Search results for " trial"

Indications of PCSK9 inhibitors in clinical practice. Recommendations of the Spanish Society of Arteriosclerosis (SEA), 2019

2019

A group of experts convened by the Spanish Society of Arteriosclerosis (SEA) has been in charge of updating the SEA document on the indications of PCSK9 inhibitors (PCSK9i) in clinical practice that was published in 2016. This update is justified by the fact that the data from clinical trials carried out on a large scale with PCSK9i have shown that in addition to their high potency to lower atherogenic cholesterol, they reduce the risk of atherosclerotic cardiovascular disease, both in patients with stable disease, and with recent disease, and with a high degree of security. This update provides the recommendations and level of evidence for the prescription of iPCSK9 in patients with homozy…

Methodological matters on an Alzheimer's dementia trial: is a double-blind randomized controlled study design sufficient to draw strong conclusions o…

2007

Antioxidant Supplements and Diabetic Retinopathy

2014

Abstract Conventional treatments for diabetic retinopathy (DR) includes glycemic control, laser photocoagulation, vitrectomy, intravitreal triamcinolone, and intravitreal anti-vascular endothelial growth factor agents. However these strategies have not proved capable of halting the progression of this disease in all cases. The mechanisms leading to DR are not fully understood, but there is a growing body of evidence showing that oxidative stress plays a pivotal role in the development of this diabetic complication. In fact it has been proposed that oxidative stress is the initial and maintaining event that triggers and provides feedback to the other pathophysiological pathways related to DR…

Randomized Trial of Lenalidomide and Dexamethasone Versus Clarythromycin, Lenalidomide and Dexamethasone As First Line Treatment in Patients with Mul…

2019

Continuous treatment with lenalidomide (R) and dexamethasone (d) is a standard of care for multiple myeloma (MM) patients (pts) not candidates for autologous stem cell transplantation (ASCT). As previously reported, the addition of Clarithromycin (C) to Rd has proven to be safe and effective, and case-control analyses suggested a significant additive value with the combination. C optimizes the therapeutic effect of glucocorticoids by increasing the area under the curve, has immunomodulatory effects and may have direct antineoplastic properties. However, there are not randomized phase III trials confirming these results. GEM-Claridex in an open, randomized, phase III trial for untreated new…

Rituximab in Combination with CHOP in Patients with Follicular Lymphoma: Analysis of Treatment Outcome of 552 Patients Treated in a Randomized Trial …

2008

Abstract We have previously reported that compared to CHOP alone the addition of Rituximab (R) to CHOP significantly increases the response rate (RR), the time to treatment failure (TTF) and also the overall survival (OS) in patients with newly diagnosed advanced follicular lymphoma. However, in the previous report, the median observation time was short with 18 months and no data were reported on the outcome of different risk groups according to the FLIPI (Hiddemann et al., Blood 2005). We now report on the treatment outcome of 552 patients with advanced stage follicular lymphoma randomized between R-CHOP versus CHOP alone after a median follow up of 58 months. Responding patients < …

A randomized trial of quilizumab in adults with refractory chronic spontaneous urticaria

2016

Clofarabine Significantly Increases Eradication of Minimal Residual Disease of B-Precursor ALL Compared to High-Dose Cytarabine in Randomized Trial C…

2020

Background Since the FDA approval of clofarabine for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL) at childhood, several studies have been launched which put clofarabine under scrutiny in combination with other cytostatic drugs as second or third line therapy. As a novel treatment-strategy we introduced the combination of clofarabine with pegylated asparaginase (PEG-ASP) in a randomized fashion in comparison to the standard consolidation course with high dose cytarabine (Hidac) combined with PEG-ASP into the frontline management of ALL within the CoALL 08-09 protocol. The primary objective of the study was to compare the MRD based assessment of the cytotoxic eff…

Cardiovascular consequences of sleep disordered breathing: the role of CPAP treatment

2020

CPAP treatment decreases BP in OSA patients, especially in severe OSA, and in patients with poorly controlled BP. OSA adversely affects heart function and remodelling, but its role in the pathogenesis of HF remains unclear. Similarly, the impact of CPAP is uncertain, and results of the ongoing ADVENT-HF trial will provide more information. Several experimental studies in animals and humans indicate a central role of intermittent hypoxia in atherogenesis through multiple mechanisms. However, randomised controlled trials (RCTs) in patients with CAD and OSA found no difference in outcomes between CPAP-treated and untreated patients. The negative results of secondary prevention RCTs may be the …

VI: Konfidenzintervalle - die Alternative zum p-Wert

2003

Confidence intervals combine the ideas of clinical relevance and statistical significance by using one instructive expression, which enables remarkable reduction of table structures and result sections in scientific publications. Confidence interval based conclusions can be transferred from a clinical trial to its underlying study population with respect to a residual statistical error probability, i.e. the significance concept is retained. However, their presentation using the original unit of the clinical endpoint under consideration allows for immediate interpretation of the results' clinical impact. For example, the comparison of two therapy groups based on a binary endpoint becomes fea…

A Dose-Dependent Improvement in Exercise Tolerance in Patients With Stable Angina Treated With Mildronate: A Clinical Trial “MILSS I”

2011

Objective. To assess the efficacy of various doses of Mildronate in combination with standard therapy for the exercise tolerance of patients with stable angina pectoris. The primary efficacy variable was the change in exercise time in bicycle ergometry from the baseline to 12 weeks of treatment. The secondary endpoints were the changes in maximum achieved load and time to the onset of angina from the baseline to week 12. Material and Methods. A total of 512 patients with chronic coronary heart disease who had ischemia as the limiting factor in the exercise test from 72 study centers in 4 countries were enrolled in this prospective, randomized, double-blind, placebo controlled phase 2 study.…