Search results for "endpoint"
showing 10 items of 437 documents
Surrogate outcomes and transportability
2019
Identification of causal effects is one of the most fundamental tasks of causal inference. We consider an identifiability problem where some experimental and observational data are available but neither data alone is sufficient for the identification of the causal effect of interest. Instead of the outcome of interest, surrogate outcomes are measured in the experiments. This problem is a generalization of identifiability using surrogate experiments and we label it as surrogate outcome identifiability. We show that the concept of transportability provides a sufficient criteria for determining surrogate outcome identifiability for a large class of queries.
Recent European Food Safety Authority toxicological evaluations of major phthalates used in food contact materials
2009
During the 1980s and 1990s, and at the EU level, the Scientific Committee for Food evaluated a number of phthalates that were being used, or were requested for use, as additives in plastics. At this time, peroxisome proliferation was considered as the pivotal effect on which toxicological evaluation of these chemicals was based. At the end of 1990s, a general consensus has been agreed that rodents are highly sensitive to the phenomenon of peroxisome proliferation and that this particular effect should not be used for human risk assessment. Consequently in 2004, it was requested from the newly created European Food Safety Authority to perform a new evaluation of the mainly used phthalates on…
Procalcitonin as a marker of Candida species detection by blood culture and polymerase chain reaction in septic patients
2014
Background: The aim of our study is to test procalcitonin (PCT) as surrogate marker of identification of Candida spp. by blood culture (BC) and real-time-polymerase chain reaction (PCR), whether alone or in association with bacteria, in septic patients.Methods: We performed a single-centre retrospective study. We reviewed the clinical charts of patients with a diagnosis of severe sepsis or septic shock treated at our general intensive care unit from March 2009 to March 2013. We analysed all diagnostic episodes consisting of BC, real-time PCR assay and dosage of PCT. We registered age, sex, white blood count, sequential organ failure assessment score and type of admission between medical or …
A Prospective Open‐Label Observational Study of a Buffered Soluble 70 mg Alendronate Effervescent Tablet on Upper Gastrointestinal Safety and Medicat…
2021
Upper gastrointestinal (GI) side effects are a main reason for discontinuing bisphosphonate treatment, an important therapeutic option for osteoporosis patients. Consequently, the development of novel formulations with improved tolerability is warranted. In this multicenter prospective, observational, postauthorization safety study conducted in Italy and Spain, postmenopausal women (PMW) with osteoporosis (naïve to bisphosphonates) were treated weekly with a buffered soluble alendronate 70 mg effervescent (ALN-EFF) tablet (Binosto®) and followed for 12 ± 3 months. Information was collected on adverse events (AEs), medication errors, persistence, and compliance using the Morisky-Green questi…
Kinetics of cytomegalovirus (CMV) pp65 and IE-1-specific IFNgamma CD8+ and CD4+ T cells during episodes of viral DNAemia in allogeneic stem cell tran…
2010
The dynamics of CMV pp65 and IE-1-specific IFNgamma-producing CD8(+) (IFNgamma CD8(+)) and CD4(+) (IFNgamma CD4(+)) T cells and CMV DNAemia were assessed in 19 pre-emptively treated episodes of active CMV infection. Peripheral counts of IFNgamma CD8(+) and IFNgamma CD4(+) T cells inversely correlated with CMV DNAemia levels (P = <0.001 and P = 0.003, respectively). A threshold value of 1.3 cells/microl predicting CMV DNAemia clearance was established for IFNgamma CD8(+) T cells (PPV, 100%; NPV, 93%) and for IFNgamma CD4(+) T cells (PPV, 100%; NPV, 75%). Undetectable T-cell responses were usually observed at the time of initiation of pre-emptive therapy. Either a rapid (within 7 days) or a d…
Prognostic Value of Geriatric Conditions Beyond Age After Acute Coronary Syndrome
2016
The aim of the present study was to investigate the prognostic value of geriatric conditions beyond age after acute coronary syndrome. This was a prospective cohort design including 342 patients (from October 1, 2010, to February 1, 2012) hospitalized for acute coronary syndrome, older than 65 years, in whom 5 geriatric conditions were evaluated at discharge: frailty (Fried and Green scales), comorbidity (Charlson and simple comorbidity indexes), cognitive impairment (Pfeiffer test), physical disability (Barthel index), and instrumental disability (Lawton-Brody scale). The primary end point was all-cause mortality. The median follow-up for the entire population was 4.7 years (range, 3-2178 …
Repetitive use of LEvosimendan in Ambulatory Heart Failure patients (LEIA-HF) - The rationale and study design
2022
Abstract Purpose Clinical practice forces the necessity to conduct a clinical trial concerning the group of outpatients with chronically advanced heart failure in III or IV NYHA functional class, frequently requiring hospitalizations due to HF exacerbation, and often left without any additional therapeutic option. The current trial aims to determine the efficacy and safety of repeated levosimendan infusions in the group of severe outpatients with reduced ejection fraction (HFrEF). Material and methods LEIA-HF (LEvosimendan In Ambulatory Heart Failure Patients) is a multicentre, randomized, double-blind, placebo-controlled, phase 4 clinical trial to determine whether the repetitive use of le…
EFFICACY AND SAFETY OF OZONE THERAPY FOR PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER, RANDOMIZED CLINICAL TRIAL
2018
Background. Ozone therapy has a long history. Some studies proved that ozone therapy was useful in treatment of virus hepatitis. Objective: To evaluate the efficacy and safety of new medical ozone therapy system for the treatment of chronic hepatitis B. Method. One hundred eighty-nine patients with chronic hepatitis B were included in this open-label, phase 3 study, and randomly assigned to receive ozone autohemotherapy with experimental ozone generator TianYi (group 1) or with ozone generator Humares (group 2) or oral diammonium glycyrrhizinate capsules (group 3) in a 1:1:1 ratio for 12 weeks. The primary efficacy end point was sera HBV DNA level of less than 1×103 IU/ml or having a more t…
Early and midterm outcomes of bioresorbable vascular scaffolds for ostial coronary lesions: insights from the GHOST-EU registry.
2016
Aims: We aimed to investigate the outcomes of bioresorbable vascular scaffolds (BVS) in coronary ostial lesions. Ostial lesions represent a challenging angiographic subset, with higher event rates compared with non-ostial lesions. BVS might be associated with advantages over the long term, but their safety in this setting remains to be explored. Methods and results: Procedural and 12-month follow-up data from consecutive patients treated with BVS for lesions located at the ostium of the right (RCA), left anterior (LAD) or circumflex (LCX) coronary in 11 European centres were collected. The primary device-oriented endpoint was defined as a combination of cardiovascular death, target vessel m…
Laparoscopic distal pancreatectomy: what factors are related to the learning curve?
2014
none 7 no PURPOSE: The factors related to the learning curve for laparoscopic distal pancreatectomy have rarely been evaluated. METHODS: A retrospective study of 32 patients who underwent a laparoscopic distal pancreatectomy performed at a high-volume center by a single pancreatic surgeon experienced with laparoscopic surgery was conducted. Pre-, intra- and postoperative data were collected. The primary endpoint was the length of the operation. The secondary endpoints were the conversion and reoperation rates, overall postoperative morbidity and mortality rates, the length of hospital stay and rate of unplanned splenectomy. RESULTS: The length of the operation and the cumulative sum of the …