Search for a trial

ARTEMIS: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF).

The primary objective of this study is to determine if ambrisentan is effective in delaying disease progression and death in subjects with IPF.Secondary objectives include evaluation of the safety and effect of ambrisentan on development of…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer

To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)

Multi-center, single-arm study to assess the safety, efficacy, discontinuation rate and pharmacokinetics of the low-dose levonorgestrel intrauterine contraceptive system (LCS12) in post-menarcheal female adolescents under 18 years of age for 1 year, and an optional 2-year extension phase

The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. The incidence of adverse events over 12 month treatment period will be the main…

The value of Platelet-Rich Plasma injections in the treatment of the jumper's knee: a double-blind randomised trial

There is a double study objective:- First the effects of a PRP-injection in the treatment of the jumper's knee in comparison with the effects of a placebo injection - Second the effects of a PRP-injection in comparison with the effects of an…

Cardica C - Port xA * Anastomotic System

The purpose of this study is to demonstrate equivalency of the Cardica * C - Port Xa anastomosis compared to hand sutured anastomoses in patients undergoing CABG with respect to 12 months patency at distal anastomosis site.

Insertion of a central venous catheter through a tegaderm as a preventive measure against catheter colonization and infection

Primary: Investigate if sterile transparent dressing pasted on the skin before CVC insertion reduces the contamination risk of the CVC.Secondary: Investigate if direct contamination has a clinical significance.Investigate what the mayor…

COrrelating plasma Nintedanib COncentRations with efficacy and toxicity in patients with interstitial lung DIseAse

To further research nintedanib PK and correlate them with clinical parameters and toxicity. Results could be used to optimize treatment of nintedanib in the future by dose individualization based on patient*s characteristics or therapeutic drug…

Embryo selection using time-lapse monitoring in IVF and ICSI patients

Does embryo selection using time-lapse monitoring (TLM) with Eeva (Early Embryo Viability Assessment) improve the (cumulative) ongoing pregnancy rate after IVF & ICSI treatments?

Magnetic Resonance Direct Thrombus Imaging for diagnostic management of suspected pelvic vein thrombosis during pregnancy -

Zie protocol, hoofdstuk 3 (Objectives)

Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene

Primary:To assess the effect of bilateral treatment with AAV5-hRKp.RPGR on functional vision as measured by vision-guided mobility assessment.Secondary:To assess changes after treatment administration in retinal function, functional vision, visual…

Piezo-electric versus optical versus open wire pressure guidewires for FFR measurements: comparison of two commercially available pressure wires

- To compare the pressure signals measured by the different available pressure guidewires, specifically the FFR value- To assess the occurrence of hydrostatic errors when using sensor-tipped wires- To assess the occurrence of drift between the…

Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients with Fabry Disease

To evaluate the ongoing safety, tolerability, and efficacy parameters of pegunigalsidase alfa in adult Fabry patients who have successfully completed studies PB-102-F20 and PB-102-F30, or completed at least 48 months in study PB-102-F03.

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens

Primary Objective:• To assess and compare efficacy of sacituzumab govitecan to TPC as measured by progression free survival (PFS) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1…

The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy

Primary objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to insulin (INS) treatment.Secondary objectives:…

Dose tapering and early discontinuation to increase cost-effectiveness of immunotherapy trial number 1

To investigate the non-inferiority of a reduced dose and to develop biomarkers for early treatment response.

Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis: a randomized controlled trial

With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity (clinically and radiologically) compared to the standard (fixed 24 week interval) treatment.

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (MelMarT-II)

This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition, Table 1). The study…

Prospective non-randomised post-market study collecting clinical data on safety and effectiveness of the remed*®-System

This study aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.

Clinical Performance Study Protocol for Use of VENTANA PD-L1 (SP263) CDx Assay in AstraZeneca Study D798AC00001(eVOLVE-Lung02):
A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC) (eVOLVE-Lung02)

The primary objective of the clinical performance study is to demonstrate the clinical performance of VENTANA PD-L1 (SP263) CDx Assay in terms of its ability to identify NSCLC patients who may benefit from treatment with volrustomig plus…

An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Primary:The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH.Secondary:The secondary objective is to follow…