49 results match your criteria: "Clinical Investigations Center[Affiliation]"

Use of the French National Health Data System (SNDS) in pharmacoepidemiology: A systematic review in its maturation phase.

Therapie

November 2024

Réseau de recherche en épidémiologie clinique et en santé publique/French Clinical Research Infrastructure Network (RECaP F-CRIN) Inserm network, 54500 Vandoeuvre-lès-Nancy, France; Sorbonne Université, INSERM, institut Pierre-Louis d'épidémiologie et de Santé publique, AP-HP, hôpital Pitié-Salpêtrière, département de Santé publique, centre de pharmacoépidémiologie (Cephepi), CIC-1901, 75000 Paris, France.

Article Synopsis
  • The study analyzes the use of the French National Health Data System (SNDS), which provides healthcare data for nearly the entire population of France, focusing on the trends in pharmacoepidemiological research based on this data.
  • A systematic review of articles from 2012 to 2018 revealed an upward trend in published studies, with the majority focusing on drug utilization, safety, and effectiveness, and a notable concentration on medications for the nervous and cardiovascular systems.
  • The findings suggest that while the SNDS is increasingly valuable for drug safety research, there is a need for more studies involving specific populations such as children, pregnant women, and the elderly, who are usually not represented in clinical trials.
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Introduction: While antipsychotic-induced weight gain has been widely described in adults, it has yet to be better characterized in children and adolescents.

Objective: The aim of this study was to assess antipsychotic-induced weight-gain reporting in children and adolescents as compared to adults, and according to the type of antipsychotic.

Methods: The study is an observational, case-non-case study using individual case safety reports from the WHO global pharmacovigilance database VigiBase from 1 January 2000 to 2 June 2021.

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Fertility and pregnancy outcomes in women with nonclassic 21-hydroxylase deficiency.

Clin Endocrinol (Oxf)

March 2023

Department of Endocrinology and Reproductive Medicine and Centre de Référence des Maladies Endocriniennes Rares de la Croissance et du Développement, Centre de Référence des Pathologies Gynécologiques Rares, AP-HP, IE3M, Hôpital Pitié-Salpêtrière, Paris, France.

Introduction: Overall fertility and pregnancy outcomes in patients with nonclassic congenital adrenal hyperplasia (NCCAH) have been poorly studied. It has been suggested that hydrocortisone (HC) may decrease the time to conceive (TTC) and the rate of miscarriage in these patients.

Objectives: To describe fertility and pregnancy outcomes in a large cohort of NCCAH women.

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Long-Read Sequencing Identifies Novel Pathogenic Intronic Variants in Gitelman Syndrome.

J Am Soc Nephrol

February 2023

Department of Physiology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.

Article Synopsis
  • - Gitelman syndrome is a rare genetic disorder linked to mutations in the SLC12A3 gene, leading to serious electrolyte imbalances, including low potassium and magnesium levels.
  • - This study used long-read sequencing on DNA samples from suspected patients to identify a second pathogenic variant in cases where only one was previously found, significantly increasing the diagnostic yield.
  • - The findings revealed that 67% of patients had a second variant, which often led to more severe symptoms, highlighting the importance of considering intronic variants and the potential need for updated genetic testing methods in diagnosing Gitelman syndrome.
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Article Synopsis
  • This study investigated the effectiveness of tocilizumab, an IL-6 antagonist, for treating glucocorticoid-dependent polymyalgia rheumatica, a condition with limited treatment options.
  • Conducted as a double-blind, placebo-controlled trial, 101 patients participated over roughly three years, comparing the effects of tocilizumab and placebo alongside a standardized reduction of prednisone.
  • Results showed that 67.3% of participants receiving tocilizumab met the primary efficacy goal, compared to 31.4% in the placebo group, indicating a significant difference in disease activity reduction.
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Background: The three main cardiac amyloidosis (CA) types have different progression and prognosis. Little is known about the mode of death (MOD) which is commonly attributed to cardiovascular causes in CA. Improving MOD's knowledge could allow to adapt patient care.

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The challenge of targets and drug discovery using large-scale screening approaches in onco-hematology.

Therapie

April 2022

Inserm CIC1427, Clinical Investigations Center, hôpital Saint-Louis, université de Paris, AP-HP, 75010 Paris, France; Inserm UMR 1131, Saint-Louis Research Institute, 75010 Paris, France. Electronic address:

Target identification and drug discovery roads have been widely improved over the past decades in onco-hematology. In this review, we summarize recent improvements in the use of physio-pathologically relevant models and innovative screening approaches to accelerate efficient drug development. Using acute myeloid leukemia as an example, we also discuss the main encountered pitfalls and propose alternative roads to improve the drug discovery journey in onco-hematology.

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Background And Objectives: Rituximab is an anti-CD20 monoclonal antibody approved in several diseases, including chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), rheumatoid arthritis (RA), and anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). The influence of underlying disease on rituximab pharmacokinetics has never been investigated for several cancer and non-cancer diseases simultaneously. This study aimed at assessing this influence using an integrated semi-mechanistic model accounting for target-mediated elimination of rituximab.

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Objective: Closed-loop insulin systems represent a technological advance in diabetes management but have rarely been studied in pregnancy. We report a case of a patient with type 1 diabetes mellitus who was previously a user of the Paradigm VEO pump and then migrated to Medtronic 670G. .

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Background: Sensitized patients, i.e. recipients with preformed donor-specific HLA antibodies (pfDSA), are at high-risk of developing antibody-mediated rejections (AMR) and dying after heart transplantation (HTx).

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COVID-19 vaccines and myocarditis.

Arch Cardiovasc Dis

August 2021

Sorbonne Université, Clinical Investigations Center Paris-Est, Hôpital Universitaire Pitié-Salpêtrière, AP-HP, INSERM, 75013 Paris, France.

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Article Synopsis
  • This study examined the clinical progression and treatment factors of classic/endemic Kaposi's Sarcoma (KS) by analyzing 160 patients diagnosed between 1990 and 2013.
  • It found that 41.2% of these patients required systemic treatment (ST), with key risk factors for ST initiation including long time to diagnosis, type of KS, and lesion characteristics.
  • Additionally, there was no significant difference in efficacy between treatment types, suggesting treatment decisions can be made based on the patient's overall health instead of specific medication effectiveness.
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In patients with allogenic hematopoietic stem cell transplantation (allo-HSCT), immune-checkpoint inhibitors (ICI) are used to treat malignancy recurrence. However, ICI are also associated with graft vs. host disease (GVHD).

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Article Synopsis
  • Tocilizumab, an anti-interleukin-6 receptor treatment, showed potential benefits for severe COVID-19 pneumonia when given timely as a single 400 mg dose.
  • In a study of 246 patients, those treated with tocilizumab had significantly better outcomes compared to those who did not receive the medication, with a lower rate of mortality and ventilatory support needed.
  • The results indicated that tocilizumab could improve survival without the need for mechanical ventilation, making it a promising option for severe COVID-19 patients.
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Aims: Prevalence of the use of antipsychotics (APs) in the paediatric population is globally increasing. The aim of this study was to describe multinational trends and patterns in AP use in children and adolescents in Europe.

Methods: This was a dynamic retrospective cohort study comprising all children and adolescents (⩽18 years of age).

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Use of Negative Pressure Wound Therapy in Surgical Site Infection During Pregnancy: A Case Study.

J Wound Ostomy Continence Nurs

March 2020

María Fernanda Escobar-Vidarte, MD, MSc, Department of Gynecology and Obstetrics, Fundación Clínica Valle Del Lili, Cali, Colombia. Adriana Messa, MD, Department of Gynecology and Obstetrics, Fundación Clínica Valle Del Lili, Cali, Colombia. Albaro Jose Nieto, MD, Department of Gynecology and Obstetrics, Fundación Clínica Valle Del Lili, Cali, Colombia. Maria Paula Echavarría, MD, Department of Gynecology and Obstetrics, Fundación Clínica Valle Del Lili, Cali, Colombia. Javier Andres Carvajal, MD, Department of Gynecology and Obstetrics, Fundación Clínica Valle Del Lili, Cali, Colombia. Paula Andrea Fernández, MD, Clinical Investigations Center, Fundación Clinica Valle del Lili, Cali, Colombia.

Background: Surgical site infections (SSIs) are a known cause of morbidity and mortality; however, evidence related to management of SSIs during pregnancy is sparse.

Case: A 26-year-old female patient with an adnexal cystic lesion underwent laparotomy at 19 weeks of pregnancy. She experienced a late SSI 10 days after initial surgery, necessitating surgical debridement.

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Background: Gitelman syndrome is a salt-losing tubulopathy caused by mutations in the gene, which encodes the thiazide-sensitive sodium-chloride cotransporter. Previous studies suggested an intermediate phenotype for heterozygous carriers.

Methods: To evaluate the phenotype of heterozygous carriers of pathogenic mutations, we performed a cross-sectional study of patients with Gitelman syndrome, heterozygous carriers, and healthy noncarriers.

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Objective: To assess MRI features for the diagnosis of small hepatocellular carcinomas (HCCs) and especially for nodules not showing both of the typical hallmarks.

Patients And Methods: Three hundred and sixty-four cirrhotic patients underwent liver MRI for 10-30 mm nodules suggestive of HCC. The diagnostic performances of MRI features [T1, T2; diffusion-weighted (DW) imaging signal, enhancement, capsule, fat content] were tested, both individually and in association with both typical hallmarks and as substitutions for one hallmark.

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