GLORIA

GEOMAR Library Ocean Research Information Access

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    In: The Lancet, Elsevier BV, Vol. 399, No. 10333 ( 2022-04), p. 1383-1390
    Type of Medium: Online Resource
    ISSN: 0140-6736
    RVK:
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 2067452-1
    detail.hit.zdb_id: 3306-6
    detail.hit.zdb_id: 1476593-7
    SSG: 5,21
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 2
    In: Journal of Cachexia, Sarcopenia and Muscle, Wiley, Vol. 12, No. 6 ( 2021-12), p. 1501-1512
    Abstract: Pulmonary arterial hypertension (PAH) is a progressive disease with limited survival. Iron deficiency (ID) correlates with disease severity and mortality. While oral iron supplementation was shown to be insufficient in such patients, the potential impact of parenteral iron on clinical measures warrants further investigation. Methods We retrospectively analysed the long‐term effects of intravenous ferric carboxymaltose (FCM) on iron status and clinical measures in patients with PAH and ID [ferritin  〈  100 μg/L or ferritin 100–300 μg/L and transferrin saturation (TSAT)  〈  20%] who were on stable targeted PAH therapy, compared with matched controls without ID. Patients with ID received a single infusion of FCM (500 to 1000 mg). Clinical measures monitored included exercise capacity, World Health Organization (WHO) functional class, ESC/ERS risk status, and hospitalizations. The observation period was up to 18 months. Results One hundred and seventeen patients (mean age 60.9 ± 16.1 years; 64.1% females) with confirmed PAH and on stable targeted therapy for ≥3 months were included (58 with and 59 patients without ID who did not receive FCM). In patients with ID, iron supplementation with FCM resulted in an immediate and sustained improvement of iron status for up to 18 months (serum iron, ferritin, TSAT, all P   〈  0.01). Fourteen patients in the FCM group received a second FCM infusion after 9.6 ± 4.8 months due to recurrent ID. At 6 and 18 months after FCM infusion, 6 min walk distance improved from 377.5 ± 15.9 at baseline to 412.5 ± 15.1 and 400.8 ± 14.5 m, respectively (both P   〈  0.05). WHO functional class ( P   〈  0.05) and ESC/ERS risk status also improved, and there was a reduction of hospitalizations for worsening PAH in the 12 months post vs. prior to iron repletion ( P  = 0.029). No significant changes were observed in the control group. FCM was well tolerated in all patients, with no severe adverse events. Conclusions In addition to targeted therapy, correction of ID by parenteral iron supplementation with FCM appears feasible and safe, has sustained effects on iron status, and may improve the clinical status and hospitalization rates in patients with PAH. Larger controlled studies are required to confirm this finding.
    Type of Medium: Online Resource
    ISSN: 2190-5991 , 2190-6009
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2586864-0
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 3
    In: npj Digital Medicine, Springer Science and Business Media LLC, Vol. 5, No. 1 ( 2022-06-28)
    Abstract: The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged 〉 55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with 〉 300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p  = 0.39). In patients with low baseline OACA ( 〈 90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p   〈  0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.
    Type of Medium: Online Resource
    ISSN: 2398-6352
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2925182-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 4
    In: International Journal of Population Data Science, Swansea University, Vol. 8, No. 1 ( 2023-10-02)
    Abstract: IntroductionIn randomised controlled trials (RCTs), bleeding outcomes are often assessed using definitions provided by the International Society on Thrombosis and Haemostasis (ISTH). Information relating to bleeding events in real-world evidence (RWE) sources are not identified using these definitions. To assist with accurate comparisons between clinical trials and real-world studies, algorithms are required for the identification of ISTH-defined bleeding events in RWE sources. ObjectivesTo present a novel algorithm to identify ISTH-defined major and clinically-relevant non-major (CRNM) bleeding events in a US Electronic Health Record (EHR) database. MethodsThe ISTH definition for major bleeding was divided into three subclauses: fatal bleeds, critical organ bleeds and symptomatic bleeds associated with haemoglobin reductions. Data elements from EHRs required to identify patients fulfilling these subclauses (algorithm components) were defined according to International Classification of Diseases, 9th and 10th Revisions, Clinical Modification disease codes that describe key bleeding events. Other data providing context to bleeding severity included in the algorithm were: `interaction type' (diagnosis in the inpatient or outpatient setting), `position' (primary/discharge or secondary diagnosis), haemoglobin values from laboratory tests, blood transfusion codes and mortality data. ResultsIn the final algorithm, the components were combined to align with the subclauses of ISTH definitions for major and CRNM bleeds. A matrix was proposed to guide identification of ISTH bleeding events in the EHR database. The matrix categorises bleeding events by combining data from algorithm components, including: diagnosis codes, 'interaction type', 'position', decreases in haemoglobin concentrations (≥2 g/dL over 48 hours) and mortality. ConclusionsThe novel algorithm proposed here identifies ISTH major and CRNM bleeding events that are commonly investigated in RCTs in a real-world EHR data source. This algorithm could facilitate comparison between the frequency of bleeding outcomes recorded in clinical trials and RWE. Validation of algorithm performance is in progress.
    Type of Medium: Online Resource
    ISSN: 2399-4908
    Language: Unknown
    Publisher: Swansea University
    Publication Date: 2023
    detail.hit.zdb_id: 2892786-2
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 5
    In: Digital Biomarkers, S. Karger AG, Vol. 4, No. 2 ( 2020-6-30), p. 45-59
    Abstract: 〈 b 〉 〈 i 〉 Aims: 〈 /i 〉 〈 /b 〉 Heart failure (HF) affects approximately 26 million people worldwide. With an aging global population, innovative approaches to HF evaluation and management are needed to cope with the worsening HF epidemic. The aim of the Real-Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF) study (NCT03507439) is to evaluate a composite instrument comprising remote, real-time, activity-monitoring devices combined with daily electronic patient-reported outcome (ePRO) items in patients who have been hospitalized for HF and are undergoing standard HF assessment (e.g., 6-min walking distance [6MWD], blood biomarkers, Kansas City Cardiomyopathy Questionnaire [KCCQ] , and echocardiography). 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 REALIsM-HF is an ongoing, 12-week, observational study enrolling 80–100 patients aged ≥45 years with HF with preserved ejection fraction (HFpEF; EF ≥45%) or reduced EF (HFrEF; EF ≤35%). Statistical analyses will include examining the association between data from wearables (the AVIVO 〈 sup 〉 © 〈 /sup 〉 mobile patient management patch or VitalPatch 〈 sup 〉 © 〈 /sup 〉 biosensor, and the DynaPort MoveMonitor 〈 sup 〉 © 〈 /sup 〉 ), daily ePROs, and conventional HF metrics (e.g., serum/plasma biomarkers, 6MWD, KCCQ, and echocardiographic parameters). The feasibility of and patient compliance with at-home devices will be documented, and the data captured for the purpose of establishing reference values in patients with HFpEF or HFrEF will be summarized. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 The REALIsM-HF study is to evaluate the longitudinal daily activity profiles of patients with HF and correlate these with changes in serum/plasma biomarker profiles, symptoms, quality of life, and cardiac function and morphology to inform the use of wearable activity monitors for developing novel therapies and managing patients.
    Type of Medium: Online Resource
    ISSN: 2504-110X
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2020
    detail.hit.zdb_id: 2906645-1
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...