify current treatments to better target childhood insomnia and
ASD.

Methods and analysis
Children (N=180) 6–12 years of age with ASD and insomnia will be
recruited from an established autism database, a paediatric clinic and
community outreach in the Columbia, MO and surrounding areas.
Participants will be randomised to CBT-CI adapted for children with ASD
(in-person or remote using computers with cameras) or Sleep Hygiene and
Related Education. Participants will be assessed at baseline,
post-treatment, 6-month and 12-month follow-ups. The following
assessments will be completed regarding the children: objective and
subjective sleep, daytime functioning (adaptive functioning, attention,
challenging behaviours, anxiety), QOL and physiological arousal (heart
rate variability) and parents: objective and subjective sleep, daytime
functioning (anxiety, depression, fatigue), QOL, physiological arousal
and parental burden/stress.

Ethics and dissemination
Ethics approval was obtained in January 2020 from the University of
Missouri. Ethics approval was obtained in July 2020 from the US Army
Medical Research and Development Command, Office of Research Protections
and Human Research Protection Office. All data are expected to be
collected by 2024. Full trial results are planned to be published by
2025. Secondary analyses of baseline data will be subsequently
published.

Trial registration number
NCT04545606; Pre-results.
Integrating HIV, diabetes and hypertension services in Africa: study
protocol for a cluster randomised trial in Tanzania and Uganda
Authors: Mfinanga Sayoki Godfrey , Nyirenda Moffat J , Mutungi Gerald , Mghamba Janneth , Maongezi Sarah , Musinguzi Joshua , Okebe Joseph , Kivuyo Sokoine , Birungi Josephine , van Widenfelt Erik , Van Hout Marie-Claire , Bachmann Max , Garrib Anupam , Bukenya Dominic , Cullen Walter , Lazarus Jeffrey V , Niessen Louis Wihelmus , Katahoire Anne , Shayo Elizabeth Henry , Namakoola Ivan , Ramaiya Kaushik , Wang Duolao , Cuevas LE , Etukoit Bernard M , Lutale Janet , Meshack Shimwela , Mugisha Kenneth , Gill Geoff , Sewankambo Nelson , Smith Peter G , Jaffar Shabbar 
Published: November 2022

Introduction
HIV programmes in sub-Saharan Africa are well funded but programmes
for diabetes and hypertension are weak with only a small proportion of
patients in regular care. Healthcare provision is organised from
stand-alone clinics. In this cluster randomised trial, we are evaluating
a concept of integrated care for people with HIV infection, diabetes or
hypertension from a single point of care.

Methods and analysis
32 primary care health facilities in Dar es Salaam and Kampala
regions were randomised to either integrated or standard vertical care.
In the integrated care arm, services are organised from a single clinic
where patients with either HIV infection, diabetes or hypertension are
managed by the same clinical and counselling teams. They use the same
pharmacy and laboratory and have the same style of patient records.
Standard care involves separate pathways, that is, separate clinics,
waiting and counselling areas, a separate pharmacy and separate medical
records. The trial has two primary endpoints: retention in care of
people with hypertension or diabetes and plasma viral load suppression.
Recruitment is expected to take 6 months and follow-up is for 12 months.
With 100 participants enrolled in each facility with diabetes or
hypertension, the trial will provide 90% power to detect an absolute
difference in retention of 15% between the study arms (at the 5%
two-sided significance level). If 100 participants with HIV infection
are also enrolled in each facility, we will have 90% power to show
non-inferiority in virological suppression to a delta=10% margin (ie,
that the upper limit of the one-sided 95% CI of the difference between
the two arms will not exceed 10%). To allow for lost to follow-up, the
trial will enrol over 220 persons per facility. This is the only trial
of its kind evaluating the concept of a single integrated clinic for
chronic conditions in Africa.

Ethics and dissemination
The protocol has been approved by ethics committee of The AIDS
Support Organisation, National Institute of Medical Research and the
Liverpool School of Tropical Medicine. Dissemination of findings will be
done through journal publications and meetings involving study
participants, healthcare providers and other stakeholders.

Trial registration number
NCT43896688.
Combined use of a broad-panel respiratory multiplex PCR and procalcitonin
to reduce duration of antibiotics exposure in patients with severe
community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group,
open-label, individual randomised trial conducted in French intensive care
units
Authors: Voiriot Guillaume , Fartoukh Muriel , Durand-Zaleski Isabelle , Berard Laurence , Rousseau Alexandra , Armand-Lefevre Laurence , Verdet Charlotte , Argaud Laurent , Klouche Kada , Megarbane Bruno , Patrier Juliette , Richard Jean-Christophe , Reignier Jean , Schwebel Carole , Souweine Bertrand , Tandjaoui-Lambiotte Yacine , Simon Tabassome , Timsit Jean-François 
Published: November 2022

Introduction
At the time of the worrying emergence and spread of bacterial
resistance, reducing the selection pressure by reducing the exposure to
antibiotics in patients with community-acquired pneumonia (CAP) is a
public health issue. In this context, the combined use of molecular
tests and biomarkers for guiding antibiotics discontinuation is
attractive. Therefore, we have designed a trial comparing an integrated
approach of diagnosis and treatment of severe CAP to usual
care.

Methods and analysis
The multiplex PCR and procalcitonin to reduce duration of
antibiotics exposure in patients with severe-CAP (MULTI-CAP) trial is a
multicentre (n=20), parallel-group, superiority, open-label, randomised
trial. Patients are included if adult admitted to intensive care unit
for a CAP. Diagnosis of pneumonia is based on clinical criteria and a
newly appeared parenchymal infiltrate. Immunocompromised patients are
excluded. Subjects are randomised (1:1 ratio) to either the intervention
arm (experimental strategy) or the control arm (usual strategy). In the
intervention arm, the microbiological diagnosis combines a respiratory
multiplex PCR (mPCR) and conventional microbiological investigations. An
algorithm of early antibiotic de-escalation or discontinuation is
recommended, based on mPCR results and the procalcitonin value. In the
control arm, only conventional microbiological investigations are
performed and antibiotics de-escalation remains at the clinician’s
discretion. The primary endpoint is the number of days alive without any
antibiotic from the randomisation to day 28. Based on our hypothesis of
2 days gain in the intervention arm, we aim to enrol a total of 450
patients over a 30-month period.

Ethics and dissemination
The MULTI-CAP trial is conducted according to the principles of the
Declaration of Helsinki, is registered in Clinical Trials and has been
approved by the Committee for Protection of Persons and the National
French Drug Safety Agency. Written informed consents are obtained from
all the patients (or representatives). The results will be disseminated
through educational institutions, submitted to peer-reviewed journals
for publication and presented at medical congresses.

Trial registration number
NCT03452826; Pre-results.
Protocol for a case–control study investigating the clinical phenotypes
and genetic regulation of endometriosis in Indian women: the ECGRI
study
Authors: Gajbhiye Rahul K. , Montgomery Grant , Pai Murlidhar V , Phukan Pranay , Shekhar Shashank , Padte Kedar , DasMahapatra Pramathes , John Bimal M. , Shembekar Chaitanya , Bhurke Aishwarya V. , Bagde Nilajkumar , Kulkarni Ketki , Sardeshpande Nagendra , Humane Anil , Mahobia Swati , Shah Millind , Singh Uma , Srivastava Aarti , Mishra Gita , Warty Neeta , Chandra Sunita , Mahale Smita D. 
Published: November 2022

Introduction
Endometriosis is one of the common, gynaecological disorders
associated with chronic pelvic pain and subfertility affecting ~10% of
reproductive age women. The clinical presentation, etiopathogenesis of
endometriosis subtypes and associated risk factors are largely unknown.
Genome-Wide Association (GWA) Studies (GWAS) provide strong evidence for
the role of genetic risk factors contributing to endometriosis. However,
no studies have investigated the association of the GWAS-identified
single-nucleotide polymorphism (SNPs) with endometriosis risk in the
Indian population; therefore, one-sixth of the world’s population is not
represented in the global genome consortiums on endometriosis. The
Endometriosis Clinical and Genetic Research in India (ECGRI) study aims
to broaden our understanding of the clinical phenotypes and genetic
risks associated with endometriosis.

Methods and analysis
ECGRI is a large-scale, multisite, case–control study of 2000
endometriosis cases and 2000 hospital controls to be recruited over 4
years at 15 collaborating study sites across India covering
representative Indian population from east,north-east, north, central,
west and southern geographical zones of India. We will use the World
Endometriosis Research Foundation Endometriosis Phenome and Biobanking
Harmonisation Project (WERF-EPHect) data collection instruments for
capturing information on clinical, epidemiological, lifestyle,
environmental and surgical factors. WERF-EPHect standard operating
procedures will be followed for the collection, processing and storage
of biological samples. The principal analyses will be for main outcome
measures of the incidence of endometriosis, disease subtypes and disease
severity determined from the clinical data. This will be followed by
GWAS within and across ethnic groups.

Ethics and dissemination
The study is approved by the Institutional Ethics Committee of
Indian Council of Medical Research-National Institute for Research in
Reproductive Health and all participating study sites. The study is also
approved by the Health Ministry Screening Committee of the Government of
India. The results from this study will be actively disseminated through
discussions with endometriosis patient groups, conference presentations
and published manuscripts.
Single session compared with multiple sessions of education and exercise
for older adults with spinal pain in an advanced practice physiotherapy
model of care: protocol for a randomised controlled trial
Authors: Lafrance Simon , Santaguida Carlo , Perreault Kadija , Bath Brenna , Thavorn Kednapa , Feldman Debbie , Hébert Luc J , Fernandes Julio , Desmeules François 
Published: November 2022

Objectives
To assess the effectiveness and cost-effectiveness of a single
session compared with multiple sessions of education and exercise for
older adults with spinal pain treated conservatively in an advanced
practice physiotherapy model of care.

Methods and analysis
In this pragmatic randomised controlled trial, 152 older adults (≥65
years old) with neck or back pain initially referred for a consultation
in neurosurgery, but treated conservatively, will be recruited through
the advanced practice physiotherapy neurosurgery CareAxis programme in
the Montreal region (Quebec, Canada). In the CareAxis programme, older
patients with spinal pain are triaged by an advance practice
physiotherapist and are offered conservative care and only potential
surgical candidates are referred to a neurosurgeon. Participants will be
randomised into one of two arms: 1—a single session or 2—multiple
sessions (6 sessions over 12 weeks) of education and exercise with the
advance practice physiotherapist (1:1 ratio). The primary outcome
measure will be the Brief Pain Inventory (pain severity and interference
subscales). Secondary measures will include self-reported disability
(the Neck Disability Index or Oswestry Disability Index), the Pain
Catastrophizing Scale, satisfaction with care questionnaires (9-item
Visit-specific Satisfaction Questionnaire and MedRisk), and the
EQ-5D-5L. Participants’ healthcare resources use and related costs will
be measured. Outcomes will be collected at baseline and at 6, 12 and 26
weeks after enrolment. Intention-to-treat analyses will be performed,
and repeated mixed-model analysis of variance will assess differences
between treatment arms. Cost-utility analyses will be conducted from the
perspective of the healthcare system.

Ethics and dissemination
Ethics approval has been obtained from theComité
d’éthique de la recherche du CIUSS de
l’Est-de-l’Île-de-Montréal(FWA00001935 and
IRB00002087). Results of this study will be presented to different
stakeholders, published in peer-reviewed journals and presented at
international conferences.

Protocol version
V.4 August 2021.

Trial registration number
NCT04868591; Pre-results.
Functional recovery following hospitalisation of patients diagnosed with
COVID-19: a protocol for a longitudinal cohort study
Authors: Reid Julie C , Costa Andrew P , Duong MyLinh , Ho Terence , Kruisselbrink Rebecca , Raina Parminder , Kirkwood Renata , Jones Aaron , Corriveau Sophie , Griffith Lauren E , Haider Shariq , Marcucci Maura , Markle-Reid Maureen , Morrison Hope , Raghavan Natya , Schumacher Connie , Vrkljan Brenda , Junek Mats , Martin Leslie , Patel Ameen , Girolametto Carla , Pitre Tyler , Beauchamp Marla K 
Published: November 2022

Introduction
COVID-19 is an international public health crisis with more than 132
million infections worldwide. Beyond acute infection, emerging data
indicate patients diagnosed with COVID-19 may experience persistent
sequelae similar to survivors of sepsis or acute respiratory syndromes,
including mobility limitations and fatigue. However, there is limited
evidence on the trajectory of functional recovery in those hospitalised
with COVID-19. The primary aim of the Coronavirus Registry Functional
Recovery (COREG-FR) study is to understand the trajectory of functional
recovery among individuals hospitalised for COVID-19 over the medium (up
to 6 months) and longer term (6–12 months) that will guide clinical care
and optimal management of serious COVID-19 illness and
recovery.

Methods and analysis
COREG-FR is a multicentre longitudinal cohort study. We will enrol a
minimum of 211 adults age 18 years and older with COVID-19 from five
hospitals. Participants will be followed from admission to hospital as
an inpatient, to hospital discharge, and at 3-month, 6-month, 9-month
and up to 12-month post-hospital discharge. We will conduct telephone
interviews at ward admission and discharge, and telephone interviews
plus in-person assessments of physical function and lung function at all
remaining follow-ups. Our primary outcome is the Activity Measure for
Post-Acute Care mobility scale measured at all time points. We will
conduct linear mixed effects regression analyses to explore determinants
of functional outcomes after COVID-19 illness. Subgroup analyses based
on age (≤65 vs >65 years), frailty status (Clinical Frailty Scale
score ≤4 vs >5) and variants of concern will be conducted.

Ethics and dissemination
COREG-FR has been approved by Research Ethics Boards at
participating sites. We will disseminate this work through peer-reviewed
manuscripts, presentations at national and international meetings and
through the established COREG website (www.coregontario.ca). COREG-FR is designed as a data
platform for future studies evaluating COVID-19 recovery.

Trial registration number
NCT04602260; Pre-results.
Immediate versus postponed single blastocyst transfer in modified natural
cycle frozen embryo transfer (mNC-FET): a study protocol for a multicentre
randomised controlled trial
Authors: Bergenheim Sara Johanna , Saupstad Marte , Pistoljevic Nina , Lyng Forman Julie , Larsen Elisabeth Clare , Bogstad Jeanette Wulff , Fynbo Malene , Hashem Nadia , Freiesleben Nina La Cour , Nøhr Bugge , Andersen Lars Franch , Humaidan Peter , Ziebe Soren , Pinborg Anja Bisgaard , Løssl Kristine 
Published: November 2022

Introduction
Today, it is widespread practice to postpone frozen embryo transfer
(FET) in a modified natural cycle (mNC) for at least one menstrual cycle
after oocyte retrieval and failed fresh embryo transfer or freeze-all.
The rationale behind this practice is the concern that suboptimal
ovarian, endometrial or endocrinological conditions following ovarian
stimulation may have a negative impact on endometrial receptivity and
implantation. However, two recent systematic reviews and meta-analyses
based on retrospective data did not support this practice. As
unnecessary delay in time to transfer and pregnancy should be avoided,
the aim of this study is to investigate if immediate single blastocyst
transfer in mNC-FET is non-inferior to standard postponed single
blastocyst transfer in mNC-FET in terms of live birth rate.

Methods and analysis
Multicentre randomised controlled non-blinded trial including 464
normo-ovulatory women aged 18–40 years undergoing single blastocyst
mNC-FET after a failed fresh or freeze-all cycle. Participants are
randomised 1:1 to either FET in the first menstrual cycle following the
stimulated cycle (immediate FET) or FET in the second or subsequent
cycle following the stimulated cycle (postponed FET). The study is
designed as a non-inferiority trial and primary analyses will be
performed as intention to treat and per protocol.

Ethics and dissemination
Ethical approval has been granted by the Scientific Ethical
Committee of the Capital Region of Denmark (J-nr.: H-19086300). Data
will be handled according to Danish law on personal data protection in
accordance with the general data protection regulation. Participants
will complete written consent forms regarding participation in the study
and storage of blood samples in a biobank for future research. The study
will be monitored by a Good Clinical Practice (GCP)-trained study nurse
not otherwise involved in the study. The results of this study will be
disseminated by publication in international peer-reviewed scientific
journals.

Trial registration number
NCT04748874; Pre-results.