Antiangiogenic therapies like bevacizumab, have notably improved cancer treatment, including for gynecological cancers, by inhibiting the vascular endothelial growth factor and thus limiting tumor growth. In treating advanced ovarian cancer, bevacizumab has been shown to extend progression-free survival by four months, though it also induces or worsens hypertension in 2 to 19% of patients by affecting vascular nitric oxide production or by capillary rarefaction. This hypertension may result in severe cardiovascular events, necessitating the use of antihypertensive drugs like calcium channel blockers and RAAS inhibitors (angiotensin converting enzyme - ACE - inhibitors mainly), despite some concerns about their effects on VEGF secretion and CA125 levels. Clinical guidelines vary, with some favoring ACE inhibitors while others recommend calcium channel blockers, underlining the need for comparative studies on these drugs' oncological and cardiovascular impacts. To address these issues, this study utilizes an emulated trial approach, leveraging comprehensive data from the French National Health Data System to compare the efficacy of these antihypertensive classes in reducing relapse and improving survival in ovarian cancer patients treated with bevacizumab.
The investigators will emulate a target clinical trial to compare the impact of antihypertensive treatments on outcomes of patients with bevacizumab-associated hypertension by ACE inhibitors (arm A) versus calcium channel blockers (CCBs, arm B) on the risk of ovarian cancer withdrawal after surgery.

开始日期2024-05-20

申办/合作机构

Centre Hospitalier Universitaire Pitie-Salpetriere

[+1]

NCT06450080 / RecruitingN/AIIT

Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue

Squamous cell carcinoma (SCC) could be a very aggressive cancer and has a bad prognosis if not detected early and thus is associated with high mortality. The development of simple and reliable biomarkers for the early detection of SCC is one of the solutions to better diagnose, treat these tumors, evaluate and monitor treatments, and hence reduce mortality. In a previous work, the investigators demonstrated the ability of Proton Magnetic resonance spectroscopy (1H-MRS) to non-invasively assess spectroscopic and metabolic profiles of tongue tissue in healthy subjects. In the present work, the investigators challenge the use of in-vivo 1H-MRS as a potential method for non-invasive metabolic monitoring of patients with squamous cell carcinoma of the tongue undergoing therapy. Thus the main objective is to study the spectroscopic and metabolic differences, e.g. including variation in the metabolite TMA-Cho (trimethylamine-choline), of tongue tissue between healthy subjects and in patients with squamous cell carcinoma of the tongue, before and after surgery.

开始日期2024-03-27

申办/合作机构

Centre Hospitalier Universitaire Amiens-Picardie

[+1]

NCT06199284 / RecruitingN/AIIT

Evaluation of the Safety and Efficacy of the Atalante Exoskeleton in the Rehabilitation of Patients With Amyotrophic Lateral Sclerosis

Using a MRI gait motor imagery paradigm in ALS patients in order to study how ALS affects the function of the central neural networks involved in gait function, we showed a reorganization of the motor networks that represents a compensatory response to the dysfunction of the networks involved in gait function. Our main hypothesis is that by providing coherent proprioceptive input to the sensorimotor integration areas, gait training with an exoskeleton may boost compensatory network reorganization and help to maintain function. We hypothesize that this can be achieved through a locomotion training strategy that reproduces normal gait motor patterns and appropriate sensory feedback. Gait training with an exoskeleton can meet these needs. The Atalante exoskeleton offers unique potential thanks to its cutting-edge technological features, hands-free functions and availability in numerous centers across Europe. Evaluation of its safety and efficacy in ALS is of the utmost interest in order to generalize this new approach in ALS.

开始日期2024-01-31

申办/合作机构

Centre Hospitalier Universitaire Pitie-Salpetriere

[+1]

100 项与 Centre Hospitalier Universitaire Pitie-Salpetriere 相关的临床结果

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106

项与 Centre Hospitalier Universitaire Pitie-Salpetriere 相关的文献（医药）

2020-11-01·Liver Transplantation1区 · 医学

Liver Transplantation From Controlled Donors After Circulatory Death Using Normothermic Regional Perfusion: An Initial French Experience

1区 · 医学

Article

作者: Antoine, Corinne ; Dondero, Federica ; Savier, Eric ; Jasseron, Carine

A national program of controlled donation after circulatory death (cDCD) began in France in 2014 involving the use of a standardized national protocol that involves the systematic use of normothermic regional perfusion (NRP). In this article, we describe in detail the French cDCD program. Between January 1, 2015, and December 31, 2018, 225 livers were offered for donation, resulting in 123 cDCD liver transplantations (LTs). The overall 90‐day graft survival rate was 93.1% (95% confidence interval [CI], 85.9%‐96.6%). A total of 21 of 123 LTs (17%) did not adhere strictly to the national protocol. The 1‐year graft survival was significantly lower in the group deviating from the national protocol compared with those patients following the national protocol: 68.4% (95% CI, 42.8%‐84.4%) versus 94.8% (95% CI, 86.5%‐98.0%; P < 0.01). There were 14 patients who died, including 2 after primary 2 after primary non function, and 10 related to liver cancer recurrence. Only 1 case of ischemic cholangiopathy was observed at month 18 in this series, and the patient underwent a successful retransplant. During the first 4 years, excellent LT results were observed where the national protocol was followed. Systematic use of NRP limits liver damage induced by warm ischemia and provides excellent cDCD organs for transplant.

2020-02-01·American Journal of Cardiovascular Drugs4区 · 医学

Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial

4区 · 医学

Article

作者: Eberli, Franz ; Besse, Bruno ; Darius, Harald ; Drouet, Ludovic ; the AEGEAN Study Investigators ; Chan, Anthony ; Vicaut, Eric ; Lane, Deirdre A. ; Crijns, Harry J. ; Cosyns, Bernard ; Montalescot, Gilles ; Brotons, Carlos ; D'Angelo, Armando

INTRODUCTIONAdherence to non-vitamin-K oral anticoagulants (NOACs) may be lower than to vitamin K antagonists because NOACs do not require routine monitoring.OBJECTIVEWe assessed the impact of an educational program on adherence and persistence with apixaban in patients with non-valvular atrial fibrillation (NVAF).METHODSPatients with NVAF eligible for NOACs with one or more stroke risk factor (prior stroke/transient ischemic attack, age ≥ 75 years, hypertension, diabetes, or symptomatic heart failure) were randomized (1:1) to standard of care (SOC) or SOC with additional educational (information booklet, reminder tools, virtual clinic access). The primary outcome was adherence to apixaban (2.5 or 5 mg twice daily) at 24 weeks. Patients receiving the educational program were re-randomized (1:1) to continue the program for 24 further weeks or to switch to secondary SOC. Implementation adherence and persistence were reassessed at 48 weeks.RESULTSIn total, 1162 patients were randomized (SOC, 583; educational program, 579). Mean implementation adherence ± standard deviation (SD) at 24 weeks was 91.6% ± 17.1 for SOC and 91.9% ± 16.1 for the educational program arm; results did not differ significantly between groups at any time-point. At 48 weeks, implementation adherence was 90.4% ± 18.0, 90.1% ± 18.6, and 89.3% ± 18.1 for continued educational program, SOC, and secondary SOC, respectively; and corresponding persistence was 86.1% (95% confidence interval [CI] 81.3-89.7), 85.2% (95% CI 81.5-88.2), and 87.8% (95% CI 83.4-91.1). Serious adverse events were similar across groups.CONCLUSIONHigh implementation adherence and persistence with apixaban were observed in patients with NVAF receiving apixaban. The educational program did not show additional benefits.CLINICAL TRIAL REGISTRATIONThis study is registered at ClinicalTrials.gov [NCT01884350].

2012-11-29·New England Journal of Medicine1区 · 医学

Bedside Monitoring to Adjust Antiplatelet Therapy for Coronary Stenting

1区 · 医学

Article

作者: Range, Gregoire ; Abtan, Jeremie ; Saint-Etienne, Christophe ; Kerneis, Mathieu ; Monsegu, Jacques ; Carrie, Didier ; Boueri, Ziad ; Henry, Patrick ; Sabouret, Pierre ; Van Belle, Eric ; Motreff, Pascal ; O′Connor, Stephen A. ; Beygui, Farzin ; Vicaut, Eric ; Belle, Loic ; Montalescot, Gilles ; Pouillot, Christophe ; Barthelemy, Olivier ; Aubry, Pierre ; Rousseau, Helene ; Elhadad, Simon ; Cuisset, Thomas ; Cayla, Guillaume ; Silvain, Johanne ; Collet, Jean-Philippe

BACKGROUNDPatients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring offers the opportunity to improve outcomes after coronary stenting by individualizing therapy.METHODSWe randomly assigned 2440 patients scheduled for coronary stenting at 38 centers to a strategy of platelet-function monitoring, with drug adjustment in patients who had a poor response to antiplatelet therapy, or to a conventional strategy without monitoring and drug adjustment. The primary end point was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization 1 year after stent implantation. For patients in the monitoring group, the VerifyNow P2Y12 and aspirin point-of-care assays were used in the catheterization laboratory before stent implantation and in the outpatient clinic 2 to 4 weeks later.RESULTSIn the monitoring group, high platelet reactivity in patients taking clopidogrel (34.5% of patients) or aspirin (7.6%) led to the administration of an additional bolus of clopidogrel, prasugrel, or aspirin along with glycoprotein IIb/IIIa inhibitors during the procedure. The primary end point occurred in 34.6% of the patients in the monitoring group, as compared with 31.1% of those in the conventional-treatment group (hazard ratio, 1.13; 95% confidence interval [CI], 0.98 to 1.29; P=0.10). The main secondary end point, stent thrombosis or any urgent revascularization, occurred in 4.9% of the patients in the monitoring group and 4.6% of those in the conventional-treatment group (hazard ratio, 1.06; 95% CI, 0.74 to 1.52; P=0.77). The rate of major bleeding events did not differ significantly between groups.CONCLUSIONSThis study showed no significant improvements in clinical outcomes with platelet-function monitoring and treatment adjustment for coronary stenting, as compared with standard antiplatelet therapy without monitoring. (Funded by Allies in Cardiovascular Trials Initiatives and Organized Networks and others; ARCTIC ClinicalTrials.gov number, NCT00827411.).

项与 Centre Hospitalier Universitaire Pitie-Salpetriere 相关的新闻（医药）

2018-04-12

·NS Medical Devices

Medtronic gets CE mark for Visualase MRI-guided laser ablation system

Medtronic has secured CE mark approval for the Visualase MRI-guided laser ablation system, which can be used in neurosurgery procedures. With the Visualase system, laser energy is delivered to the target area using an applicator. As light is delivered through the applicator, temperatures in the target area begin to rise, destroying the unwanted soft tissue1. Because Visualase procedures are guided by MRI images, the procedure can provide precise and controlled ablation. Due to the minimally invasive nature of the procedure, patients typically go home the next day.1-10 "The Visualase system will give neurosurgeons an additional minimally invasive option to precisely target and treat small areas of tissue," said Professor Jürgen Voges, M.D., from Magdeburg, Germany. "We are looking forward to offering this procedure to our patients." The Visualase MRI-Guided Laser Ablation System received Food and Drug Administration (FDA) clearance in the United States in July 2007 to necrotize or coagulate soft tissue. Medtronic is currently involved in a pivotal SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy) study in the United States to support an expanded FDA indication for the treatment of epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE), the most common form of partial or localization related epilepsy. "After supporting the FDA clearance with our completion of the first in-human study of the Visualase system in 2006 in Paris, I am excited the technology has arrived in Europe," said Professor Alexandre C. Carpentier, neurosurgeon from Pitie Salpetriere university hospital, Greater Paris University Hospitals – AP-HP of Paris, France. "The introduction of Visualase to European physicians ensures that more patients will have access to this beneficial technology," said Brett Wall, senior vice president and president of Medtronic's Brain Therapies division, which is part of the Restorative Therapies Group. "This latest milestone is a testament to our commitment to expanding therapeutic options for physicians and their patients. Source: Company Press Release

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100 项与 Centre Hospitalier Universitaire Pitie-Salpetriere 相关的转化医学

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