Search results for "clinical trial"
showing 10 items of 1656 documents
Prevention of feeding tube dislodgement with the Wiesbaden rein: a case series.
2009
We describe initial experience with the use of a new fixation method (Wiesbaden rein), which has been developed to prevent dislodgement of feeding tubes in the gastrointestinal tract. The Wiesbaden rein has been used in three patients without complication. In none of the patients was dislodgement or malfunction of the feeding tube observed. Therefore, the use of the Wiesbaden rein might prevent dislodgement of feeding tubes. Clinical trials are required before this new method can be recommended for general use.
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…
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…
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.…
Clinical research focused in European adult women with minority diseases: Do we try hard enough?
2021
We analyzed the European countries participation in clinical trials addressing to new drug development focused on rare diseases in women comparing to more prevalent diseases as breast cancer. Participation was not associated with type of healthcare system neither socio-economic features, but it was associated with population size. Protocol ratios focused on breast cancer vs. orphan drugs and rare diseases was 15:1 and 9:1, respectively, mainly focused on ovarian cancer. Protocol number was insufficient to evaluate the success of Regulation (EC) 141/2000, it is necessary to increase the scientific quality and the number of really new molecules.
Efficacy and safety of micafungin for treatment of serious Candida infections in patients with or without malignant disease
2011
The aim of this study was to evaluate micafungin efficacy for treatment of invasive candidiasis/candidaemia in patients with cancer. Modified intent-to-treat populations were analysed from two trials: one, in adults and children with confirmed Candida infection, compared micafungin (adults 100 mg day(-1); children 2 mg kg(-1) day(-1)) with liposomal amphotericin B (L-AmB 3 mg kg(-1) day(-1)); and the other, in adults only, compared micafungin (100 or 150 mg day(-1)) with caspofungin (50 mg day(-1); 70 mg loading dose). Primary efficacy endpoint in both trials was treatment success, defined as both clinical and mycological response at end of therapy. In the micafungin/L-AmB trial, 183/489 pa…
The Orogastric Tube Guide® as a novel strategy for gastric tube insertion: a prospective, randomized controlled clinical trial
2020
BACKGROUND Gastric tube insertion, either orally or nasally, is daily practice in anesthesia and intensive care. "Blind" insertion represents the common conventional method and is associated with low first-pass success and frequent complications. This trial aimed to evaluate the novel gastric tube guide as a rigid conduit in regard to insertion success rate, time required and associated complications versus the conventional "blind" insertion method. We hypothesized that the insertion success rate is higher using the Orogastric tube guide. METHODS This trial was approved by ethics committee prior to patient recruitment. In a randomized order, anesthetists performed oral insertion of a gastri…