Search results for "Clinical Investigations"
showing 10 items of 14 documents
Measurement of Fractional Exhaled Nitric Oxide: Comparison of Three Different Analysers
2019
<b><i>Background:</i></b> Fractional exhaled nitric oxide (FeNO) is a surrogate marker for airway inflammation, supporting the diagnostic pathway and treatment decisions for asthma patients. <b><i>Objectives:</i></b> Aim of this study was to compare the new analyser Vivatmo pro (Bosch, BV) with NIOX VERO (Circassia, CN) and CLD (Ecomedics, EC). <b><i>Methods:</i></b> In 100 asthmatics (median 53 years [range 20–87], 62% female, 86% on inhaled corticosteroids [mean 1,300 μg beclomethasone dipropionate or equivalent], 35% treated with biologics) 2 FeNO measurements per device were performed. Additionally, the success rate…
Safety and efficacy of left atrial appendage occlusion with the ACP or Watchman device guided by intracardiac echocardiography from the left atrium
2021
Abstract Background There is a paucity of randomized data regarding the safety and efficacy of the use of intracardiac echocardiography (ICE) from the left atrium (LA) to guide left atrial appendage occlusion (LAAO) procedures under local anesthesia using either of the available devices. Hypothesis The aim of this study was to compare the efficacy and safety of ICE from the LA with transesophageal echocardiography (TEE) for guidance during transcatheter LAAO procedures. Methods Single‐center, cohort study of patients undergoing LAAO with the Amplatzer Cardiac Plug or Watchman device. Procedures were guided by ICE from the LA with local anesthesia (n = 175) or TEE under general anesthesia (n…
Comparison between zofenopril and ramipril in combination with acetylsalicylic acid in patients with left ventricular systolic dysfunction after acut…
2012
Background: Angiotensin-converting enzyme inhibitors (ACEIs) are largely employed for treating patients with left ventricular dysfunction (LVD), but their efficacy may be negatively affected by concomitant administration of acetylsalicylic acid (ASA), with some difference among the different compounds. Hypothesis: The interaction between ASA and the two ACEIs zofenopril and ramipril may result in a different impact on survival of cardiac patients, due to differences in the pharmacological properties of the two ACEIs. Methods: This phase IIIb, randomized, double-blind, parallel-group, multicenter, European study compared the safety and efficacy of zofenopril (60 mg/day) and ramipril (10 mg/d…
Treatment of early childhood medulloblastoma by postoperative chemotherapy and deferred radiotherapy
2008
To investigate the utility of postoperative chemotherapy in delaying radiotherapy and to identify prognostic factors in early childhood medulloblastoma, we studied children younger than 3 years of age registered to the HIT-SKK'87 (Therapieprotokoll für Säuglinge und Kleinkinder mit Hirntumoren [Brain Tumor Radiotherapy for Infants and Toddlers with Medulloblastoma] 1987) trial who received systemic interval chemotherapy until craniospinal radiotherapy was applied at 3 years of age or at relapse, from 1987 to 1993. Children with postoperative residual tumor or metastatic disease received systemic induction chemotherapy prior to interval chemotherapy. Twenty-nine children were eligible for an…
Longitudinal Association Between Physical Activity and Frailty Among Community-Dwelling Older Adults
2020
Objectives: To examine the longitudinal association between frequency of moderate physical activity (PA) and overall, physical, psychological, and social frailty among community-dwelling older adults older than 70 years. Second, we assessed the association between a 12-month change in frequency of moderate PA and frailty. Design: Longitudinal cohort study. Setting: Community settings in Spain, Greece, Croatia, the Netherlands, and the United Kingdom. Participants: A total of 1735 participants (61.1% female ; mean age = 79.6 years ; SD = 5.5 years). Measurements: The frequency of self-reported moderate PA was measured and classified into two categories: "regular frequency" and "low frequency…
Spontaneous Breathing in Early Acute Respiratory Distress Syndrome
2019
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Differential Prognostic Effect of Revascularization According to a Simple Comorbidity Index in High-Risk Non-ST-Segment Elevation Acute Coronary Synd…
2011
Background: Data on the effect of revascularization on outcome in patients with high-risk non–ST-segment elevation acute coronary syndrome (NSTEACS) and significant comorbidities are scarce. Recently, a simple comorbidity index (SCI) including 5 comorbidities (renal failure, dementia, peripheral artery disease, heart failure, and prior myocardial infarction [MI]) has shown to be a useful tool for risk stratification. Nevertheless, therapeutic implications have not been derived. Hypothesis: We sought to evaluate the prognostic effect attributable to revascularization in NSTEACS according the SCI score. Methods: We included 1017 consecutive patients with NSTEACS. The effect of revascularizati…
Early effects of empagliflozin on exercise tolerance in patients with heart failure: A pilot study
2018
BackgroundSodium-glucose linked transporter 2 inhibition recently emerged as a promising therapy for reducing the risk of heart failure (HF) in patients with type 2 diabetes mellitus (T2DM). However, there is a lack of data endorsing its role in symptomatic HF patients. We sought to evaluate the short-term effects of empagliflozin on maximal exercise capacity in these patients. HypothesisWe postulate tretament with empagliflozin may improve functional capacity in patients with T2DM and established HF. MethodsNineteen T2DM patients with symptomatic HF were prospectively included and underwent cardiopulmonary exercise testing before and 30days after initiation of empagliflozin therapy. A mixe…
Treatment of embryonal tumors with multilayered rosettes with carboplatin/etoposide induction and high-dose chemotherapy within the prospective P-HIT…
2021
Abstract Background Embryonal tumors with multilayered rosettes (ETMR) are highly aggressive tumors occurring in early childhood. Published clinical data refer to retrospective, heterogeneously treated cohorts. Here, we describe the outcome of patients treated according to the prospective P-HIT trial and subsequent HIT2000-interim-registry. Patients and methods Age-stratified treatment included carboplatin/etoposide induction, tandem high-dose chemotherapy (“CARBO/ETO + HDCT”), and response-stratified radiotherapy. Patients with centrally reviewed neuropathological and molecularly confirmed diagnosis of ETMR recruited within the P-HIT trial (2001-2011; n = 19), the HIT2000-interim-registry …
Phase II study of irinotecan in combination with temozolomide (TEMIRI) in children with recurrent or refractory medulloblastoma: a joint ITCC and SIO…
2013
BackgroundThis multicenter phase II study investigated temozolomide + irinotecan (TEMIRI) treatment in children with relapsed or refractory medulloblastoma.MethodsPatients received temozolomide 100–125 mg/m2/day (days 1–5) and irinotecan 10 mg/m2/day (days 1–5 and 8–12) every 3 weeks. The primary endpoint was tumor response within the first 4 cycles confirmed ≥4 weeks and assessed by an external response review committee (ERRC). In a 2-stage Optimum Simon design, ≥6 responses in the first 15 evaluable patients were required within the first 4 cycles for continued enrollment; a total of 19 responses from the first 46 evaluable patients was considered successful.ResultsSixty-six patients were…