Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.
This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response.

开始日期2024-05-01

申办/合作机构

Haaglanden Medisch Centrum

[+2]

NCT06082492 / RecruitingN/AIIT

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.

开始日期2024-03-19

申办/合作机构

Radboud University Medical Center

[+17]

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0 项与 Haaglanden Medisch Centrum 相关的专利（医药）

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2021-11-08·Journal of Crohn's and Colitis1区 · 医学

Ustekinuma b for Crohn’s Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study

1区 · 医学

Article

作者: West, Rachel L ; Biemans, Vince B C ; Jansen, Jeroen M ; Pierik, Marieke ; Dijkstra, Gerard ; de Boer, Nanne K H ; van der Woude, C Janneke ; Straatmijer, Tessa ; de Vries, Annemarie C ; Haans, Jeoffrey J L ; Oldenburg, Bas ; van der Marel, Sander ; Hoentjen, Frank ; van Dop, Willemijn A ; Duijvestein, Marjolijn ; Visschedijk, Marijn C ; van der Meulen-de Jong, Andrea E ; Maljaars, P W Jeroen ; Bodelier, Alexander G L ; Ponsioen, Cyriel Y

AbstractAimsUstekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin [IL]-12 and IL-23. It is registered for the treatment of inflammatory bowel diseases. We assessed the 2-year effectiveness and safety of ustekinumab in a real world, prospective cohort of patients with Crohn’s disease [CD].MethodsPatients who started ustekinumab were prospectively enrolled in the nationwide Initiative on Crohn and Colitis [ICC] Registry. At weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index≤ 4 points], biochemical remission (faecal calprotectin ≤ 200 μg/g and/or C-reactive protein ≤5 mg/L], perianal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104.ResultsIn total, 252 CD patients with at least 2 years of follow-up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission was 32.3% [81/251], 41.4% [104/251], 39% [97/249] and 34.0% [84/247] at weeks 12, 24, 52 and 104, respectively. In patients with combined clinical and biochemical disease activity at baseline [n = 122], the corticosteroid-free clinical remission rates were 23.8% [29/122], 35.2% [43/122], 40.0% [48/120] and 32.8% [39/119] at weeks 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks in all patients was 64.3% and 54.8%, respectively. The main reason for discontinuing treatment after 52 weeks was loss of response [66.7%]. No new safety issues were observed.ConclusionAfter 104 weeks of ustekinumab treatment, one-third of CD patients were in corticosteroid-free clinical remission.

2021-05-27·Journal of Crohn's and Colitis

P286 Ustekinumab for Crohn’s Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study

作者: Ponsioen, C Y ; Straatmijer, T ; Visschedijk, M C ; Hoentjen, F ; Biemans, V B C ; West, R ; Oldenburg, B ; Bodelier, A G ; Haans, J J L ; Jansen, J M ; de Vries, A C ; van der Meulen- de Jong, A E ; van der Marel, S ; van Dop, W ; van der Woude, C J ; Dijkstra, G ; Duijvestein, M ; Pierik, M ; Maljaars, P W J ; de Boer, N K H

AbstractBackgroundUstekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin (IL)-12 and IL-23. It is registered for the treatment of Crohn’s disease (CD) and ulcerative colitis. We assessed the two-year efficacy and safety of ustekinumab in a real world, prospective cohort of CD patients.MethodsCD patients who started ustekinumab in regular care were prospectively enrolled in the nationwide Initiative on Crohn and Colitis Registry. At week 0, 12, 24, 52 and 104, clinical remission (HBI ≤ 4 points), biochemical remission (fecal calprotectin (FC) ≤200 μg/g and/or CRP ≤5 mg/L), peri-anal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. Patients starting therapy less than two years ago were excluded for the current evaluation. The primary outcome was corticosteroid-free clinical remission at week 104.ResultsIn total, 252 CD patient with at least two years of follow up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission at week 12, 24, 52 and 104 was 32.3% (81/251), 41.4% (104/251), 39% (97/249) and 34.0% (84/247), respectively. Of the 97 patients in corticosteroid free clinical remission at week 52, 58 (59.8%) were still in corticosteroid-free clinical remission at week 104. In patients with combined clinical and biochemical disease activity at baseline (n=122), the corticosteroid-free clinical remission rates were 23.8% (29/122), 35.2% (43/122), 40.0% (48/120) and 32.8% (39/119) at week 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks was 64.3% and 54.8%, respectively. There were no predictive factors associated with corticosteroid-free clinical remission at week 104 on univariate and multivariate analysis. Most common adverse events were headache, skin reaction and musculoskeletal complaints. Two patients stopped ustekinumab due to an infection after 8 and 30 weeks of treatment (mild fever syndrome and moderate upper airway infection, respectively). The main reason for discontinuing treatment after 52 weeks was loss of response (66.7%).ConclusionUstekinumab was effective and relatively safe in our real world, prospective cohort of CD patients. After 104 weeks of ustekinumab treatment, one third of patients were in corticosteroid-free clinical remission.

2016-07-01·De Verpleegkundig Specialist

Het gevaar van spoedeisende zorg buiten de reguliere behandelkamers

作者: M.C. van der Linden ; R.W. Derlet ; J.R. Richards

100 项与 Haaglanden Medisch Centrum 相关的药物交易

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100 项与 Haaglanden Medisch Centrum 相关的转化医学

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