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The use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams

Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. Also other secondary endpoints will be evaluated.

Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands

Primary Objective: To determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxisSecondary Objectives:• To determine the dose-dependent protective efficacy of NF135.C10 CPS-immunization against homologous…

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…

Effects of dosing time on the pharmacokinetics and pharmacodynamics of sunitinib.

Primairy objective:To investigate whether the pharmacokinetics of sunitinib are influenced by circadian rhythm.Secondary objective:- to investigate whether daily variation in CYP3A4 activity exists in humans, based on midazolam and 4beta-…

Clinical and radiological evaluation of Signature* unicompartmental knee arthroplasty
A Prospective, Multi-centre, Randomized, Double blind study

Primary- To evaluate the initial and long-term clinical results in terms of function, quality of life and pain/satisfaction of the Signature* procedure compared to the standard operation instruments.- To evaluate the alignment of the Signature*…

Tinnitus suppression with electrical stimulation using cochlear implants (CI).

The main objective of the present study is to investigate the optimal stimulation pattern for tinnitus suppression in a structured way. Our study will focus on two parameters: stimulus level and anatomical stimulation site inside the cochlea.

Effect of the SGLT-2 inhibitor dapagliflozine on impaired awareness of hypoglycemia in type 1 diabetes

Primary objective: to investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the awareness of and counterregulatory hormone responses to hypoglycemia in people with type 1 diabetes and impaired awareness of hypoglycemia.…

*CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept*

This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.

Travel-Imported Arbovirus infections and mHealth applications for outbreak Risk Assessment: ZIeKA monitor part 2

Our primary objective is to enable rapid estimation of the current and future risks of importation into the Netherlands of majorarboviral Aedes-borne diseases (Dengue, Chikunguya, Zika and Yellow Fever viruses). The possibility of (re)establishment…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects with Multiple Osteochondromas

Primary Objective• To evaluate the efficacy of two dosage regimens of palovarotene compared with placebo in preventing new osteochondromas (OCs) in subjects with multiple osteochondromas (MO) due to exostosin 1 (Ext1) or exostosin 2 (Ext2) mutations…

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…

Registry of Endpoints and Validated Experiences in ALS

To determine the relationships between respiratory function, secretion management, RTIs and mortality in order to optimize medical decision-making.

An International Multicentre, Open-Label First in Human Phase I/II study to evaluate the safety, tolerability, biodistribution and antitumour activity of 177Lu-3BP-227 for the treatment of subjects with solid tumours expressing neurotensin receptor 1

Primary objectivesPhase ITo establish the safety and tolerability of fractionated intravenous (i.v.) administrations of 177Lu-3BP-227 in subjects with unresectable, locally advanced or metastatic cancers expressing NTSR1.Phase IITo estimate ORR of…

A Randomized, Controlled, Double-blind Continuation Study Comparing the Long*term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis

Primary Objective* To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. Secondary Objectives* To assess the…

A single-arm, open-label, multicenter study of enfortumab vedotin (ASG-22CE) for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor (CPI) therapy.

Primary:* * To determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed objective response rate (ORR) in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn*s Disease (CARMEN CD 305)

Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…

Promoting implementation of seizure detection devices in epilepsy care: the PROMISE study

1. To test the performance of the wearable SDD (Nightwatch) prospectively and the remote SDDs (video and audio) retrospectively in a family home setting. 2. To explore the feasibility of the Nightwatch

A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…

A randomized, single-blinded, 3-way cross-over trial to investigate the pharmacokinetics of sustained release cysteamine bitartrate (PO-001) in healthy adult volunteers.

- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…

Open label multicentre randomized trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everolimus in the novo renal transplantation in elderly patients.

This study has been transitioned to CTIS with ID 2024-516509-22-00 check the CTIS register for the current data. 1. To test the hypothesis that an age adapted immunosuppressive regimen targeted at reduced immunosuppression with low calcineurin…