Search results for "Baseline characteristics"
showing 10 items of 18 documents
Validation of a plasma metabolomics model that allows anticipation of the occurrence of cytomegalovirus DNAaemia in allogeneic stem cell transplant r…
2018
A plasma metabolomic model obtained by means of untargeted 1H nuclear magnetic resonance, to which taurine, choline, methylamine, total glutathione, trimethylamine N-oxide, lactate, lysine, isoleucine, total fatty acids and unsaturated fatty acids contributed, was validated for the prediction of first episodes of cytomegalovirus (CMV) DNAaemia in a cohort of 79 allogeneic stem haematopoietic stem cell transplant (allo-HSCT) recipients. The predictive success rate was nearly 65 % for patients at both low and high risk of CMV-related complications according to their baseline characteristics. Plasma metabolomics profiling shortly after engraftment (day 21 after transplantation) allowed the ant…
Updated Results from the German Mpnsg-0212 Combination Trial: Ruxolitinib Plus Pomalidomide in Myelofibrosis with Anemia
2019
Background: Anemia remains one cardinal symptom associated with reduced quality of life (QoL) in patients (pts) with myelofibrosis (MF) which is normally not being addressed by ruxolitinib (RUX). In our previous MPNSG-0109 trial, single-agent pomalidomide (POM) improved cytopenia in 14% (POM 0.5 mg QD) and 29% (POM 2.0 mg QD) of MF pts, respectively. In the MPNSG-0212 study, we sought to investigate the potential synergism of RUX plus POM to improve anemia and QoL in MF pts. Study Design: MPNSG-0212 is an ongoing multicenter, open-label, single-arm phase-Ib/II trial with a target population of 90 pts following a two-stage design (NCT01644110). Pts 1-40 in cohort 1 (co1) were treated with RU…
Growth hormone replacement in adults:Real-world data from two large studies in US and Europe
2020
Objective: This report describes the effectiveness and safety of growth hormone replacement in 3180 adult patients with growth hormone deficiency followed-up for 0.0–12.2 years in two completed, complementary, non-interventional, multicentre studies, NordiNet® International Outcome Study (IOS) (NCT00960128) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program (NCT01009905). Design: In both studies, Norditropin® (somatropin; Novo Nordisk A/S, Denmark) was administered at the discretion of the treating physician and according to routine practice. We present data on baseline characteristics, growth hormone dose, safety data and change from baseline in waist circumferenc…
Web Support for weight-loss interventions: PREDIRCAM2 clinical trial baseline characteristics and preliminary results
2018
An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One…
Do all people with schizophrenia receive the same benefit from different family intervention programs?
2005
The study evaluated baseline characteristics that could be used to predict the outcome of family intervention in schizophrenia and focussed on identifying the subgroups of patients who were more likely to respond to one therapeutic modality than another. We conducted a controlled trial in which participants were assigned at random to either a Behavioral Family Intervention Group or a Relatives' Group. Patients in one catchment area, having suffered one psychotic relapse within the previous year and living with their families, were assessed by an independent evaluator at baseline and 12 months later. Some clinical and family factors such as the duration of illness, number of hospital admissi…
Rationale, design and baseline characteristics of the MyoVasc study: A prospective cohort study investigating development and progression of heart fa…
2020
Abstract Background Heart failure (HF) is a poly-aetiological syndrome with large heterogeneity regarding clinical presentation, pathophysiology, clinical outcome and response to therapy. The MyoVasc study (NCT04064450) is an epidemiological cohort study investigating the development and progression of HF. Methods The primary objective of the study is (a) to improve the understanding of the pathomechanisms of HF across the full spectrum of clinical presentation, (b) to investigate the current clinical classifications of HF, and (c) to identify and characterize homogeneous subgroups regarding disease development using a systems-oriented approach. Worsening of HF, that is, the composite of tr…
Design and Baseline Characteristics of the HELP Study: An Extended and Long-Term Observation of Pathological Myopia in Caucasians.
2017
<b><i>Purpose:</i></b> To assess the natural disease progression of high myopia in Caucasians considered at risk for the development of myopic choroidal neovascularization (mCNV). <b><i>Methods:</i></b> Subjects were recruited in 25 clinical sites between June 2014 and June 2016. Main inclusion criteria included axial length of ≥26 mm, best-corrected visual acuity ≥0.05 decimal equivalent and presence of at least one out of five predefined morphological disease risk criteria. These were (1) subfoveal choroidal thinning &#x3c; 50 µm, (2) enhanced choroidal curvature length &#x3e; 6,300 µm, (3) lacquer cracks, (4) patchy atrophy &#x3…
Efficacy of the treatment with prostaglandin E-1 in venous ulcers of the lower limbs.
2005
Background. Venous ulcers represent an important medical problem due to their high prevalence and consequent sanitary costs. In this study we evaluated the effect of Prostaglandin E-1 (PGE-1), a drug that improves district ischemia, on the healing of venous ulcers. Methods. We performed a randomized, placebo-controlled, single blind study, in which 87 patients, carriers of venous leg ulcers, homogeneous for dimensions and characteristics, were treated for 20 days an with infusion of Prostaglandin E-1 or placebo, in association with a topic therapy. The dimension and the number of the ulcers were determined at the beginning of the treatment and then every 20 days up to 4 months or until tota…
Surveillance as determinant of long-term survival in non-transplanted hepatocellular carcinoma patients
2021
Purpose: We aimed at assessing the impact of surveillance on long-term survival in HCC patients. Methods: From the ITA.LI.CA database, we selected 1028 cases with long (≥5 years, LS group) and 2721 controls with short-term survival (<
Estrategia de revascularización invasiva en el síndrome coronario sin elevación del segmento ST. El debate continúa
2009
Revascularization strategy in the setting of non-ST-segment acute coronary syndromes remains a controversy. Evidence obtained from clinical trials, generally performed in selected patients, reveals heterogeneous and insufficient results when a routine invasive revascularization strategy and a conservative one are compared. The conflicting results among trials are due to differences in: a) baseline characteristics; b) methodology and protocols applied and; c) objectives and outcomes definitions. Although present guidelines recommend that a routine invasive strategy should be used in high risk non-ST-segment elevation acute coronary syndromes, there is no consistent evidence that supports thi…