Search results for "Clinical Research"
showing 10 items of 474 documents
Family perceptions of clinical research and the informed consent process in the ICU
2020
Abstract Purpose We investigated experiences of families who provide consent for research on behalf of a loved-one hospitalized in intensive care (ICU). Methods Multicentre, qualitative, descriptive study using semi-directive interviews in 3 ICUs. Eligible relatives were aged >18 years, and had provided informed consent for a clinical trial on behalf of a patient hospitalized in ICU. Interviews were conducted from 06/2018 to 06/2019 by a qualified sociologist, recorded and transcribed. Results Fifteen relatives were interviewed; average age 50.3 ± 15 years. All emphasized their interest in clinical research, seeing it as a duty. Involving their loved-one in research allowed them to find mea…
Robotic Radical Hysterectomy After Concomitant Chemoradiation in Locally Advanced Cervical Cancer: A Prospective Phase II Study
2016
Study Objective To assess the feasibility of total robotic radical surgery (TRRS) in patients with locally advanced cervical cancer (LACC) who receive chemoradiation therapy (CT/RT). Design A prospective (preplanned) study of a nonrandomized controlled trial (Canadian Task Force classification level 2). Setting Catholic University of the Sacred Hearth, Rome, Italy. Patients Between September 2013 and January 2016, a total of 40 patients with LACC (Fédération Internationale de Gynécologie et d'Obstétrique stage IB2–III) were enrolled in the study. Interventions Robotic radical hysterectomy (RRH) plus pelvic and/or aortic lymphadenectomy was attempted within 6 weeks after CT/RT. The feasibili…
Docetaxel and oxaliplatin in the second-line treatment of platinum-sensitive recurrent ovarian cancer: a phase II study.
2007
ABSTRACT Background A prospective phase II study was conducted to evaluate the efficacy and toxicity of the combination docetaxel (Taxotere) (DTX) and oxaliplatin (OXA) in ovarian cancer patients recurring after a platinum-free interval (PFI) >12 months. Patients and methods DTX, 75 mg/m2, was administered by 60 min i.v. infusion, followed by OXA, 100 mg/m2, given by a 2 h i.v., on day 1 every 21 days. Results From October 2003 to June 2006, 43 ovarian cancer patients were enrolled. Median PFI was 26 months. All patients were available for response evaluation: 17 complete responses and 12 partial responses were registered, for an overall response rate of 67.4%. The median response duration …
Liposomal-encapsulated doxorubicin plus cyclophosphamide as first-line therapy in metastatic breast cancer: a phase II multicentric study
2007
Abstract Background The objective of this study is to evaluate the efficacy and toxicity of the liposome-encapsulated doxorubicin (TLC D-99) plus cyclophosphamide (CTX) as first-line treatment of metastatic breast cancer in light of the potential cardioprotective effect of TLC D-99 as compared with conventional doxorubicin. Materials and methods Sixty-seven patients as defined according Simon's two-stage phase II design were enrolled. They received TLC D-99 at the dosage of 60 mg/m2 plus CTX 600 mg/m2, with cycles repeated every 3 weeks. Cardiac function was assessed by ultrasonography at baseline and every two cycles. Results The principal characteristics of the 67 enrolled patients were a…
Improved short-term outcomes of kidney transplants in controlled donation after the circulatory determination of death with the use of normothermic r…
2021
Normothermic Regional Perfusion (NRP) allows the in situ perfusion of organs with oxygenated blood in donation after the circulatory determination of death (DCDD). We aimed at evaluating the impact of NRP on the short-term outcomes of kidney transplants in controlled DCDD (cDCDD). This is a multicenter, nationwide, retrospective study comparing cDCDD kidneys obtained with NRP versus the standard rapid recovery (RR) technique. During 2012-2018, 2,302 cDCDD adult kidney transplants were performed in Spain using NRP (n=865) or RR (n=1,437). The study groups differed in donor and recipient age, warm and cold ischemic time and use of ex situ machine perfusion. Transplants in the NRP group were m…
Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion
2021
International audience; Severe asthma often remains uncontrolled despite effective treatments and evidence-based guidelines. A group of global experts in asthma and biologic medications from nine countries considered the most relevant clinical variables to manage severe asthma in adult patients and guide treatment choice. The resulting recommendations address the investigation of biomarker levels (blood eosinophil count along with fractional concentration of exhaled nitric oxide [FeNO]), clinical features (oral corticosteroid [OCS] dependency, specific comorbid disease entities associated with severe type 2 asthma), and safety considerations. Current evidence suggests that biomarkers, inclu…
Abstract TMP17: Revacept, an Inhibitor of Platelet Adhesion in Patients With Symptomatic Carotid Artery Stenosis. Safety Data From the International …
2020
Introduction: Revacept is a novel vascular lesion-directed inhibitor of platelet adhesion and thrombus formation, exhibiting no effects on the homeostatic functions of circulating platelets. Objective: The effects of Revacept on plaque-mediated thrombosis were investigated in patients with symptomatic stenosis of the internal carotid artery (at least 50%, following ECST-criteria). Methods: Within an international, prospective, multicenter (n=16), randomized trial 158 patients could be randomized to receive placebo, or 40/120 mg Revacept by intravenous infusion over 20 minutes. Cerebrovascular events and cardiovascular complications were followed up to 3 months. Results: 158 patients were f…
Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia
2021
IntroductionIn the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).Material and methodsWe report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manu…
Enzyme replacement therapy for mucopolysaccharidosis VI: evaluation of long-term pulmonary function in patients treated with recombinant human N-acet…
2010
Pulmonary function is impaired in untreated mucopolysaccharidosis type VI (MPS VI). Pulmonary function was studied in patients during long-term enzyme replacement therapy (ERT) with recombinant human arylsulfatase B (rhASB; rhN-acetylgalactosamine 4-sulfatase). Pulmonary function tests prior to and for up to 240 weeks of weekly infusions of rhASB at 1 mg/kg were completed in 56 patients during Phase 1/2, Phase 2, Phase 3 and Phase 3 Extension trials of rhASB and the Survey Study. Forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and, in a subset of patients, maximum voluntary ventilation (MVV), were analyzed as absolute volume in liters. FEV1 and FVC showed little change f…
Association between COX-2 rs 6681231 genotype and interleukin-6 in periodontal connective tissue. A pilot study.
2014
[Objectives] The aim of this pilot study was to investigate associations between IL-6 and COX-2 expression in gingival biopsies and both clinical diagnosis and genotypes in the IL-6 and COX-2 genes. [Design] A case-control study included 41 gingival biopsies obtained from Caucasian patients grouped according to clinical diagnosis of gingival health (n = 10), gingivitis (n = 15) or chronic periodontitis (n = 16). Immunohistochemistry analyses were performed to determine COX-2 expression in lamina propria, IL-6 expression in lamina propria and gingival epithelium and level of inflammatory cell infiltrate. Individual DNA was extracted and genotyped by real-time PCR for IL6 SNPs rs 2069827 and …