Innovative population-based strategies for primary prevention of cardiovascular disease: A 2-year randomised control trial evaluating behavioral change led by community champions versus brief advice.

Cardiovascular diseases (CVD) caused 17.9 million deaths worldwide in 2019. General CVD prevention should be developed whilst controlling health expenditure.

A smartphone coaching program ("Bouge Grossesse") improves daily physical activity in pregnant women.

Background: Physical activity has been shown to reduce obstetrical risks however pregnant women reduce their physical activity and sedentary behaviors increase.

Objective: Our aim was to evaluate the impact of a smartphone application developed to increase daily physical activity in pregnant women.

Methods: We enrolled 250 pregnant women in a prospective randomized controlled study.

Sexual dysfunction in cystic fibrosis.

Background: Sexual dysfunction (erectile dysfunction in males, sexual dissatisfaction, sexual interest/arousal disorders, and dyspareunia in females) has not been the subject of indepth research in people with cystic fibrosis (CF). This study aimed to determine the prevalence of sexual dysfunction in adults with CF, factors associated with sexual dysfunction, and the impact of sexual dysfunction on quality of life.

Method: We conducted a multicentre study in adults with cystic fibrosis followed in specialist centres in Western France.

Abatacept in early polymyalgia rheumatica (ALORS): a proof-of-concept, randomised, placebo-controlled, parallel-group trial.

Background: Medium-dose glucocorticoids can improve symptoms in nearly all patients with polymyalgia rheumatica. According to its good safety profile, abatacept could be used instead of glucocorticoids in early polymyalgia rheumatica. We aimed to determine whether the efficacy of abatacept is sufficient to justify larger studies in early polymyalgia rheumatica.

[F]FDG PET/CT for therapeutic assessment of Abatacept in early-onset polymyalgia rheumatica.

Purpose: Evaluate the benefit of 2-deoxy-2-[18F]-fluoro-D-glucose ([F] FDG) positron emission tomography/computed tomography (PET/CT) for the therapeutic assessment of Abatacept (ABA) as first-line therapy in early-onset polymyalgia rheumatica (PMR) patients.

Methods: This was an ancillary study of ALORS trial (Abatacept in earLy Onset polymyalgia Rheumatica Study) assessing the ability of ABA versus placebo to achieve low disease activity (C-Reactive Protein PMR activity score (CRP PMR-AS) ≤ to 10) without glucocorticoid (GC) at week 12 in patients with early-onset PMR. The patients underwent [F] FDG PET/CT at baseline and after 12 weeks of treatment.

Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial.

Importance: Intensive interventions are provided to young children with unilateral cerebral palsy (UCP), classically focused on the upper extremity despite the frequent impairment of gross motor function. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) effectively improves manual dexterity and gross motor function in school-aged children.

Objective: To verify if HABIT-ILE would improve manual abilities in young children with UCP more than usual motor activity.

Prevalence and severity of functional urinary and anorectal disorders and their impact on quality of life in cystic fibrosis.

Background: In cystic fibrosis (CF), coughing is associated with a risk of pelvic floor dysfunction. However, data on the prevalence of symptoms (stress urinary incontinence, bladder overactivity, dysuria, and faecal incontinence) are lacking in males and females with CF. The impact of incontinence on adherence to respiratory care has not been studied.

Family history of postpartum hemorrhage is a risk factor for postpartum hemorrhage after vaginal delivery: results from the French prospective multicenter Haemorrhages and Thromboembolic Venous Disease of the Postpartum cohort study.

Background: Postpartum hemorrhage is a major component of perinatal morbidity and mortality that affects young women worldwide and is still often unpredictable. Reducing the incidence of postpartum hemorrhage is a major health issue and identifying women at risk for postpartum hemorrhage is a key element in preventing this complication.

Objective: This study aimed to estimate postpartum hemorrhage prevalence after vaginal delivery and to identify postpartum hemorrhage risk factors.

Evaluation of the efficacy of HEMOlife®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial.

Background: Preventing ischemia‒reperfusion injury (IRI) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRI is delayed graft function (DGF). Hypoxia is one of the key factors in IRI, suggesting that the use of an oxygen carrier as an additive to preservation solution may be useful.

Development and Validation of a Predictive Tool for Postpartum Hemorrhage after Vaginal Delivery: A Prospective Cohort Study.

Postpartum hemorrhage (PPH) is one of the leading causes of maternal morbidity worldwide. This study aimed to develop and validate a predictive model for PPH after vaginal deliveries, based on routinely available clinical and biological data. The derivation monocentric cohort included pregnant women with vaginal delivery at Brest University Hospital (France) between April 2013 and May 2015.

Clinical risk factors for vasculo-placental disorders: results from a prospective case-control study nested in HEMOTHEPP French cohort study.

Objective: Determine clinical risk factors for vasculo-placental disorders in singleton pregnancies.

Design: Prospective case-control study nested in HEMOTHEPP French cohort.

Setting: Women delivered between June, 2015 and January, 2019 in any maternity ward of Finistère.

Excessive gestational weight gain is an independent risk factor for gestational diabetes mellitus in singleton pregnancies: Results from a French cohort study.

Objective: Increase in prevalence of maternal obesity worldwide raises concern among health professionals. Our purpose was to evaluate the impact of maternal obesity and of excessive gestational weight gain (GWG) on the course of singleton pregnancies in a French maternity ward.

Study Design: 3599 consecutive women who delivered from April 2013 to May 2015 at Brest University Hospital were included in HPP-IPF cohort study, a study designed to evaluate clinical and biological determinants of postpartum hemorrhage (PPH).

Validation of the French translation of a self-administered questionnaire looking for a history of pre-eclampsia.

We evaluated the diagnostic performances of the French translation of a self-administered questionnaire designed by Diehl et al. looking for a history of pre-eclampsia. After a phone call, 206 women who gave birth at Brest University Hospital responded to the questionnaire online.

Effect of neuromuscular electrical stimulation on exercise capacity in patients with severe chronic obstructive pulmonary disease: A randomised controlled trial.

Objective: To compare strengthening by neuromuscular electrical stimulation versus cycle ergometer training during a pulmonary rehabilitation program, in patients with severe to very severe chronic obstructive pulmonary disease.

Design: A prospective randomized controlled study.

Setting: Two inpatient pulmonary rehabilitation centers.

Effectiveness of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers on total and cardiovascular mortality and morbidity in primary prevention: A nationwide study based on French Health Insurance Data (SNDS).

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) both inhibit the renin-angiotensin system (RAS) but have different sites of action. Whether clinically meaningful differences exist is still debated. The authors set up a population-based nationwide retrospective cohort study with at least 5 years of follow-up based on the comprehensive French Health Insurance Database linked to the French hospital discharge database.

Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial.

Introduction: The aim of our study was to compare clear liquid diet with 2 different polyethylene glycol (PEG)-based bowel preparation methods regarding diagnostic yield of small bowel capsule endoscopy (SBCE) in patients with suspected small bowel bleeding (SBB).

Methods: In this prospective multicenter randomized controlled trial, consecutive patients undergoing SBCE for suspected SBB between September 2010 and February 2016 were considered. Patients were randomly assigned to standard regimen, that is, clear fluids only (prep 1), standard regimen plus 500 mL PEG after SBCE ingestion (prep 2), or standard regimen plus 2 L PEG plus 500 mL PEG after SBCE ingestion (prep 3).

Safety and pharmacokinetics of Roscovitine (Seliciclib) in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa, a randomized, placebo-controlled study.

Background: The orally available kinase inhibitor R-roscovitine has undergone clinical trials against various cancers and is currently under clinical evaluation against Cushing disease and rheumatoid arthritis. Roscovitine displays biological properties suggesting potential benefits in CF: it partially corrects F508del-CFTR trafficking, stimulates the bactericidal properties of CF alveolar macrophages, and displays anti-inflammatory properties and analgesic effects.

Methods: A phase 2 trial study (ROSCO-CF) was launched to evaluate the safety and effects of roscovitine in Pseudomonas aeruginosa infected adult CF patients carrying two CF causing mutations (at least one F508del-CFTR mutation) and harboring a FEV1 ≥40%.

Impact of recommendations on sodium valproate prescription among women with epilepsy: An interrupted time-series study.

Background: The European Medicines Agency (EMA) has developed risk minimization measures (RMMs) to reduce the use of the teratogenic drug, sodium valproate (VPA). The objective was to assess the impact of these RMMs among females with epilepsy in France.

Methods: We used data from the French National Health Insurance Database (SNDS), including 114,936 females aged under 50, with a reimbursement claim for an antiepileptic drug from January 2011 to December 2017, and identified as people with epilepsy.

Hospitalization for adverse events under abiraterone or enzalutamide exposure in real-world setting: A French population-based study on prostate cancer patients.

Aims: Safety profiles of abiraterone and enzalutamide rely mainly on Phase III clinical trials. Our objective was to estimate the incidence rate ratio (IRR) for certain adverse events leading in real life to hospitalization (atrial fibrillation, acute heart failure, ischaemic heart disease, acute kidney injury [AKI], ischaemic stroke, torsade de pointe/QT interval prolongation, hepatitis and seizure), comparing abiraterone to enzalutamide. We also set out to discuss previously identified safety signals.

Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial.

Background And Purpose: Additional therapy may improve poststroke outcomes. Self-rehabilitation is a useful means to increase rehabilitation time. Mechanized systems are usual means to extend time for motor training.

The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol.

Background: Alcohol use is a major public health challenge in France, where at the age of 17 half the young people report an episode of severe alcohol intoxication in the month preceding the survey. Numerous prevention programmes have a general objective, but in adolescence individual vulnerabilities towards addictions differ significantly with personality traits. Prevention targeting personality traits enables work on risk factors for addictive behaviours, and has shown genuine efficacy.

An observational study of anaerobic bacteria in cystic fibrosis lung using culture dependant and independent approaches.

Strict anaerobes are undeniably important residents of the cystic fibrosis (CF) lung but are still unknowns. The main objectives of this study were to describe anaerobic bacteria diversity in CF airway microbiota and to evaluate the association with lung function. An observational study was conducted during eight months.

Causes of Pruritus in Patients Treated With Immune Checkpoint Inhibitors for Melanomas or Skin Carcinomas.

Pruritus is a frequent adverse event during the use of immune checkpoint inhibitors (ICIs), with a frequency estimated to be between 11 and 47%. The underlying causes remain poorly understood. The main goal was to search for putative causes of pruritus occurring in patients treated with ICIs for melanomas and cutaneous carcinomas.