The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.
To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.
Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months after the initial tACS session.

Start Date24 Apr 2024

Sponsor / Collaborator

HagaZiekenhuis

[+1]

NCT06082492 / RecruitingNot ApplicableIIT

The Beneficial Value of 18F FDG PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients: the NVALT31-PET Study

The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F-Fluorodeoxyglucose Positron Emission Tomography/ Computerized Tomography (18F FDG PET/CT) versus follow-up with conventional CT surveillance.
Participants will receive usual care until 3 years of follow-up (control group) with additional whole-body 18F FDG PET/CT scans during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up in the intervention group.
Other tasks include:
filling in quality of life (QOL) questionnaires at every time point;
participating in an interview evaluating the addition of the 18F FDG PET/CT scans (optional);
collecting blood at the follow-up time points for our secondary endpoint (optional).
Researchers will compare the usual care control group with the intervention group to see if the additional 18F FDG PET/CT scans are (cost)-effective.

Start Date19 Mar 2024

Sponsor / Collaborator

Radboud University Medical Center

[+17]

100 Clinical Results associated with HagaZiekenhuis

0 Patents (Medical) associated with HagaZiekenhuis

660

Literatures (Medical) associated with HagaZiekenhuis

01 Aug 2024·Journal of the American Academy of Dermatology

Dupilumab provides sustained effectiveness on patient-reported outcomes and favorable safety in patients with moderate-to-severe atopic dermatitis: Up to 5-year results from the daily practice BioDay registry

Article

Author: Schuttelaar, Marie-Louise A ; Haeck, Inge ; Oosting, Albert J ; Dekkers, Coco C ; de Bruin-Weller, Marjolein S ; de Graaf, Marlies ; Nijssen, Annieke ; Christoffers, Wianda A ; Tupker, Ron A ; Kamsteeg, Marijke ; Flinterman, Annebeth ; Boesjes, Celeste M ; Zhang, Junfen ; Kamphuis, Esmé ; van der Gang, Lian F ; Loman, Laura ; Politiek, Klaziena ; van der Rijst, Lisa P ; Touwslager, Wouter R H ; Spekhorst, Lotte S ; Stewart, Shiarra M ; Romeijn, Margreet L E ; van Lynden-van Nes, Anneke M T ; van Lumig, Paula

BACKGROUNDLong-term daily practice data on patient-reported benefits of dupilumab for atopic dermatitis (AD) remains limited.OBJECTIVETo evaluate patient-reported outcome measures (PROMs) and the safety of dupilumab in patients with moderate-to-severe AD over a follow-up period of up to 5 years.METHODSData were extracted from the prospective, multicenter BioDay registry (October 2017-2022) of patients with moderate-to-severe AD treated with dupilumab in daily practice.RESULTSIn total 1223 patients, 1108 adults and 115 pediatric patients were included. After ≥1 year of treatment, mean Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), Numeric rating scale (NRS)-pruritus ranged between 7.8 and 8.7, 3.5 and 4.2, and 2.9 and 3.1 in adults, respectively, whilst these patient-reported outcome measures (PROMs) ranged between 8.9 and 10.9, 4.4 and 6.4, and 3.0 and 3.7 in pediatric patients, respectively. At follow-up, overall work impairment decreased from 40.1% to 16.3% to 13.3% in adults. Furthermore, class I obesity and itch-dominant patients generally had less favorable treatment response. Of all patients, 66.8% reported ≥1 adverse event, with conjunctivitis being the most common (33.7%).LIMITATIONSThe overall percentage of missing values for selected PROMs was 26% in adults and 46% in pediatric patients.CONCLUSIONIn addition to favorable safety, dupilumab has demonstrated sustained effectiveness across various PROMs, underscoring the treatment benefits from patients' perspectives.

01 Jul 2024·European Journal of Vascular and Endovascular Surgery

Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry

Article

Author: Mees, Barend M E ; Cuypers, Philippe W M ; Schelzig, Hubert ; van Basten Batenburg, Michiel ; Lauwers, Geert ; Scheinert, Dierk ; Verhoeven, Eric ; Rouhani, Guido ; Van den Eynde, Wouter ; Vermassen, Frank ; Kölbel, Tilo ; Yeung, Kak K ; Wever, Jan J ; Fioole, Bram ; Hatzl, Johannes ; Böckler, Dittmar

OBJECTIVEThe midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported.METHODSThe ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion.RESULTSThree hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications.CONCLUSIONWhile treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

01 Jul 2024·Breast Cancer Research and Treatment

Tolerability and effectiveness of palbociclib in older women with metastatic breast cancer

Article

Author: Mooijaart, Simon P ; Houtsma, Danny ; de Glas, Nienke A ; Spierings, Leontine E A M M ; Oosterkamp, Hendrika M ; van den Bos, Frederiek ; Westerman, Elsbeth M ; Vulink, Annelie J E ; Van der Deure, Wendy M ; Baltussen, Joosje C ; Portielje, Johanneke E A

AbstractPurposePalbociclib has become the standard of care for estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer, but real-world evidence in older women remains scarce. Therefore, we investigated tolerability of palbociclib in older women with metastatic breast cancer.MethodsConsecutive women aged ≥ 70 with ER+/HER2- metastatic breast cancer, treated with palbociclib in any treatment line in six hospitals, were included. Primary endpoint was grade ≥ 3 palbociclib-related toxicity. Predictors of toxicity were identified using logistic regression models. Progression-free survival (PFS) and overall survival (OS) were estimated using Kaplan Meier.ResultsWe included 144 women with a median age of 74 years. Grade 3–4 toxicity occurred in 54% of patients, of which neutropenia (37%) was most common. No neutropenic fever or grade 5 toxicity occurred. Dose reduction during treatment occurred in 50% of patients, 8% discontinued treatment due to toxicity and 3% were hospitalized due to toxicity. Polypharmacy (odds ratio (OR) 2.50; 95% confidence interval (CI) 1.12–5.58) and pretreatment low leukocytes (OR 4.81; 95% CI 1.27–18.21) were associated with grade 3–4 toxicity, while comorbidities were not. In first-line systemic therapy, median PFS was 12 months and median OS 32 months. In second-line, median PFS was 12 months and median OS 31 months.ConclusionAlthough grade 3–4 toxicity and dose reductions occurred frequently, most were expected and managed by dose reductions, showing that palbociclib is generally well tolerated and thus represents a valuable treatment option in the older population.

100 Deals associated with HagaZiekenhuis

100 Translational Medicine associated with HagaZiekenhuis

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