Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.

开始日期2025-06-01

申办/合作机构

Catharina Ziekenhuis

[+3]

NCT06762652

/ Not yet recruitingN/AIIT

ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial

The objective of the RESCUE-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, ICU (re)admission and surgical interventions after esophagectomy for esophageal cancer.

开始日期2025-06-01

申办/合作机构

Radboud University Medical Center

[+6]

NCT06768060

/ RecruitingN/AIIT

Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women with a Baby in Breech Presentation

The study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. It is hypothesized that this intervention will increase the ECV success rate and decrease the pain experienced after the ECV.

开始日期2025-02-27

申办/合作机构

Catharina Ziekenhuis

[+1]

100 项与 Catharina Ziekenhuis 相关的临床结果

登录后查看更多信息

0 项与 Catharina Ziekenhuis 相关的专利（医药）

登录后查看更多信息

4,076

项与 Catharina Ziekenhuis 相关的文献（医药）

2025-12-01·Cancer Chemotherapy and Pharmacology

Thymine as potential biomarker to predict 5-FU systemic exposure in patients with gastro-intestinal cancer: a prospective pharmacokinetic study (FUUT-trial)

Article

作者: Creemers, Geert-Jan M ; Maring, Jan Gerard ; Moes, Dirk Jan A R ; van den Wildenberg, Sebastian A H ; Bax, Ramon ; Hanrath, Maarten A ; Bet, Pierre M ; Deenen, Maarten J ; Banken, Evi ; van de Kerkhof, Daan ; van den Bosch, Bianca J C ; Boisdron-Celle, Michele ; van Hellemond, Irene E G

AbstractPurposeIn 20–30% of the patients, fluoropyrimidines (5-FU) based chemotherapy leads to severe toxicity, which is associated with dihydropyridine dehydrogenase (DPD) deficiency. Therefore, DPYD genotyping became standard practice before treatment with fluoropyrimidines. Nevertheless, only 17% of the patients with severe toxicity have a DPYD variant. Therefore, an urgent need persists to investigate other strategies contributing to prediction and prevention of toxicity. Endogenous DPD substrates are considered as potential biomarkers to predict toxicity, yet contradictional data exist on demonstrating uracil as a reliable biomarker. Thymine as biomarker for toxicity has been investigated less. The aim of this study was to determine the association between the concentrations of uracil, thymine dihydrouracil (DHU) and dihydrothymine (DHT), with the systemic drug exposure of 5-FU and DPD enzyme activity in patients treated with 5-FU.MethodsWe included 36 patients with gastrointestinal malignancy who received 5-FU infusion. DPYD genotyping was conducted before start of treatment. Blood samples for determining 5-FU, uracil and thymine concentrations during infusion and DPD enzyme activity were taken.ResultsWe found a significant correlation between the 5-FU systematic exposure and baseline thymine concentrations (R2 = 0.1468; p = 0.0402). DPD enzyme activity was significantly correlated with baseline thymine concentrations but no correlation was found between DPD enzyme activity and 5-FU systemic drug exposure.Conclusion5-FU dose individualization based on thymine concentrations could be a promising addition to DPYD genotyping to predict 5-FU-induced toxicity. Larger prospective trials are needed to examine thymine as predictor for toxicity in daily practice.Trial registrationTrial NL7539 at ‘Overview of Medical Research in the Netherlands’ (ID NL-OMON21471). Date of registration 19-02-2019.

2025-09-01·International Journal of Medical Informatics

Validation of the advanced alert monitor in a Dutch hospital using local optimization and refinement of the outcome definition

Article

作者: Turco, Simona ; Bakkes, Tom H G F ; Bouwman, R Arthur ; Mischi, Massimo ; De Bie Dekker, Ashley J R ; van der Stam, Jonna A ; Kaymak, Uzay

BACKGROUNDThe Advanced Alert Monitor (AAM) is a data-driven Early Warning Score (EWS) system designed to predict ICU admission or mortality within 12 hours. It has demonstrated superior performance compared to the National Early Warning Score (NEWS) and contributed to a consortium-wide reduction in mortality, showcasing its potential for clinical use.OBJECTIVEThe study evaluates the generalizability of the AAM in a Dutch hospital setting, comparing its performance against the NEWS and a locally optimized AAM (LO-AAM). Additionally, it investigates how different outcome definitions influence system performance.METHODElectronic medical record (EMR) data from Catharina Hospital in Eindhoven, Netherlands, were used to reproduce the AAM and train the LO-AAM. Both were evaluated against the NEWS using two outcome definitions: the original study definition and an adapted definition that includes mortality regardless of care order status. Feature importance analysis was conducted to assess the impact of these outcome definitions on model performance.RESULTSThe AAM achieved an AUROC of 79.9% against NEWS's 74.2%. However, under the modified outcome definition, the NEWS outperformed the AAM. LO-AAM outperformed both AAM and NEWS in all outcomes. Feature importance analysis showed a greater emphasis on physiological features for the LO-AAM trained on the adapted outcome.CONCLUSIONThe AAM demonstrates generalizability beyond its original population, but local optimization significantly enhances its performance. Outcome definitions critically affect the performance of the NEWS, AAM, and LO-AAM. The adapted outcome includes a wider scope of mortality as an adverse event, leading to an increase in performance for all EWSs.

2025-08-01·Intensive and Critical Care Nursing

Comparative analysis of fully automated vs. conventional ventilation in postoperative cardiac surgery patients: Impact on alarms, interventions, and nurse acceptance

Article

作者: Nabben, Daphne L J ; van Leijsen, Tobias ; De Vries, Tineke J C ; Montenij, Leon ; Buiteman-Kruizinga, Laura A ; Kloeze, Carla ; Dekker, Michiel A C ; De Bie Dekker, Ashley J R ; Korsten, Erik H M ; Bindels, Alexander J G H ; Bouwman, Arthur R ; Schultz, Marcus J ; van Meenen, David M P ; van Haren, Lisan M A A ; Neto, Ary Serpa ; Paulus, Frederique

OBJECTIVESTo compare the number of alarms, interventions and nurses' acceptance of automated ventilation with INTELLiVENT-ASV versus conventional ventilation strategy in patients receiving postoperative ventilation after cardiac surgery.METHODSThis preplanned secondary analysis of the 'POSITiVE' randomized clinical trial compared INTELLiVENT-ASV (automated ventilation) with conventional ventilation in postoperative cardiac surgery patients. The number of critical alarms and manual ventilator interventions were compared during the first three hours of ventilation or until extubation. Nurses' acceptance was assessed using a Technology Acceptance Model 2-based questionnaire and a user acceptance score from 1 to 10.RESULTSPOSITiVE randomized 220 patients (109 to automated and 111 to conventional ventilation). The average number of critical alarms per monitoring hour was similar between the automated and conventional group (5.6 vs 5.7; p = 0.823). The automated group required fewer manual interventions per monitoring hour for both ventilation control (0.7 vs 1.9; p < 0.001) and alarm management (2.0 vs 2.8; p < 0.001). The automated ventilation mode scored higher for perceived usefulness (2.6 vs 2.1; p < 0.001) and user acceptance (8.0 vs 7.0; p < 0.001), but similar for perceived ease of use.CONCLUSIONSAutomated ventilation for postoperative cardiac surgery patients had similar alarm frequencies as conventional ventilation, but reduced the number of interventions and showed higher nurses' acceptance, indicating its potential to optimize patient care and reduce nurses' workload.IMPLICATIONS FOR CLINICAL PRACTICEOur findings suggest that automated ventilation modes like INTELLiVENT-ASV can reduce the frequency of manual interventions and improve nurses' acceptance, which may help alleviate nurses' workload for postoperative cardiac surgery patients.

100 项与 Catharina Ziekenhuis 相关的药物交易

登录后查看更多信息

100 项与 Catharina Ziekenhuis 相关的转化医学

登录后查看更多信息