80 results match your criteria: "Clinical Pharmacology and Clinical Research[Affiliation]"

Background: Miscarriage is a frequent problem that requires dilation and curettage in 30% of cases. This routine surgery may lead to intrauterine adhesions and severe infertility. Hyaluronic acid gel is known to reduce intrauterine adhesions after hysteroscopic surgery.

View Article and Find Full Text PDF
Article Synopsis
  • - The study aimed to compare the immune responses of two mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) to see if mixing them for the second dose produces a similar immune effect as receiving the same vaccine for both doses.
  • - Nearly 400 adults participated, receiving either the same vaccine for both doses or a mix; the results showed that mixing the vaccines resulted in different antibody levels.
  • - Overall, the research suggests that using either vaccine interchangeably is safe and effective, but those who received mRNA-1273 as a second dose reported more side effects compared to those who got BNT162b2.
View Article and Find Full Text PDF

Balance of benefit and risk of ticagrelor in patients with diabetes and stable coronary artery disease according to bleeding risk assessment with the CRUSADE score: Data from THEMIS and THEMIS PCI.

Am Heart J

July 2022

Université de Paris, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France; Imperial College, Royal Brompton Hospital, London, UK. Electronic address:

Background: The THEMIS trial demonstrated that in high-risk patients with stable coronary artery disease and diabetes without previous myocardial infarction or stroke, ticagrelor, in addition to aspirin, reduced the incidence of ischemic events but increased major bleeding. Identification of patients who could derive the greatest net benefit from the addition of ticagrelor appears important. We used the CRUSADE bleeding risk score to risk stratify the THEMIS population.

View Article and Find Full Text PDF

Deleterious synergistic effects of acute heart failure and diabetes mellitus in patients with acute coronary syndrome: Data from the FAST-MI Registries.

Arch Cardiovasc Dis

May 2022

Department of Cardiology, INSERM U-970, European Hospital of Georges-Pompidou, Assistance publique-Hôpitaux de Paris, Université de Paris, 75015 Paris, France. Electronic address:

Background: Diabetes mellitus (DM) predisposes patients to acute myocardial infarction (AMI) and acute heart failure (AHF).

Aims: To assess correlates of AHF occurring at the early stage of AMI and synergism between early AHF and DM on 5-year mortality.

Methods: FAST-MI 2005 and 2010 included 7839 consecutive patients admitted for AMI.

View Article and Find Full Text PDF

Comparison of Patients Infected With Delta Versus Omicron COVID-19 Variants Presenting to Paris Emergency Departments : A Retrospective Cohort Study.

Ann Intern Med

June 2022

Sorbonne Université, UMR Inserm 1166, IHU ICAN, and Emergency Department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, Paris, France (B.R., Y.F.).

Background: At the end of 2021, the B.1.1.

View Article and Find Full Text PDF

Impact of an intensive multimodal educative program on behavioral disorders of polyhandicapped patients: A randomized controlled trial.

Arch Pediatr

May 2022

Hôpital de La Roche Guyon, Service de Polyhandicap Pédiatrique, Assistance Publique Hôpitaux de Paris, 1 Rue Justinien Blazy, 95780 La Roche-Guyon, France; Sorbonne Université, UPMC, GRC ConCer-LD and AP-HP, Hôpital Trousseau, Service de Neuropédiatrie - Pathologie du développement, Paris, France, Centre de référence des déficits intellectuels de causes rares, Inserm U 1141, 26 Avenue du Dr Arnold Netter, 75012 Paris, France.

Background: Hospitalized children and young adults with polyhandicap (PLH) often present with behavioral and relational disorders that are mainly related to their difficulties in communicating and interacting with their environments. Educational support is rarely provided to these patients. An intensive multimodal educative program could help in reducing behavioral disorders and in improving the quality of life of healthcare workers, including nurses and auxiliary nurses.

View Article and Find Full Text PDF

One-Year Major Cardiovascular Events After Restrictive Versus Liberal Blood Transfusion Strategy in Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Trial.

Circulation

February 2022

Department of Clinical Pharmacology-Clinical Research Platform (Unite de Recherche Clinique de l'est parisien-Centre de ressource biologique-Centre de Recherche Clinique), AP-HP.SU, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials, Sorbonne-Université, Paris (T.S.).

View Article and Find Full Text PDF

The clinical benefits to be expected from intraoperative nociception monitors are currently under investigation. Among these devices, the Analgesia Nociception-Index (ANI) has shown promising results under sevoflurane anesthesia. Our study investigated ANI-guided remifentanil administration under propofol anesthesia.

View Article and Find Full Text PDF

Objective: Atrial fibrillation (AF) and myocardial infarction (MI) are commonly comorbid and associated with adverse outcomes. Little is known about the impact of AF on quality of life and outcomes post-MI. We compared characteristics, quality of life and clinical outcomes in stable patients post-MI with/without AF.

View Article and Find Full Text PDF
Article Synopsis
  • The study aimed to validate the safety of a combined diagnostic strategy for ruling out pulmonary embolism (PE) that incorporates the YEARS rule and age-adjusted D-dimer thresholds in emergency departments across France and Spain.
  • It involved a total of 1414 patients who were either at low risk for PE or had an intermediate risk, examining the outcomes of using different intervention strategies regarding chest imaging and D-dimer levels.
  • The results showed that the intervention group had a very low rate of venous thromboembolism at 3 months (0.15%), suggesting that this combined strategy is a safe alternative for excluding PE without unnecessary imaging.
View Article and Find Full Text PDF

Purpose: After the 2 years of follow-up, we aimed to evaluate at 5 years the impact of human papillomavirus (HPV) status, tobacco, and initial treatment approach on progression-free survival (PFS) and overall survival (OS) of patients with oropharyngeal cancer (OPC) in France.

Methods: Papillophar study was designed as a prospective cohort of 340 OPC patients in 14 French hospitals. HPV-positive status (21.

View Article and Find Full Text PDF
Article Synopsis
  • The study investigates the effectiveness and safety of cyclophosphamide for treating patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) when used alongside high-dose methylprednisolone.
  • Conducted as a double-blind, placebo-controlled trial across 35 departments in France, 120 patients were randomly assigned to receive either cyclophosphamide or a placebo, with all participants monitored for 3-month all-cause mortality.
  • Results showed that 3-month mortality was 45% in the cyclophosphamide group compared to 31% in the placebo group, indicating no significant advantage for cyclophosphamide (p=0.10), and the trial is registered as NCT024605
View Article and Find Full Text PDF

Atherosclerotic cardiovascular disease causes heart attacks and strokes, which are the leading causes of mortality worldwide. The formation of atherosclerotic plaques is initiated when low-density lipoproteins bind to heparan-sulfate proteoglycans (HSPGs) and become trapped in the subendothelial space of large and medium size arteries, which leads to chronic inflammation and remodelling of the artery wall. A proliferation-inducing ligand (APRIL) is a cytokine that binds to HSPGs, but the physiology of this interaction is largely unknown.

View Article and Find Full Text PDF

Ending Gender Inequality in Cardiovascular Clinical Trial Leadership: JACC Review Topic of the Week.

J Am Coll Cardiol

June 2021

Michael E. DeBakey Veterans Affairs Medical Center and Winters Center for Heart Failure Research, Cardiovascular Institute, Cardiology, Baylor College of Medicine, Houston, Texas, USA.

Women are under-represented as leaders of cardiovascular randomized controlled trials, representing 1 in 10 lead authors of cardiovascular trials published in high-impact journals. Although the proportion of cardiovascular specialists who are women has increased in recent years, the proportion of cardiovascular clinical trialists who are women has not. This gap, underpinned by systemic sexism, has not been adequately addressed.

View Article and Find Full Text PDF

Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance.

BMJ Open Respir Res

June 2021

Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URC-CRC-CRB), Hôpital St Antoine, Paris, France, Assistance Publique-Hôpitaux de Paris (AP-HP), Sorbonne Université, Paris, France.

Background: Whereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.

Research Question: To assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.

Study Design And Methods: This multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset <72 hours, 100-200 mL estimated bleeding amount), related to a systemic arterial mechanism.

View Article and Find Full Text PDF

Dietary supplementation is commonly used in men with male infertility but its exact role is poorly understood. The aim of this multicenter, randomized, double-blind, placebo-controlled trial was to evaluate the impact of high-dose folic acid supplementation on IVF-ICSI outcomes. 162 couples with male infertility and an indication for IVF-ICSI were included for one IVF-ICSI cycle.

View Article and Find Full Text PDF

Acute myocardial infarction is a common condition responsible for heart failure and sudden death. Here, we show that following acute myocardial infarction in mice, CD8 T lymphocytes are recruited and activated in the ischemic heart tissue and release Granzyme B, leading to cardiomyocyte apoptosis, adverse ventricular remodeling and deterioration of myocardial function. Depletion of CD8 T lymphocytes decreases apoptosis within the ischemic myocardium, hampers inflammatory response, limits myocardial injury and improves heart function.

View Article and Find Full Text PDF

Importance: The optimal transfusion strategy in patients with acute myocardial infarction and anemia is unclear.

Objective: To determine whether a restrictive transfusion strategy would be clinically noninferior to a liberal strategy.

Design, Setting, And Participants: Open-label, noninferiority, randomized trial conducted in 35 hospitals in France and Spain including 668 patients with myocardial infarction and hemoglobin level between 7 and 10 g/dL.

View Article and Find Full Text PDF

Beware of simple explanations.

Heart

March 2021

Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, and Université de Paris, Paris, France.

View Article and Find Full Text PDF

Background: Diabetes mellitus (DM) is associated with increased cardiovascular (CV) risk. We compared health-related quality of life (HRQoL), healthcare resource utilization (HRU), and clinical outcomes of stable post-myocardial infarction (MI) patients with and without DM.

Hypothesis: In post-MI patients, DM is associated with worse HRQoL, increased HRU, and worse clinical outcomes.

View Article and Find Full Text PDF

Polymorphisms and Clopidogrel Efficacy and Safety in Patients With Minor Stroke or TIA.

Neurology

January 2021

From the Department of Neurology (Y.P., H.L., Y.W., X.M., J.L., X.Z., L.L., Y.W.), Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases (Y.P., H.L., Y.W., X.M., J.L., X.Z., L.L., Y.W.), Beijing, China; Department of Neurology (R.W.), Duke University Medical Center, Durham, NC; Dell Medical School (S.C.J.), University of Texas at Austin; Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB) (T.S.), Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine (APHP.SU); Sorbonne Université (T.S.); FACT (French Alliance for Cardiovascular Clinical Trials) (T.S.), Paris, France; and Department of Neurology (D.W.), Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, AZ.

Objective: To investigate the association between protease-activated receptor-1 (PAR-1) gene polymorphisms and efficacy of clopidogrel for minor stroke or TIA.

Methods: Three single nucleotide polymorphisms ( [681G>A, rs4244285], * [636G>A, rs4986893], and [IVSn-14 A/T, rs168753]) were genotyped among 2,924 patients randomized to clopidogrel plus aspirin (n = 1,461) or aspirin alone (n = 1,463). The primary efficacy outcome was new stroke (ischemic or hemorrhagic) and the safety outcome was any bleeding.

View Article and Find Full Text PDF

Introduction: In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis and no hemoptysis and in whom PE is not the most likely diagnosis. However, this decision rule has never been prospectively compared to the usual strategy. Furthermore, it is unclear if the YEARS rule can be used on top of the Pulmonary Embolism Rule-out Criteria (PERC).

View Article and Find Full Text PDF

Aims: Few studies describe recent changes in the prevalence, management, and outcomes of cardiogenic shock (CS) patients complicating acute myocardial infarction (AMI) in the era of widespread use of invasive strategies. The aim of the present study was to analyse trends observed in CS complicating AMI over the past 10 years, focusing on the timing of CS occurrence (i.e.

View Article and Find Full Text PDF

Background: Evidence is lacking on long-term outcomes in unselected patients surviving the first year following myocardial infarction (MI).

Methods And Results: The TIGRIS (long-Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients) prospective registry enrolled 9176 eligible patients aged ≥50 years, 1-3 years post-MI, from 25 countries. All had ≥1 risk factor: age ≥ 65 years, diabetes mellitus, second prior MI, multivessel coronary artery disease, chronic kidney disease (CKD).

View Article and Find Full Text PDF