Search results for "Interim analysis"

TCT-663 Comparison of Conformability and Wall Shear Stress Between Resolute Integrity Zotarolimus-Eluting Stent and the XIENCE Xpedition Everolimus-E…

2018

Given its continuous wire molding and sinusoidal design, we hypothesized that Resolute Integrity stent (R-ZES) is more conformable than the XIENCE Xpedition stent (X-EES) and therefore may induce more physiologic wall shear stress (WSS) in angulated coronary arteries. Interim analysis of

Relationship between sleep disturbances and peripheral airway abnormalities in COPD patients

2017

Background: Individuals with COPD experience sleep disturbances due to the impact of symptoms on quality of sleep. Aim: To test the hypothesis that, in COPD, sleep disturbances are linked to peripheral airway abnormalities. Methods: An investigational study is being performed at the University of Palermo, Italy. The impact of breathing problems on quality of sleep during the previous week is measured with the COPD and Asthma Sleep Impact Scale (CASIS) questionnaire. Airway resistances by impulse oscillometry (IOS) assesses peripheral airway abnormalities. Lung function evaluation includes static and dynamic lung volume measurements. To rule out the risk of having obstructive sleep apnea, th…

OSACO: an observational study in asthma-COPD overlap syndrome (ACOS)

2017

Background: ACOS describes the co-occurrence of asthma and COPD, although its prevalence and clinical features remain poorly characterized. Aims: To better understand the prevalence and characteristics of ACOS. Methods: An observational study is being performed in subjects with bronchial obstruction at 3 Italian centers. In the first phase, consecutive patients ≥40 years with documented bronchial obstruction are being recruited; eligible patients will enter the second phase, consisting of imaging, functional and clinical evaluation with the MRC dyspnea scale, St. George9s respiratory questionnaire index, Charlson index, and skin prick test. Main inclusion criteria for the evaluation phase a…

Long-term use of human albumin for the treatment of ascites in patients with hepatic cirrhosis: The interim analysis of the ANSWER study

2015

s / Digestive and Liver Disease 47S (2015) e1–e18 e7 (months; 95% CI): CPT 0 62 (52.9–71.1), A 44 (41.6–46.4), B 22 (19.7–24.3), C 9 (6.6–11.3), p<0.0001. Comparisons between survivals of CTP 0 vs A, B and C were also statistically different (p<0.0001 in all associations). The prognosis of patients in the intermediateBCLCstagealsodifferedaccording to the liver function (0 vs A vs B, p<0.0001). Conclusions: The newly proposed CTP class 0 identifies a different subgroup of patientswith a better prognosis, alsowhen applied in a European cohort, where HCV aetiology is predominant. This new approach impacts not only on outcome prediction but also, potentially, on treatment allocation, better str…

Entecavir effectiveness in naïve and NUC experienced patients: Interim analysis of the ENTAS cohort study of patients with chronic hepatitis B

2014

Alpha-dihydroergocryptine in the treatment of de novo parkinsonian patients: results ofa multicentre, randomized, double-blind, placebo-controlled st…

2000

INTRODUCTION A multicentre, randomized, double-blind, placebo-controlled, parallel group study was carried out in 123 patients suffering from never treated (de novo) idiopathic Parkinson's disease (PD). The aim of the study was to confirm the efficiency and safety of alpha-dihydroergocryptine (alpha-DHEC) given as monotherapy in the symptomatic treatment of PD. The total score of the Unified Parkinson's Disease Rating Scale (UPDRS) was identified as the efficacy target variable. PATIENTS AND METHODS Sixty-two patients (32 males, 30 females, mean age +/- SD 64 +/- 10) were randomized to alpha-dihydroergocryptine and 61 (30 males, 31 females, mean age 63.8 +/- 9.1) to placebo. According to th…

Tu1253 How Safe Is Sedation in Gastrointestinal Endoscopy? a Prospective Multicenter Trial: an Interim Analysis of 73,941 Endoscopies. Data From Pros…

2013

were those plausibly associated with the procedure and severe enough for the patient to seek medical attention. We compared the proportion of patients with adverse events associated with gastrointestinal endoscopy identified with direct patient contact to the proportion identified through our current infrastructure using the chi-square statistic. Results: During the study period, 11,710 endoscopic procedures were performed on 9,683 patients. Our study personnel made 3205 calls over a three month period and ultimately made contact with 1999 (17%; 84.5% of those called) patients. 28 (1.4%) adverse events were identified through direct patient contact. Our adverse event tracking infrastructure…

Sustained Responses and Resistance to Imatinib Mesylate in the First 173 Chronic Myeloid Leukemia Patients Accrued by the SCREEN Multicenter Study: F…

2009

Abstract Abstract 4276 Introduction Imatinib mesylate (IM) has shown unprecedented effectiveness in the treatment of Chronic Myeloid Leukemia (CML) patients (pts) in the chronic phase of the disease. As most of the data concerning the efficacy of the drug derive either from a single sponsored trial or from single institution reports, we decided to accrue all CML pts diagnosed in the Italian region of Sicily to the observational SCREEN (Siciliy CML Regional Enterprise) study, to evaluate the hematological, cytogenetic and molecular responses of this unselected population to IM. Patients and Methods Although the study is still ongoing, 173 consecutive CML pts have been enrolled between Januar…

Treatment-resistant depression in a real-world setting: first interim analysis of characteristics, healthcare resource use, and utility values of the…

2020

Background: Major depressive disorder (MDD) is among the most common psychiatric disorders. One-third of patients are usually unresponsive to several lines of treatment. This study aimed to describe the FondaMental French cohort of patients with treatment-resistant depression (TRD) and to estimate utility and healthcare resource use outcomes. Methods: Patients with TRD were evaluated prospectively over four years (baseline, 6, 12, 18, 24, 36 and 48 months) in a real-world clinical setting. Interim analyses focused on the first two consecutive years. Four MDD-related states (major depressive episode (MDE), response, remission, recovery) were defined based on the MADRS (Montgomery&ndash