更新于：2024-11-01

Centre Hospitalier Departemental Vendee

France

更新于：2024-11-01

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项与 Centre Hospitalier Departemental Vendee 相关的临床试验

NCT06263816 / Not yet recruiting临床3期IIT

Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial

Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.
The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial.

开始日期2024-11-15

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

[+10]

NCT06632691 / RecruitingN/AIIT

Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis: a Randomised Controlled Trial

Haemorrhagic rectocolitis is an inflammatory bowel disease that continuously affects the rectum and colon, with lesions that extend variably from the rectum into the upstream colon. This disease requires repeated assessment of both clinical activity (transcribed by the clinical Mayo score) and endoscopic activity. ACCEPT study showed that the acceptability of rectosigmoidoscopy is low, and the main determinants of this low acceptability were pain and bloating (51%) and embarrassment during the examination (30%).
Virtual reality headsets has analgesic and anxiolytic properties, thanks to specially designed virtual environments that apply different principles such as medical hypnosis, music therapy and cardiac coherence to enhance therapeutic action.
The aim of our project is to study the benefit of medical hypnosis provided by the use of a virtual reality headset in terms of tolerance of lower digestive endoscopy in patients with ulcerative colitis.

开始日期2024-10-15

申办/合作机构

Centre Hospitalier Departemental Vendee

NCT05469815 / Not yet recruitingN/AIIT

Lost Children Society (LCS), Metacognitive Training Integrated Into an Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients : a Pilot Study on Feasibility

The Lost Children Society (LCS) is a Therapeutic TableTop Role-Playing Game specifically developed for early-onset schizophrenia patient.
It is performed online via a secure teleconsultation and videoconference platform.
Patients are connected from their home, on their personal computer or tablet, equipped with headsets with microphone.
This study aims to validate the feasibility of this online Therapeutic TableTop Role Playing Game.

开始日期2024-10-01

申办/合作机构

Centre Hospitalier Departemental Vendee

100 项与 Centre Hospitalier Departemental Vendee 相关的临床结果

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0 项与 Centre Hospitalier Departemental Vendee 相关的专利（医药）

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项与 Centre Hospitalier Departemental Vendee 相关的文献（医药）

2019-10-15·JAMA

The SEPSIS-ACT Randomized Clinical Trial

Article

作者: Lefrant, Jean-Yves ; Decruyenaere, Johan ; Graves, Todd ; Krell, Kenneth ; Kjølbye, Anne Louise ; Quenot, Jean-Pierre ; Muller, Grégoire ; Lewis, Roger J. ; Mercier, Emmanuelle ; Dive, Alain-Michel ; Vignon, Philippe ; François, Bruno ; Jacobsen, Karsten ; Bestle, Morten H. ; Angus, Derek C. ; Russell, James A. ; Mira, Jean-Paul ; Carlsen, Jan E. ; Thorsen-Meyer, Hans-Christian ; Dugernier, Thierry ; Rasmussen, Bodil Steen ; Berry, Scott M. ; Vang, Marianne Lauridsen ; Wittebole, Xavier ; Vander Laenen, Margot ; Yealy, Donald M. ; Opal, Steven M. ; Bruel, Cédric ; Vinatier, Isabelle ; Brulé, Noëlle ; Windeløv, Nis A. ; Pickkers, Peter ; Laterre, Pierre-Francois ; Perner, Anders ; Asfar, Pierre ; Megarbane, Bruno ; Blemings, Allan ; Wichmann, Sine

IMPORTANCENorepinephrine, the first-line vasopressor for septic shock, is not always effective and has important catecholaminergic adverse effects. Selepressin, a selective vasopressin V1a receptor agonist, is a noncatecholaminergic vasopressor that may mitigate sepsis-induced vasodilatation, vascular leakage, and edema, with fewer adverse effects.OBJECTIVETo test whether selepressin improves outcome in septic shock.DESIGN, SETTING, AND PARTICIPANTSAn adaptive phase 2b/3 randomized clinical trial comprising 2 parts that included adult patients (n = 868) with septic shock requiring more than 5 μg/min of norepinephrine. Part 1 used a Bayesian algorithm to adjust randomization probabilities to alternative selepressin dosing regimens and to trigger transition to part 2, which would compare the best-performing regimen with placebo. The trial was conducted between July 2015 and August 2017 in 63 hospitals in Belgium, Denmark, France, the Netherlands, and the United States, and follow-up was completed by May 2018.INTERVENTIONSRandom assignment to 1 of 3 dosing regimens of selepressin (starting infusion rates of 1.7, 2.5, and 3.5 ng/kg/min; n = 585) or to placebo (n = 283), all administered as continuous infusions titrated according to hemodynamic parameters.MAIN OUTCOMES AND MEASURESPrimary end point was ventilator- and vasopressor-free days within 30 days (deaths assigned zero days) of commencing study drug. Key secondary end points were 90-day mortality, kidney replacement therapy-free days, and ICU-free days.RESULTSAmong 868 randomized patients, 828 received study drug (mean age, 66.3 years; 341 [41.2%] women) and comprised the primary analysis cohort, of whom 562 received 1 of 3 selepressin regimens, 266 received placebo, and 817 (98.7%) completed the trial. The trial was stopped for futility at the end of part 1. Median study drug duration was 37.8 hours (IQR, 17.8-72.4). There were no significant differences in the primary end point (ventilator- and vasopressor-free days: 15.0 vs 14.5 in the selepressin and placebo groups; difference, 0.6 [95% CI, -1.3 to 2.4]; P = .30) or key secondary end points (90-day mortality, 40.6% vs 39.4%; difference, 1.1% [95% CI, -6.5% to 8.8%]; P = .77; kidney replacement therapy-free days: 18.5 vs 18.2; difference, 0.3 [95% CI, -2.1 to 2.6]; P = .85; ICU-free days: 12.6 vs 12.2; difference, 0.5 [95% CI, -1.2 to 2.2]; P = .41). Adverse event rates included cardiac arrhythmias (27.9% vs 25.2% of patients), cardiac ischemia (6.6% vs 5.6%), mesenteric ischemia (3.2% vs 2.6%), and peripheral ischemia (2.3% vs 2.3%).CONCLUSIONS AND RELEVANCEAmong patients with septic shock receiving norepinephrine, administration of selepressin, compared with placebo, did not result in improvement in vasopressor- and ventilator-free days within 30 days. Further research would be needed to evaluate the potential role of selepressin for other patient-centered outcomes in septic shock.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT02508649.

2019-05-20·Journal of Clinical Oncology

TAXOMET: A French prospective multicenter randomized controlled phase II study comparing docetaxel plus metformin versus docetaxel plus placebo in mCRPC.

作者: Priou, Frank ; Cavaglione, Gerard ; Viotti, Julien ; Borchiellini, Delphine ; El Kouri, Claude ; Guillot, Aline ; Hoch, Benjamin ; Schiappa, Renaud ; Hilgers, Werner ; Deville, Jean-Laurent ; Pujalte Martin, MARC ; Ferrero, Jean-Marc ; Tanti, Jean François ; Bost, Frederic ; Lharidon, Tifenn ; Largillier, Remy ; Besson, Dominique ; Paoli, Jean Baptiste

5004 Background: Docetaxel (DOCE) is a standard of care in metastatic castration-resistant prostate cancer (mCRPC). Several retrospective cohort studies suggest a decrease in PC incidence and mortality with metformin (MET). MET has also demonstrated anti-tumor activity in PC preclinical models, with increase apoptosis when added to DOCE. The addition of MET could enhance DOCE efficacy in mCRPC patients (pts). Methods: TAXOMET is a phase II prospective multicentric randomized controlled trial. Non-diabetic mCRPC pts were assigned 1:1 to receive DOCE 75mg/m2 every 21 days + prednisone (P) 5 mg twice a day and either MET 850mg twice a day (arm A) or placebo (arm B), up to 10 cycles. The primary end point was PSA response rate (≥50% decrease). Main secondary endpoints included objective response rate (ORR, according to RECIST v1.1), clinical and biological progression-free survival (PFS), overall survival (OS), toxicity and quality of life (QoL). Comparisons between arm A and B were performed using Chi² test for qualitative data and Log-rank test for survival data. Results: From January 2013 to December 2015, 99 pts were randomized (50 pts in arm A and 49 pts in arm B) in 10 french centers, and 95 pts were evaluable. No difference was observed between arm A and arm B in PSA-response rate (72% in both arms), ORR (28% in both arms), clinical or biological mPFS (7.3 months vs 5.8 months p = 0.848) and mOS (24.2 months (95CI: 17.2 – 33.7) vs 19.7 months (95CI: 14.8 – 36.8), p = 0.53), respectively. There was no difference between arms in adverse events, except a trend for diarrhea to be more common with MET (70% in arm A vs 50% in arm B, p = 0.072), but few grade 3-4 events. There was no difference in QoL according to QLQ-C30 score between the two arms during the treatment period. Conclusions: This is the first prospective randomized controlled trial to evaluate the combination of MET with DOCE+P in mCRPC. The addition of MET has no meaningful clinical benefit in this setting. Clinical trial information: NCT01796028.

2019-04-01·BMJ Open4区 · 医学

Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial

4区 · 医学

ArticleOA

作者: Tching-Sin, Martine ; Aubert, Hélène ; Winer, Norbert ; Rogers, Natasha K ; Badon, Virginie ; Boivin, Marion ; Dochez, Vincent ; Cabridain, Clémentine ; Faurel-Paul, Elodie ; Riochet, David ; Lassel, Linda ; Planche, Lucie ; Maruani, Annabel ; Bodinier, Marie ; Kaeffer, Bertrand ; Perrotin, Franck ; Barbarot, Sebastien ; Droitcourt, Catherine

IntroductionAtopic dermatitis (AD) is a chronic inflammatory disease affecting 10%–15% of children in Europe. There is a need for new primary preventive therapeutic strategies in at-risk populations. Recent research has indicated that atopic diseases are associated with a disrupted gut microbial ‘balance’ in early life raising the possibility that interventions which yield optimal patterns of microflora could improve host’s health. Prebiotics, sugars with immunomodulatory properties that stimulate the diversity of the digestive microbiota, are ideal candidates for such research. So far, most clinical trials have focused on improving infant gut colonisation postnatally. However, prenatal life is a crucial period during which different tolerance mechanisms are put in place. We aim to determine whether antenatal prebiotics supplementation prevents AD in high-risk children.Methods and analysisThis is a randomised, multicentre, double-blind, trial to evaluate the effectiveness of antenatal prebiotic maternal supplementation (galacto-oligosaccharide/inulin) in pregnant women versus placebo on the occurrence of AD at 1 year of age in at-risk children (defined as having a maternal history of atopic disease). Participating women will be randomised to daily ingestion of a prebiotics or placebo (maltodextrin) from 20 weeks’ gestation until delivery. The primary outcome is the prevalence of AD at 1 year of age, using the version of the UK Working Party Diagnostic Criteria optimised for preventive studies. Key secondary endpoints are AD severity, quality of life and prebiotics tolerance. The target sample size is 376 women (188 patients per group) which will provide 80% power to detect a 33% reduction of the risk of AD in the verum group (α=0.05). The primary analysis will be based on the intention-to-treat principle.Ethics and disseminationResults will be presented in peer-reviewed journals and at international conferences. Ethics approval for the study was obtained from the institutional ethical review board of ‘Comité de Protection des Personnes Sud Ouest—Outre-Mer III’ of the University Hospital Centre of Bordeaux (2017/13).Trial registration numberNCT03183440; Pre-results.

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100 项与 Centre Hospitalier Departemental Vendee 相关的转化医学

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