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BIOFLOW-V: BIOTRONIK * A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions * V

To assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent…

Music Under Surgery In Children

The main objective of this study is to investigate whether a music intervention as complementary treatment is effective in reducing anxiety and distress around surgery. Secondary objectives are effects of music on pain, on preoperative anxiety, on…

Pain in Dementia- Prevalence and Diagnostics

Objectives: 1. To assess the prevalence of pain in elderly with dementia and to study the relationship between the various subtypes of dementia and the presence of specific types of pain(e.g. nociceptive pain, neuropathic pain, and orofacial pain).…

Characterizing Vulnerable Plaques in Non-ST-Elevation Myocardial Infarction using PET-CMR: A Feasibility Study

In patients with NSTEMI we aim to: 1) compare coronary vulnerable plaque detection between 18F-NaF-PET-CMR and invasive coronary angiography, 2) investigate the relation of coronary vulnerable plaques using 18F-NaF-PET with myocardial infarction…

Imaging and Modeling to investigate the mutual relationship of Plaque growth and biomechanical parameters in human coronary arteries

To investigate the association between shear stress and plaque growth and plaque composition changes over time. Furthermore, it will be investigated how these plaque changes influence the local wall stress.

[LONGPDE10] Follow-up measurement of brain phosphodiesterase 10 A (PDE10A) enzyme levels in Huntington*s disease gene expansion carriers, 18 to 28 months after initial PET measurement in CHDIKI1201/PET-HD-PDE10A

The primary objective is to measure the longitudinal changes of PDE10A enzyme availability in the caudate, putamen, and globus pallidus of Huntington*s Disease Gene Expansion Carrier (HDGECs) by comparison of the follow-up and initial Positron…

Anticoagulants for Living Fetuses in women with recurrent miscarriage and inherited thrombophilia; ALIFE2 study

To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia and recurrent miscarriage on live birth.

An observational study to evaluate driving competence in Huntington's disease

Primary objectives:- To investigate possible differences in driving performances between premanifest gene carriers, manifest HD, and control subjects.- To explore if different aspects of cognitive functioning might be a predictor of fitness to drive…

The amount of light to achieve optimal alertness as a function of time of day

This study aims to measure the action spectra of alertness at different time points of the day. The question to be answered is how time-of-day modulates the amount of light that is needed for optimal alertness. This project will result in a dose-…

Standard laparoscopic low anterior resection versus transanal TME for rectal carcinoma. Comparing the extend and completeness of mesorectal excision evaluated by magnetic resonance imaging*

This study, comparing two cohorts, is designed to determine the postoperative residual mesorectum on MRI after TME. Patients with a clinical T1-3 rectal carcinoma (10cm or less from the anal verge based on preoperative MRI of the pelvis) who…

A phase 1 Study to Evaluate the Safety and Feasibility of Intraoperative Detection of Clear Cell Renal Cell Carcinoma Using Indium-111-DOTA-girentuximab-IRDye800CW

To assess the feasibility and safety of intraoperative dual-modality imaging in patients with renal cell carcinoma with Indium-111-DOTA-girentuximab-IRDye800CW. Secondary objectives are to assess how intraoperative fluorescence imaging results…

Tidal ventilation distribution and patient-ventilator synchrony during Proportional Assist Ventilation with load-adjustable gain factors

To compare the tidal volume distribution and other ventilator parameters between PAV+ and NAVA.

A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN*S DISEASE

The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…

TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral
Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic
Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer
(NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase
Inhibitor (TKI) and Platinum-doublet Chemotherapy

Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…

Optimizing accelerometer data analysis to assess physical activity and sedentary behavior among breast cancer survivors: a laboratory study

1. To validate accelerometer cut-points to asses physical activity and sedentary behavior of breast cancer survivors. 2. To investigate the validity of accelerometers, inclinometers, heart rate and oxygen consumption to assess time spent in…

Dietary treatment of children with Angelman Syndrome and refractory epilepsy

Primary objective: - 50% seizure reduction or more at 3 months of dietary treatment .Secondary objectives: -level of ketosis on KD and MAD.-number of patients maintaining >50% seizure reduction on MAD.-number of withdrawals (not able to…

Ga-68-DOTA-RGD2 PET/CT in patients with head and neck cancer: a potential tracer to image angiogenesis in tumors.

The primary objective of the study is to ascertain the feasibility and safety to image tumor angiogenesis in head- and neck cancer patients using Ga-68-DOTA-RGD2 PET/CT. Secondary objectives are to determine the pharmacokinetics and biodistribution…

A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) (CLDK378A2112)

Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…

Dorsal root ganglion stimulation and motor responses in patients, who have been implanted with a dorsal root ganglion stimulation device: a pilot study

The aim of this pilot study is to investigate if DRG stimulation can evoke motor reactions in the lower extremities in patients who have already been implanted with a DRG stimulator to treat neuropathic pain.

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year