Search results for "Clinical endpoint"
showing 10 items of 339 documents
Prognosis of adults with left ventricular non compaction: Results from a prospective multricentric french study
2021
Background Left ventricular non compaction (LVNC) is a rare cause of cardiomyopathy related to abnormal in utero myocardial development, leading to prominent trabeculations. Its prognosis remains unclear with conflicting data and mortality ranging from 2 to 38%. Purpose The aim of this study was to define the prognosis of newly diagnosed LVNC as compared to recently diagnosed dilated cardiomyopathy (DCM). Methods A prospective multicentric study with a 2-year follow-up was designed. The primary endpoint combined cardiovascular death, heart transplantation and hospitalisation for cardiovascular events. Three groups of patients were defined: Group A: new cases of LVNC, Group B: new cases of D…
Comparative Effectiveness of DPP-4 Inhibitors Versus Sulfonylurea for the Treatment of Type 2 Diabetes in Routine Clinical Practice: A Retrospective …
2018
Introduction DPP-4 inhibitors (DPP4i) and sulfonylureas are popular second-line therapies for type 2 diabetes (T2D), but there is a paucity of real-world studies comparing their effectiveness in routine clinical practice. Methods This was a multicenter retrospective study on diabetes outpatient clinics comparing the effectiveness of DPP4i versus gliclazide extended release. The primary endpoint was change from baseline in HbA1c. Secondary endpoints were changes in fasting plasma glucose, body weight, and systolic blood pressure. Automated software extracted data from the same clinical electronic chart system at all centers. Propensity score matching (PSM) was used to generate comparable coh…
Grazoprevir/elbasvir for the immediate treatment of recently acquired HCV genotype 1 or 4 infection in MSM.
2020
Abstract Background In Europe, increases in HCV infection have been observed over the last two decades in MSM, making them a key population for recently acquired HCV. Alternative combinations of direct-acting antiviral agents against early HCV infection need to be assessed. Patients and methods In this pilot trial, MSM with recently acquired genotype 1 or 4 HCV infection were prospectively included and received 8 weeks of oral grazoprevir 100 mg and elbasvir 50 mg in a fixed-dose combination administered once daily. The primary endpoint was sustained virological response evaluated 12 weeks after the end of treatment (EOT) (SVR12). Secondary endpoints were the virological characterization of…
Tumor lymphocyte immune response to preoperative radiotherapy in locally advanced rectal cancer: The LYMPHOREC study
2017
IF 7.719; International audience; Introduction: Some studies have suggested that baseline tumor-infiltrating-lymphocytes (TILs), such as CD8+ and FoxP3+ T-cells, may be associated with a better prognosis in colorectal cancer. We sought to investigate modulation of the immune response by preoperative radiotherapy (preopRT) and its impact on survival in locally advanced rectal cancer (LARC). Materials & Methods: We analyzed data for 237 patients with LARC who received RT. Density of TILS (CD8+ and FoxP3+) in intraepithelial (iTILs) and stromal compartments (sTILs) were evaluated from surgery pathological specimens and biopsies performed at baseline. The primary endpoint was to assess the impa…
Characteristics of clinical trials in rare vs. common diseases: A register-based Latvian study.
2017
Background Conducting clinical studies in small populations may be very challenging; therefore quality of clinical evidence may differ between rare and non-rare disease therapies. Objective This register-based study aims to evaluate the characteristics of clinical trials in rare diseases conducted in Latvia and compare them with clinical trials in more common conditions. Methods The EU Clinical Trials Register (clinicaltrialsregister.eu) was used to identify interventional clinical trials related to rare diseases (n = 51) and to compose a control group of clinical trials in non-rare diseases (n = 102) for further comparison of the trial characteristics. Results We found no significant diffe…
Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
2021
AIMS: Although acute heart failure (AHF) with volume overload is treated with loop diuretics, their dosing and type of administration are mainly based upon expert opinion. A recent position paper from the Heart Failure Association (HFA) proposed a step-wise pharmacologic diuretic strategy to increase the diuretic response and to achieve rapid decongestion. However, no study has evaluated this protocol prospectively. METHODS AND RESULTS: The Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure (ENACT-HF) study is an international, multicentre, non-randomized, open-label, pragmatic study in AHF patients on chronic loop diuretic therapy, admitted to the hospital for intravenous …
SGLT2 inhibitors for non-diabetic kidney disease: drugs to treat CKD that also improve glycaemia
2020
Abstract Sodium–glucose co-transporter-2 (SGLT2) inhibitors decreased cardiovascular (CV) events and improved renal outcomes in CV safety studies in type 2 diabetes melitus (T2DM) patients at high CV risk. Canagliflozin also improved kidney outcomes in diabetic kidney disease in the Canagliflozin and Renal Events in Diabetes and Nephropathy Clinical Evaluationtrial. More recently, the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) trial showed that dapagliflozin improved CV outcomes in patients with HF with or without diabetes. Protection from HF in non-diabetics was confirmed for empagliflozin in the EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Fa…
Impact of switching from mycophenolate mofetil to enteric-coated mycophenolate sodium on gastrointestinal side effects in patients with autoimmune di…
2015
Bernhard Manger,1 Falk Hiepe,2 Matthias Schneider,3 Margitta Worm,4 Peter Wimmer,5 Eva-Maria Paulus,5 Andreas Schwarting6 1University Hospital Erlangen, Med Clinic III Polyclinic, Erlangen, 2Rheumatology, University Hospital Charité, Campus Mitte, Berlin, 3Policlinic of Rheumatology, Heinrich-Heine-Universität, Düsseldorf, 4Department of Dermatology, Venereology and Allergology, University Hospital Charité, Campus Mitte, Berlin, 5Novartis Pharma GmbH, Nürnberg, 6Department of Internal Medicine, Johannes Gutenberg University, Mainz, Germany Background: The purpose of this study was to assess changes in gastrointestinal symptom severity in pati…
Clinical History and Detectable Troponin Concentrations below the 99th Percentile for Risk Stratification of Patients with Chest Pain and First Norma…
2021
Decision-making is challenging in patients with chest pain and normal high-sensitivity cardiac troponin T (hs-cTnT
Randomized, placebo-controlled, double-blind and open-label studies in the treatment and prevention of acute diarrhea with Enterococcus faecium SF68
2020
Enterococcus faecium SF68® (SF68) is a licensed pharmaceutical for treatment and prevention of diarrhea in Austria, Italy and Switzerland. However, as for other probiotics, evidence for its efficacy is based on small to medium-sized studies. Four unpublished studies on the treatment of acute diarrhea and the prevention of antibiotic-associated diarrhea were analyzed: one randomized, double blind, placebo-controlled trial (RCT) for treatment (n = 1,143), one open-label study for treatment (n = 5,093), one RCT for prevention (n = 1,397) and one open-label study for prevention (n = 4,340). Patients in the treatment-arm and the open-label studies received SF68 (b.i.d. for the prevention studies…