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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…

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…

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?

A phase III Prospective Externally Controlled Non-Inferiority Cohort Trial to Compare the Efficacy of Re-Irradiation Schedules in Glioma (RISinG)

To determine if re-irradiation in 4 fractions is non-inferior to 10 fractions in the primary endpoint of survival after re-irradiation. Secondary objectives are to establish and compare health related quality of life (HRQoL), recurrence patterns,…

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

Zie protocol, hoofdstuk 3 (Objectives)

[18F]fluor-PEG-folate PET/CT imaging in Giant Cell Arteritis.

Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.Secondary objectives are:- Assessment of the relationship between…

Targeting metabolic flexibility in ALS (MetFlex); safety and tolerability of trimetazidine for the treatment of ALS;An investigator initiated and conducted, multicentre, international, open-label Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND)

The objectives of this study are to determine:• The safety and tolerability of trimetazidine in patients with ALS/MND• The change from baseline in oxidative stress markers in patients with ALS/MND after the initiation of trimetazidine• The change…

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…

Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a randomized phase II clinical trial

to compare the short-term toxicity of the conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week Overall Treatment Time (OTT) to 14 x 3 Gy, once daily fractionation in a three-week OTT, with respect to the rate of postoperative…

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.

Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma: A Randomized Phase 2 Study

The primary objective of the study is :To assess MRD negativity rate by NGF after 9 cycles for all eligible ITT patients of KRd versus Rd in patients with high-risk SMMSecondary objectives:• To assess MRD (NGF) negativity rate after 4 cycles of…

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…

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Primary Objectives: Safety Assessments: Effect of Administration of Relacorilant on: • Incidence of TEAEs (assessed monthly): TEAEs, SAEs, treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment• Clinical laboratory tests…

A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN)

The primary objective of the study is to assess the pharmacokinetics (PK) of PXL770 in AMN subjects at the dose of 500mg once daily (OD) and 250mg twice daily (BID) after 4 weeks of treatment.