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Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects With Alzheimer*s Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Primary objective:To evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e., previously treated…

IMPROVE: Improving anxiety treatment by Modulating emotional memories PRiOr to in Vivo Exposure:
A randomized controlled trial.

The first goal of the current research is to investigate whether EMDR prior to CBT, compared to an active psychological control condition (*supportive counseling*), improves treatment tolerability, adherence, and effectiveness. The second goal is to…

rotational ThROmboelastometry in Patients at risk for disseminated Intravascular Coagulation*

The aim of this study is twofold: 1) to measure ROTEM profiles in patients at risk for DIC to determine cut off values of ROTEM corresponding to the currently used International Society for Thrombosis and Haemostasis (ISTH) DIC scores, as well as to…

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer

To evaluate whether Telisotuzumab Vedotin improves response rate and survival in participants who are c-Met+ with NSCLC. For the additional monotherapy cohort :Primary objective is to evaluate the safety and tolerability of telisotuzumab vedotin…

The importance of early brain changes in patients with MS with regard to cognitive and physical outcome

The main objective of this project is to identify the early brain changes in MS (i.e. patients that are recently diagnosed with MS) that can be measured by advanced structural and functional (network) imaging measures. Additionally, we will…

Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy (ENFORCE)

This study has been transitioned to CTIS with ID 2024-511340-29-00 check the CTIS register for the current data. Primary Objective: Evaluate if testosterone replacement therapy (TRT) in (a)symptomatic testosterone deficient men with prostate cancer…

Cardiac output, cerebral perfusion and cognition in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation.

the objectives of the CP-TAVI II study are 1A) to identify whether an increase in cardiac output after TAVI is associated with an increase of global CBF; 1B) explore regional differences in CBF after TAVI; 1C) determine whether (global or regional)…

Study on the potential pharmacokinetic interaction between cannabidiol (CBD) and tamoxifen in patients with primary breast cancer

To determine the potential pharmacokinetic interaction between CBD and endoxifen.Secondary objective: To investigate side effects of CBD and to determine the pharmacokinetic profile of CBD

LIBRETTO-431: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Platinum-Pemetrexed Chemotherapy Plus Investigator*s Choice of Pembrolizumab in Patients with Advanced, Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2023-506783-14-00 check the CTIS register for the current data. The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin…

Determination of the iodine status in pregnant women in the Netherlands.
Are current iodine intake recommendations still adequate?

To determine iodine deficiency in pregnant women in the Netherlands.

The effect of targeted nutrient supplementation on physical activity and health related quality of life in COPD

To investigate the efficacy of targeted nutrient supplementation on daily physical activity level as well as generic health status in patients with moderate to very severe COPD. Additionally, we aim to disentangle the relative effect of targeted…

Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial

This study has been transitioned to CTIS with ID 2023-505877-34-00 check the CTIS register for the current data. To determine the optimal treatment strategy in early dcSSc: the effect of HSCT as upfront therapy compared with that of…

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

This study has been transitioned to CTIS with ID 2023-503291-24-00 check the CTIS register for the current data. Main objective:Dose Escalation Part:• To assess the safety and tolerability of DF1001 monotherapy, and to determine the Maximum…

Altered brain dynamics of self-voice perception in voice hearers

This study will rely on a well-replicated auditory-motor task combined with EEG in two separate experiments (Experiment. 1: speech manipulation and Experiment. 2: emotion and uncertainty manipulations) to elucidate how misattribution of simple (…

Functioning of the HPA-axis in patients with Complex Regional Pain Syndrome

1. To explore the complex relation between CRPS, functioning of the HPA-axis and inflammatory activation of the immune system.2. To assess associations between the HPA-axis and psychosocial determinants. 3. To explore the possible role of…

A Phase 1 Pharmacology Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, in Healthy Volunteers.

PrimaryTo determine the pharmacologically optimal dose of ALRN-6924 to induce transient cell cycle arrest in human bone marrow and other tissues.SecondaryTo characterize relative to ALRN-6924 administration the time to onset, the magnitude, and the…

Prevention of asthma and respiratory symptoms in young children with a nutritional intervention

Objective: Foods consisting of locally grown seasonal vegetables, beef, whole milk and dairy butter with a balanced composition of omega 3 and 6 fatty acids and a wide range of essential micronutrients positively influences the developing immune…

A phase III, randomized, controlled, open-label, multicenter, global study of capmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advanced or metastatic (stage IIIB/IIIC or IV) NSCLC harboring MET exon 14 skipping mutation (MET*ex14)

In this study, we want to find out whether the new drug capmatinib is more effective (i.e. better inhibits the growth of cancer cells) than the widely used chemotherapy docetaxel. In addition, it will be assessed whether treatment with capmatinib is…

The oropharyngeal microbiome and metabolome as potential novel biomarker for disease progression or treatment response in head and neck squamous cell carcinoma (HNSCC); a pilot study.

Primary objectives: • To define any alterations in the oral and gut microbiome and metabolome in patients with HNSCC compared to healthy controls;• To investigate the dynamics oral and gut microbiome and metabolome in HNSCC before, during and after…

A Phase II, randomized, multi-center, placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud*s phenomenon (RP) and peripheral vascular blood flow, in subjects with systemic sclerosis (SSc)

Primary:To determine the safety and efficacy of GS-248 versus placebo on RP in subjects with SSc.Secondary:To determine the efficacy of GS-248 on peripheral vascular blood flow in subjects with SSc and RP.Exploratory:• To explore the…