There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 14 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.

开始日期2024-09-01

申办/合作机构

Ziekenhuis Netwerk Antwerpen

[+7]

NCT06175208 / Enrolling by invitationN/A

Targeting Fear of Cancer Recurrence in Cancer Survivors: a Multicentre Randomized Controlled Trial to Evaluate Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies

In this trial, the investigators introduce two internet-based psychological methods to meet the currently unmet medical need to cope with Fear of Cancer Recurrence (FCR) beyond the acute phase of cancer treatment: internet-based emotional freedom techniques (iEFT) and internet-based mindfulness intervention (iMMI). The primary aim of this trial is to examine the efficacy of Internet-Based Emotional Freedom Techniques (iEFT) and Internet-Based Mindfulness Meditation Intervention (iMMI) to alleviate Fear of Cancer Recurrence (FCR) in cancer survivors, as determined through the Fear of Cancer Recurrence Inventory (FCRI) in cancer survivors. To translate a statistically significant effect on FCR into a clinically significant change, the investigators would need to detect a between-group difference in mean FCRI at T1 of 10 points using an independent samples t-test (two experimental groups are compared against a single wait-list control). When the application of iEFT and/or iMMI appears effective to reduce FCR, these self-help methods could be implemented in clinical settings. The use of these low cost interventions with a low threshold, by an internet-based approach, will facilitate a potential implementation in clinical practice.

开始日期2024-07-03

申办/合作机构

Algemeen Ziekenhuis Groeninge VZW

[+4]

NCT05423808 / WithdrawnN/AIIT

Streamlined Geriatric and Oncological Evaluation Based on IC Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients. TWOBE Study

The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals.

开始日期2024-06-01

申办/合作机构

University College Dublin

[+11]

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328

项与 Algemeen Ziekenhuis Groeninge VZW 相关的文献（医药）

2024-05-01·Journal of Diabetes Science and Technology

The Impact of Baseline User Characteristics on the Benefits of Real-Time Versus Intermittently Scanned Continuous Glucose Monitoring in Adults With Type 1 Diabetes: Moderator Analyses of the ALERTT1 Trial

Article

作者: Nobels, Frank ; Vanhaverbeke, Gerd ; Myngheer, Nele ; Van Huffel, Liesbeth ; Maes, Toon ; Visser, Margaretha Martha ; Keymeulen, Bart ; Charleer, Sara ; Dirinck, Eveline ; Vercammen, Chris ; De Block, Christophe ; Mathieu, Chantal ; Gillard, Pieter ; Fieuws, Steffen ; Hilbrands, Robert

Background: ALERTT1 showed that switching from intermittently scanned continuous glucose monitoring (isCGM) without alerts to real-time CGM (rtCGM) with alert functionality improved time in range (TIR; 70-180 mg/dL), glycated hemoglobin (HbA1c), time <54 mg/dL, and Hypoglycemia Fear Survey version II worry subscale (HFS-worry) score after six months in adults with type 1 diabetes (T1D). Moderator analyses aimed to identify certain subgroups that would benefit more from switching to rtCGM than others. Methods: Post hoc analyses of ALERTT1 evaluated the impact of 14 baseline characteristics on the difference (delta) in mean TIR, HbA1c, time <54 mg/dL, and HFS-worry score at six months between rtCGM and isCGM. Therefore, the delta was allowed to depend on each of these variables by including interactions in the moderator analysis model. Analyses were performed separately for each variable; variables with P < .10 in the univariable analysis were combined into a single model. Results: Univariable analyses showed no dependency of delta TIR, HbA1c, or time <54 mg/dL on variables other than CGM type. Only delta HFS-worry score depended on baseline HbA1c ( P = .0059), indicating less worries with rtCGM in people with baseline HbA1c <6.5% or ≥8%. Given P < .10 for dependency of delta TIR on insulin therapy type (favoring multiple daily injections), baseline HbA1c, and baseline TIR, these variables were combined into a multivariable analysis; interactions were not statistically significant. Conclusions: Except for HFS-worry score, no interactions between 14 baseline characteristics and the six-month intervention effect of rtCGM on TIR, HbA1c, or time <54 mg/dL were observed, supporting the conclusion of ALERTT1 that switching from isCGM without alerts to rtCGM with alert functionality is beneficial for a wide range of people with T1D.

2024-05-01·The Journal of Pathology: Clinical Research

Recurrent and novel fusions detected by targeted RNA sequencing as part of the diagnostic workflow of soft tissue and bone tumours

Article

作者: Wafa, Hazem ; Vander Borght, Sara ; Deraedt, Karen ; Libbrecht, Louis ; Renard, Marleen ; van den Hout, Mari Fcm ; Hompes, Daphne ; De Roo, An-Katrien ; Bourgain, Claire ; Vanden Bempt, Isabelle ; Mazzeo, Filomena ; Sciot, Raphael ; Zago Baltazar, Rafael ; Spans, Lien ; van Marcke, Cédric ; Vernemmen, Astrid ; Schöffski, Patrick ; Claerhout, Sofie ; Sinnaeve, Friedl

AbstractThe identification of gene fusions has become an integral part of soft tissue and bone tumour diagnosis. We investigated the added value of targeted RNA‐based sequencing (targeted RNA‐seq, Archer FusionPlex) to our current molecular diagnostic workflow of these tumours, which is based on fluorescence in situ hybridisation (FISH) for the detection of gene fusions using 25 probes. In a series of 131 diagnostic samples targeted RNA‐seq identified a gene fusion, BCOR internal tandem duplication or ALK deletion in 47 cases (35.9%). For 74 cases, encompassing 137 FISH analyses, concordance between FISH and targeted RNA‐seq was evaluated. A positive or negative FISH result was confirmed by targeted RNA‐seq in 27 out of 49 (55.1%) and 81 out of 88 (92.0%) analyses, respectively. While negative concordance was high, targeted RNA‐seq identified a canonical gene fusion in seven cases despite a negative FISH result. The 22 discordant FISH‐positive analyses showed a lower percentage of rearrangement‐positive nuclei (range 15–41%) compared to the concordant FISH‐positive analyses (>41% of nuclei in 88.9% of cases). Six FISH analyses (in four cases) were finally considered false positive based on histological and targeted RNA‐seq findings. For the EWSR1 FISH probe, we observed a gene‐dependent disparity (p = 0.0020), with 8 out of 35 cases showing a discordance between FISH and targeted RNA‐seq (22.9%). This study demonstrates an added value of targeted RNA‐seq to our current diagnostic workflow of soft tissue and bone tumours in 19 out of 131 cases (14.5%), which we categorised as altered diagnosis (3 cases), added precision (6 cases), or augmented spectrum (10 cases). In the latter subgroup, four novel fusion transcripts were found for which the clinical relevance remains unclear: NAB2::NCOA2, YAP1::NUTM2B, HSPA8::BRAF, and PDE2A::PLAG1. Overall, targeted RNA‐seq has proven extremely valuable in the diagnostic workflow of soft tissue and bone tumours.

2024-02-01·Cancer Communications

Association of previously irradiated stable brain metastases with outcomes of atezolizumab‐treated non‐small cell lung cancer: A pooled analysis of individual patient data from three randomized trials

Article

作者: Jing-Ching Wu, Abraham ; Bourbonne, Vincent ; Wang, Zezhou ; Zhou, Yue ; Sundahl, Nora ; Guo, Tiantian ; Zhu, Zhengfei ; Ni, Jianjiao ; Käsmann, Lukas ; Liang, Fei

项与 Algemeen Ziekenhuis Groeninge VZW 相关的新闻（医药）

2021-02-25

·Endpoints

Dutch biotech Intravacc seeks to bolster Netherlands vaccine manufacturing abilities with new plants

The pandemic has given a huge edge to any country that can produce vaccine in its borders. Now one vaccine biotech is looking to make sure their country has that edge for any future pandemic. Arguing Covid-19 exposed the Netherlands’ “vulnerability,” Dutch vaccines company Intravacc recently announced that its new “modern pilot production plant” will soon be functional and that it’s spearheading a conglomerate designing a multipurpose vaccine production plant. In future medical emergencies, the company hopes that such a plant will make the Netherlands far less reliant on foreign vaccine production than the country has been during the ongoing pandemic. The pilot production plant, Intravacc said in a press release , will officially launch in the second quarter of 2021 (which begins in April), and is equipped with GMP manufacturing conditions to produce candidate vaccines for Phase I and II studies. The multipurpose plant has broad purposes, says Intravacc CEO Jan Groen. The company hopes the site will bring new companies aboard and promote stable job growth in the Netherlands, in addition to offer protection against future pandemics. The facility, acronymed MPVPP, will be designed to produce between 40 and 200 million doses per year, the company said, and be suitable for the formulation and actual production of vaccines, as well as for filling and packaging vaccine vials. “A new and state-of-the-art MPVPP facility, in combination with the now almost completed pilot plant, would make the Netherlands much less dependent on foreign vaccine production in the event of a future pandemic,” Groen said. The Dutch vaccines company in September also landed an up to $9.4 million contract from NIAID to develop a vaccine for enterovirus D68, a respiratory virus that can cause paralysis.

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