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A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of
Emactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour.

Primary:To estimate the treatment effect of emactuzumab on objective response rate (ORR) by 6 months from initiation of therapy in the blinded phase compared to placeboSecondary:the effect of emactuzumab on clinical outcome assessments (COAs) for:o…

Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin

This study has been transitioned to CTIS with ID 2023-507582-25-00 check the CTIS register for the current data. PRIMARY OBJECTIVESThe primary objective of MAKEI V is to assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/…

A phase 1, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose and food effect study to evaluate the safety, tolerability, and pharmacokinetics of LMT503 in healthy subjects.

This study has been transitioned to CTIS with ID 2024-519180-17-00 check the CTIS register for the current data. In this study we will investigate how safe the new compound LMT503 is and how well it is tolerated when it is used by healthy…

PRone positioN in patients with
spontanEous ventiLation and
acute hypoxemic respIratory
FailurE- The PRONELIFE
Randomized Controlled Trial

PRONELIFE is the first randomized controlled trial comparing the prone position with the supine position in patients with acute hypoxemic respiratory failure from any cause that recruits a sufficient number of patients to test the hypothesis that…

Reduction of blood loss in pediatric osteotomies around the hip
- A randomized placebo-controlled trial with tranexamic acid -

This study has been transitioned to CTIS with ID 2024-516324-34-01 check the CTIS register for the current data. To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a…

Effectiveness and working mechanisms of e-health modules focusing on worry and self-esteem for anxiety symptoms in undergraduates

Primary objective: To map the effectiveness and working mechanisms of e-health modules on worrying and self-esteem in reducing subclinical anxiety symptoms among students

Non-inferiority in operation time when using 3D SPECT/CT imaging, compared to standard 2D imaging, during sentinel node procedure for breast cancer patients

PRIMARY QUESTIONDuring the sentinel node procedure in breast cancer patients, does a 3D SPECT/CT protocol not lead to a longer operation time to remove axillary sentinel nodes, compared to the 2D standard protocol?• H0: OK-time(SPECT/CT) - OK-time(…

Implementing Robot-assisted knee arthroplasty at a high-volume, peripheral hospital

Primary Objective: to investigate whether image-based ROSA procedures, which require more preparation time from the surgeon, reduce operation duration and required materials in the operation ward, as compared to imageless procedures, for which ROSA…

Minimally-invasive upper extremity versus lower extremity for accessory access sites during transcatheter aortic valve implantation

To assess the safety and efficacy of a *minimally-invasive upper extremity* approach (radial artery for pigtail catheter and brachial vein for temporary pacemaker when not pacing over the left ventricular stiff wire OR radial artery and pacing over…

Topical haemostatic agent Arista* AH compared to nasal packing following turbinate surgery: a prospective randomised controlled trial.

The main objective of this randomised controlled study is to investigate whether patients treated with Arista* AH have less postoperative complaints after inferior turbinate surgery compared to patients treated with non-absorbable Merocel® nasal…

A Randomized, Double-blind, Placebo-controlled Single Ascending Dose and Open-label Multi-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-APP in Adult Patients with Early-onset Alzheimer*s Disease (EOAD)

This study has been transitioned to CTIS with ID 2023-508363-79-00 check the CTIS register for the current data. Part AMain objectives: • To evaluate the safety and tolerability of single intrathecal (IT) doses of ALN-APP in adult patients with…

Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

Primary-Assess the efficacy of apitegromab compared with placebo using the HFMSE in patients 2 through 12 years oldKey secondary-Assess the efficacy of apitegromab compared with placebo based on the number of patients with clinical improvement in…

an open label, randomised, phase 2 study to evaluate the safety and efficacy of mtl-cebpa administered in combination with sorafenib or sorafenib alone, in TKI naïve participants with previously treated advanced hepatocellular carcinoma (HCC) and hepatitis B or hepatitis C virus (outreach2)

We compare the efficacy and safety of the new medication MTL-CEBPA in combination with sorafenib with the efficacy and safety of sorafenib alone. Sorafenib is already being used for the treatment of HCC.

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension
Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants with Active Systemic Lupus Erythematosus.

This study has been transitioned to CTIS with ID 2023-505635-13-00 check the CTIS register for the current data. The Primary Objective of this Clinical Trial is to evaluate the long-term safety and tolerability of litifilimab in participants with…

MR-guided LITT therapy in patients with primary irresectable glioblastoma: a multicenter randomized controlled trial

To prospectively evaluate the (cost)-effectiveness of LITT plus chemoradiation therapy (CRT) vs. CRT alone in patients with primary irresectable glioblastoma (GBM).

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate
the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With
Moderately to Severely Active Crohn's Disease

Primary objective:- To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC inductionSecondary objectives:- To evaluate the efficacy of guselkumab SC across a range of outcome measures- To evaluate the safety…

Effect of protein supplementation on fat free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial.

The main aim of this study is to assess whether protein supplementation could prevent excessive fat free mass loss during the first year after bariatric surgery.

Triple therapy convenience by the use of one or multiple inhaler and digital support in Chronic Obstructive Pulmonary Disease

The primary objective of this study is to investigate if single-inhaler triple therapy (SITT, in this study Trimbow®) is superior to multi-inhaler triple therapy (MITT, in this study Bevespi® and Qvar®) in terms of adherence to inhaled…

LOFIT: Lifestyle front Office For Integrating lifestyle medicine in the Treatment of patients: a novel care-model towards community-based options for lifestyle change

The main aim of the LOFIT study is to determine the (cost) effectiveness of a hospital-based dedicated LFO in comparison with usual care 12 months after participation

A phase 3 study of PTC923 in subjects with phenylketonuria

Primary:• To evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria (PKU) as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (ie, the average of each respective…