Alexandra Jobert
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View article: Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO)
Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO) Open
View article: Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO)
Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO) Open
Background Atopic dermatitis (AD) is a prevalent chronic relapsing inflammatory skin disease affecting individuals across the lifespan from childhood through adulthood. The burden of AD is now well recognized. Recent advancements in unders…
View article: Evaluation of pelvic floor rehabilitation in the prevention of low anterior resection syndrome: Study protocol of the <scp>CONTICARE</scp> trial
Evaluation of pelvic floor rehabilitation in the prevention of low anterior resection syndrome: Study protocol of the <span>CONTICARE</span> trial Open
Aim Bowel dysfunction following sphincter‐preserving rectal resection for cancer, commonly referred to as low anterior resection syndrome (LARS), significantly impacts patients' quality of life. Preventing this condition is essential for h…
View article: Public health importance of the detection of high-grade dysplasia and adenocarcinoma lesions following 2 different protocols: High resolution Virtual chromoendoscopy versus Seattle protocol: CONVERSE study
Public health importance of the detection of high-grade dysplasia and adenocarcinoma lesions following 2 different protocols: High resolution Virtual chromoendoscopy versus Seattle protocol: CONVERSE study Open
Background: Barrett's esophagus (BE) is a pre-cancerous condition with an increased risk of esophageal adenocarcinoma (EAC). Current surveillance involves white light endoscopy with random biopsies (Seattle Protocol, SP) but has limitation…
View article: Pros and cons of internal limiting membrane peeling during epiretinal membrane surgery: a randomised clinical trial with microperimetry (PEELING)
Pros and cons of internal limiting membrane peeling during epiretinal membrane surgery: a randomised clinical trial with microperimetry (PEELING) Open
Background After idiopathic epiretinal membrane (iERM) removal, it is unclear whether the internal limiting membrane (ILM) should be removed. The objective was to assess if active ILM peeling after iERM removal could induce microscotomas. …
View article: Daratumumab, carfilzomib, lenalidomide, and dexamethasone with tandem transplant for high-risk newly diagnosed myeloma
Daratumumab, carfilzomib, lenalidomide, and dexamethasone with tandem transplant for high-risk newly diagnosed myeloma Open
High-risk (HR) cytogenetics are associated with poor outcomes in newly diagnosed multiple myeloma (NDMM), and dedicated studies should address this difficult-to-treat population. The phase 2 study 2018-04 from the Intergroupe Francophone d…
View article: Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial
Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial Open
Background We evaluated the safety and efficacy of XAV-19, an antispike glyco-humanized swine polyclonal neutralizing antibody in patients hospitalized with severe coronavirus disease 2019 (COVID-19). Methods This phase 2b clinical trial e…
View article: Interferon gamma-1b for the prevention of hospital-acquired pneumonia in critically ill patients: a phase 2, placebo-controlled randomized clinical trial
Interferon gamma-1b for the prevention of hospital-acquired pneumonia in critically ill patients: a phase 2, placebo-controlled randomized clinical trial Open
Among mechanically ventilated patients with acute organ failure, treatment with interferon gamma-1b compared with placebo did not significantly reduce the incidence of hospital-acquired pneumonia or death on day 28. Furthermore, the trial …
View article: Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients at Risk of Aspiration
Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients at Risk of Aspiration Open
Importance It is uncertain whether a rapid-onset opioid is noninferior to a rapid-onset neuromuscular blocker during rapid sequence intubation when used in conjunction with a hypnotic agent. Objective To determine whether remifentanil is n…
View article: Analyse de la place des études de phase IV pour l'évaluation du risque médicamenteux dans les populations vulnérables
Analyse de la place des études de phase IV pour l'évaluation du risque médicamenteux dans les populations vulnérables Open
During clinical development, the risk to the patient is monitored. However, when a health product is placed on the market, knowledge of its benefit-risk balance is only fragmentary. The post-marketing surveillance system, which makes it po…
View article: Raltegravir 1200 mg once daily as maintenance therapy in virologically suppressed HIV-1 infected adults: QDISS open-label trial
Raltegravir 1200 mg once daily as maintenance therapy in virologically suppressed HIV-1 infected adults: QDISS open-label trial Open
View article: Regulatory Framework Implementation for the Prescription of Zolpidem in France, What Impact in the Older People?
Regulatory Framework Implementation for the Prescription of Zolpidem in France, What Impact in the Older People? Open
Background: Zolpidem is one of the most prescribed hypnotic drugs. In 2001, the World Health Organization alerted a risk of pharmacodependence associated with zolpidem. The French health authority decided in 2017 to enforce security on the…
View article: Corrigendum to ‘Editor's Choice – A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial’ [EJVES 61/3 (2021) 447–455]’
Corrigendum to ‘Editor's Choice – A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial’ [EJVES 61/3 (2021) 447–455]’ Open
View article: Raltegravir 1200 mg Once Daily as Maintenance Therapy in Virologically Suppressed HIV-1 Infected Adults : QDISS Open-Label Trial
Raltegravir 1200 mg Once Daily as Maintenance Therapy in Virologically Suppressed HIV-1 Infected Adults : QDISS Open-Label Trial Open
Background: Raltegravir (RAL) has favorable tolerability and safety profile, with few and manageable drug interactions. The use of RAL 1200 mg once daily (qd) for first-line therapy is well established. We assessed efficacy and safety of R…
View article: Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study
Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study Open
We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in coronavirus disease 2019 (COVID-19)-related moderate pneumonia. The…
View article: Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial
Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial Open
Objective To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery. Design Phase III, randomised, double blind, placebo controlled trial. Setting 34 centres in France, December 2017 to M…
View article: Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study
Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study Open
Background We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. In vitro, 100% neutralization activity is seen with XAV-19 concentrat…
View article: Assessment of remifentanil for rapid sequence induction and intubation in patients at risk of pulmonary aspiration of gastric contents compared to rapid-onset paralytic agents: study protocol for a non-inferiority simple blind randomized controlled trial (the REMICRUSH study)
Assessment of remifentanil for rapid sequence induction and intubation in patients at risk of pulmonary aspiration of gastric contents compared to rapid-onset paralytic agents: study protocol for a non-inferiority simple blind randomized controlled trial (the REMICRUSH study) Open
View article: Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial
Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial Open
Background Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing …
View article: Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial
Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial Open
Background: The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from matrix metalloproteinases. It is possible their chelating activity may help inhibit COVID-19 infection by limitin…
View article: Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial
Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial Open
Background : The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from matrix metalloproteinases. It is possible their chelating activity may help inhibit COVID-19 infection by limiti…
View article: Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial
Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial Open
Background : The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from matrix metalloproteinases. It is possible their chelating activity may help inhibit COVID-19 infection by limiti…
View article: Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial Open
View article: Impact of Doxycycline on Covid-19 Patients With Risk Factors of Disease Degradation: Dynamic, A Randomised Controlled Double-blind Trial
Impact of Doxycycline on Covid-19 Patients With Risk Factors of Disease Degradation: Dynamic, A Randomised Controlled Double-blind Trial Open
Background: The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from metalloproteases (MMPs). It is possible that their chelating activity may help to inhibit COVID-19 infection by l…
View article: Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial Open
Background: Almost 15 % of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will e…
View article: Do older people know why they take benzodiazepines? A national French cross‐sectional survey of long‐term consumers
Do older people know why they take benzodiazepines? A national French cross‐sectional survey of long‐term consumers Open
Objectives Benzodiazepines and non‐benzodiazepine hypnotics (or Z‐drugs) (BZD/Z) are widely prescribed for older patients despite major side effects and risks when chronically used. The patient's understanding of the treatment is one of th…
View article: Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial Open
- Background: Almost 15 % of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will…
View article: Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial
Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial Open
View article: Dexamethasone for Patients Undergoing Major Noncardiac Surgery: A Multicenter, Double-Blind, Controlled Randomized Trial
Dexamethasone for Patients Undergoing Major Noncardiac Surgery: A Multicenter, Double-Blind, Controlled Randomized Trial Open
View article: Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years – The PreKit-QoL study protocol
Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years – The PreKit-QoL study protocol Open