scholarly journals FFCD-1004 Clinical Trial: Impact of Cytidine Deaminase Activity on Clinical Outcome in Gemcitabine-Monotherapy Treated Patients

PLoS ONE ◽  
2015 ◽  
Vol 10 (8) ◽  
pp. e0135907 ◽  
Author(s):  
Cindy Serdjebi ◽  
Johan Gagnière ◽  
Jérôme Desramé ◽  
Francine Fein ◽  
Rosine Guimbaud ◽  
...  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.


2021 ◽  
Vol 49 (4) ◽  
pp. 982-993
Author(s):  
Anne-Sofie Agergaard ◽  
Rene B. Svensson ◽  
Nikolaj M. Malmgaard-Clausen ◽  
Christian Couppé ◽  
Mikkel H. Hjortshoej ◽  
...  

Background: Loading interventions have become a predominant treatment strategy for tendinopathy, and positive clinical outcomes and tendon tissue responses may depend on the exercise dose and load magnitude. Purpose/Hypothesis: The purpose was to investigate if the load magnitude influenced the effect of a 12-week loading intervention for patellar tendinopathy in the short term (12 weeks) and long term (52 weeks). We hypothesized that a greater load magnitude of 90% of 1 repetition maximum (RM) would yield a more positive clinical outcome, tendon structure, and tendon function compared with a lower load magnitude of 55% of 1 RM when the total exercise volume was kept equal in both groups. Study Design: Randomized clinical trial; Level of evidence, 1. Methods: A total of 44 adult participants with chronic patellar tendinopathy were included and randomized to undergo moderate slow resistance (MSR group; 55% of 1 RM) or heavy slow resistance (HSR group; 90% of 1 RM). Function and symptoms (Victorian Institute of Sport Assessment–Patella questionnaire [VISA-P]), tendon pain during activity (numeric rating scale [NRS]), and ultrasound findings (tendon vascularization and swelling) were assessed before the intervention, at 6 and 12 weeks during the intervention, and at 52 weeks from baseline. Tendon function (functional tests) and tendon structure (ultrasound and magnetic resonance imaging) were investigated before and after the intervention period. Results: The HSR and MSR interventions both yielded significant clinical improvements in the VISA-P score (mean ± SEM) (HSR: 0 weeks, 58.8 ± 4.3; 12 weeks, 70.5 ± 4.4; 52 weeks, 79.7 ± 4.6) (MSR: 0 weeks, 59.9 ± 2.5; 12 weeks, 72.5 ± 2.9; 52 weeks, 82.6 ± 2.5), NRS score for running, NRS score for squats, NRS score for preferred sport, single-leg decline squat, and patient satisfaction after 12 weeks, and these were maintained after 52 weeks. HSR loading was not superior to MSR loading for any of the measured clinical outcomes. Similarly, there were no differences in functional (strength and jumping ability) or structural (tendon thickness, power Doppler area, and cross-sectional area) improvements between the groups undergoing HSR and MSR loading. Conclusion: There was no superior effect of exercising with a high load magnitude (HSR) compared with a moderate load magnitude (MSR) for the clinical outcome, tendon structure, or tendon function in the treatment of patellar tendinopathy in the short term. Both HSR and MSR showed equally good, continued improvements in outcomes in the long term but did not reach normal values for healthy tendons. Registration: NCT03096067 (ClinicalTrials.gov identifier)


2015 ◽  
Vol 1 (3) ◽  
pp. 11-18 ◽  
Author(s):  
Babak Bakhshayesh-Eghbali ◽  
Mohadese Hajinnori ◽  
Seyed-Mohammad Seyed-Saadat ◽  
Seyed-Nazanin Seyed-Saadat ◽  
Ehsan Kazemnezhad-Leili ◽  
...  

1985 ◽  
Vol 147 (2) ◽  
pp. 67-74 ◽  
Author(s):  
Jean-Louis Pérignon ◽  
Jacques Chaléon ◽  
Guy Leverger ◽  
Anne-Marie Houllier ◽  
Laure Thuillier ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Puymirat ◽  
F Schiele ◽  
F Roubille ◽  
V Tea ◽  
J Ferrieres ◽  
...  

Abstract Background The main potential benefits of participating in a clinical trial is to have access to a treatment that is not available yet and to have a regular and careful attention from physicians. Several data have suggested that inclusion in a research study was associated with better clinical outcome. Aims The aim of this study is to describe the prevalence of inclusions in a research study (i.e., device or medication), clinical characteristics, management and clinical outcome in patients admitted for acute myocardial infarction (AMI) according to participation in a research study (versus not) using data from the French registries of Acute ST-or non-ST-elevation Myocardial infarction (FAST-MI) 2010 and 2015. Methods We used data from 2 one-month French registries, conducted 5 years apart, including 9,414 AMI admitted to coronary or intensive care units. We analyzed baseline characteristics, management and one-year survival according to participation in a research study. Results From 2010 to 2015, the prevalence of patients included in a research study decreased from 6.8% to 3.6% (P<0.001). Inclusions were performed mainly in university hospitals (8%). Clinical characteristics according to participation in a research study were strongly different. Overall, patients included in a research study were younger (61.2±12.7 vs 65.7±14.1; P<0.001) with less previous medical history and co-morbidities. Clinical presentation was preferentially a ST-elevation myocardial infarction (STEMI: 70% vs 52%; P<0.001) in these patients who had a lower GRACE score (133±32 vs. 141±35; P<0.001). The use of invasive strategies was more used in patients included in a research study (coronary angiogram: 99% vs 95%, P<0.001) as prescriptions of recommended medications (i.e., antiplatelet agents, beta-blockers, angiotensin-converting-enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) and statins) at discharge (72% vs 63%; P<0.001). In a cox multivariate analysis, participation in a research study was not associated with lower mortality at one-year (HR= 0.68, 95% CI, 0.39–1.18, P=0.17). Similar results were observed in patients discharge alive (HR= 0.81, 95% CI, 0.44–1.48, P=0.49). Recommended medications were however more used in patients included in a clinical trial (OR=1.34; 95% CI, 1.09–1.65; P=0.007). Conclusions The number of inclusions in a research study related to AMI in France is low. Our data suggest that patients included in a research study are selected and received more recommended medications and invasive strategies. However, this management is not associated with a lower mortality at one-year. Funding Acknowledgement Type of funding source: None


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