76 results match your criteria: "Caen-Normandy University[Affiliation]"

Compensating patients in trials: Perspectives from an ethical committee versus sponsor.

Eur J Clin Invest

October 2023

Pharmacovigilant, Responsable de lunite de vigilance des essais cliniques (UVEC), Direction de la Recherche et de l'innovation, CHU Caen Normandie, Caen, France.

Background: According to European clinical research legislation, no undue influence, including financial incentives, should be used to encourage participation in clinical trials. Financial compensation should be based on the inconvenience experienced by patients and is determined by the sponsor.

Objectives: The objective of this study was to assess the adequacy of patients' financial compensation by obtaining an external ethical opinion compared to the actual compensation provided.

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Ocean acidification and warming are key stressors for many marine organisms. Some organisms display physiological acclimatization or plasticity, but this may vary across species ranges, especially if populations are adapted to local climatic conditions. Understanding how acclimatization potential varies among populations is therefore important in predicting species responses to climate change.

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Cutaneous manifestations induced by check point inhibitors in 120 melanoma patients-The European MelSkinTox study.

J Eur Acad Dermatol Venereol

April 2023

Nantes Université, Nantes - Angers INSERM, Immunology and New Concepts in ImmunoTherapy, INCIT, UMR 1302, Nantes, France.

Background: Checkpoint inhibitors provide an effective approach for the melanoma treatment. They prolong lymphocyte effects, which explains the cytotoxicity underlying immune-related adverse events (IrAEs). Cutaneous IrAEs affect nearly 40% of PD-1i and 50% of CTLA4i-treated patients.

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Introduction: Hypertension is associated with significant cardio-vascular morbi-mortality. However, hypertension control is low, especially in France. The reasons influencing general practitioners' (GPs) prescription of antihypertensive drugs (ADs) remains unclear.

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Background: Cemiplimab is a monoclonal antibody targeting the PD-1, and phase II trials have shown its efficacy in the treatment of advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or radiation therapy as a first- or later-line treatment. A synergistic antitumoral response has been demonstrated with concurrent radiotherapy and PD1-immunotherapy. However, no real-life study has demonstrated this effect in advanced cutaneous squamous cell carcinoma.

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Background: The anatomic site for central venous catheter insertion influences the risk of central venous catheter-related intravascular complications. We developed and validated a predictive score of required catheter dwell time to identify critically ill patients at higher risk of intravascular complications.

Methods: We retrospectively conducted a cohort study from three multicenter randomized controlled trials enrolling consecutive patients requiring central venous catheterization.

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Consequences of General Anesthesia in Infancy on Behavior and Brain Structure.

Anesth Analg

February 2023

From the Normandie Universite UNICAEN, INSERM, GIP Cyceron, Institut Blood and Brain @Caen-Normandie, Physiopathology and Imaging of Neurological Disorders, Caen, France.

Background: One in 7 children will need general anesthesia (GA) before the age of 3. Brain toxicity of anesthetics is controversial. Our objective was to clarify whether exposure of GA to the developing brain could lead to lasting behavioral and structural brain changes.

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Background: Healthcare curricula need summative assessments relevant to and representative of clinical situations to best select and train learners. Simulation provides multiple benefits with a growing literature base proving its utility for training in a formative context. Advancing to the next step, "the use of simulation for summative assessment" requires rigorous and evidence-based development because any summative assessment is high stakes for participants, trainers, and programs.

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Insomnia disorder has been associated with poor executive functioning. Functional imaging studies of executive functioning in insomnia are scarce and inconclusive. Because the Attentional Network Test relies on well-defined cortical networks and sensitively distinguishes different aspects of executive function, it might reveal brain functional alterations in relatively small samples of patients.

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Article Synopsis
  • Myocardial inflammation is linked to genetic arrhythmogenic cardiomyopathy (ACM), suggesting that recurrent acute myocarditis (RAM) might indicate early stages of ACM.
  • A study examined 21 patients with RAM over an average follow-up of 3.3 years, finding that 67% exhibited ACM phenotypes, and genetic testing revealed mutations in over half of those tested.
  • The findings suggest that RAM could represent early inflammatory phases of ACM, and recognizing RAM in diagnostic criteria might facilitate earlier diagnosis and treatment.
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: The urgency of having fair and trustworthy competency-based assessment in medical training is growing. Simulation is increasingly recognized as a potent method for building and assessing applied competencies. The growing use of simulation and its application in summative assessment calls for comprehensive and rigorously designed programs.

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Background: Breast cancer is the leading cancer in women in France both in incidence and mortality. Organized breast cancer screening (OBCS) has been implemented nationwide since 2004, but the participation rate remains low (48%) and inequalities in participation have been reported. Facilities such as mobile mammography units could be effective to increase participation in OBCS and reduce inequalities, especially areas underserved in screening.

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Background: The majority of central venous catheters (CVC) removed in the ICU are not colonized, including when a catheter-related infection (CRI) is suspected. We developed and validated a predictive score to reduce unnecessary CVC removal.

Methods: We conducted a retrospective cohort study from five multicenter randomized controlled trials with systematic catheter-tip culture of consecutive CVCs.

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Background: Advanced mycosis fungoides (MF) and Sézary syndrome (SS) are rare, aggressive cutaneous T-cell lymphomas that may be difficult to treat. Mogamulizumab is a recent monoclonal antibody targeting the CCR4 receptor expressed on the surface of Sézary cells. It can be prescribed in MF/SS stages III to IV in the second line after systemic therapy or in stages IB-II after two unsuccessful systemic therapies.

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Definition, general principles and expected benefits of enhanced recovery in surgery.

J Gynecol Obstet Hum Reprod

June 2022

AP-HP, Hôpital Européen Georges-Pompidou, Gynecological oncological surgery unit, F-75015 Paris, France.

A multimodal approach to promoting recovery from surgery was first described by Henrik Kehlet in 1995. This approach has since been significantly developed and refined, and is now referred to as Enhanced Recovery in Surgery (ERS). The goal of ERS is to enable a patient to regain his/her pre-surgery physical and psychological state after a surgical procedure - notably by reducing the stress and the inflammatory response inevitably triggered by surgery.

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To what extent is enhanced recovery in surgery used in French obstetrics and gynecology departments?

J Gynecol Obstet Hum Reprod

May 2022

Ambulatory Surgery Department, Paris Descartes University, Cochin Hospital, 27 Rue du Faubourg Saint-Jacques, F-75014 Paris, France.

The objective of the present study was to evaluate the implementation of Enhanced Recovery in Surgery (ERS) in French obstetrics and gynecology departments. To achieve this objective, we drafted an online questionnaire about ERS protocols for cesarian sections and hysterectomies with a benign indication and put a hyperlink on the 'French National College of Gynecologists and Obstetricians' (Collège National des Gynécologues et Obstétriciens Français) website. We obtained 112 analyzable responses.

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Perioperative parameters to consider for enhanced recovery in surgery (ERS) in gynecology (excluding breast surgery).

J Gynecol Obstet Hum Reprod

May 2022

Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, service de chirurgie et oncologie gynécologique et mammaire, F-75013, Paris, France; Sorbonne université, biologie et thérapeutique du cancer, centre de recherche Saint-Antoine (CRSA), Paris, France.

The current review explores the Enhanced Rehabilitation in Surgery (ERS) approach in the specific context of gynecological surgery. Implementation of an ERS protocol in gynecological surgery reduces postoperative complications and length of stay without increasing morbidity. An ERS approach is based on maintaining an adequate diet and hydration before the operation, according to the recommended time frame, to reduce the phenomenon of insulin resistance, and to optimize patient comfort.

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Background: The coronavirus pandemic continues to shake the embedded structures of traditional in-person education across all learning levels and across the globe. In healthcare simulation, the pandemic tested the innovative and technological capabilities of simulation programs, educators, operations staff, and administration. This study aimed to answer the question: What is the state of distance simulation practice in 2021?

Methods: This was an IRB-approved, 34-item open survey for any profession involved in healthcare simulation disseminated widely and internationally in seven languages from January 14, 2021, to March 3, 2021.

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General or regional anaesthesia can be used for chronic subdural haematoma evacuation, but no study has compared these types of anaesthesia in terms of peri-operative outcomes. This single-centre, prospective, randomised study included adult patients (age ≥ 18 years) undergoing surgical chronic subdural haematoma evacuation. Patients were randomly allocated to general (target-controlled total intravenous anaesthesia with propofol and remifentanil) or regional anaesthesia (bilateral scalp block with remifentanil sedation if required).

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Knee and hip osteoarthritis (KHOA) are a source of functional impairment. With aging, the management of osteoarthritis (OA) is a major issue in the search for improved quality of life. Spa treatment provides short- and mid-term symptom relief without serious side effects.

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Background: Competency-based medical education (CBME) has revolutionized approaches to training by making expectations more concrete, visible, and relevant for trainees. Designing, applying, and updating CBME requirements challenges residency programs, which must address many aspects of training simultaneously. This challenge also exists for educational regulatory bodies in creating and adjusting national competencies to standardize training expectations.

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Mutations in (vitamin D 24-hydroxylase) and (renal phosphate transporter NPT2a) cause autosomal recessive Infantile Hypercalcemia type 1 and 2, illustrating links between vitamin D and phosphate metabolism. Patients may present with hypercalciuria and alternate between chronic phases with normal serum calcium but inappropriately high 1,25-(OH)D and appropriately low PTH, and acute phases with hypercalcemia with suppressed PTH. Mutations in and have been associated with phosphate wasting without hypercalcemia.

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