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Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)

This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS),…

Assessing and predicting functional and quality of life-related outcomes of islet and pancreatic transplantation in patients with type 1 diabetes mellitus

There are two objectives for this study: first, to find specific serum beta cell damage markers that can serve as a clinical predictive tool for beta cell allograft loss. Second, to compare quality of life and diabetes-related outcomes in patients…

Evaluation of 18F-FDHT PET/CT as a predictor of response in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide.

Primary objective: to explore 18F-FDHT PET/CT as a predictor of response in patients with metastasized CRPC to be treated with enzalutamide. Secondary objective: to explore 18F-FDHT PET/CT as a predictor of clinical survival endpoints in patients…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION

EFFICACY OBJECTIVESThe primary efficacy objective of this study is to evaluate the efficacy of intravitreal injections of 10 mg lampalizumab administered Q4W or Q6W in CFI profile biomarker positive and CFI profile biomarker-negative patients…

The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION

EFFICACY OBJECTIVESThe primary efficacy objective of this study is to evaluate the efficacy of intravitreal injections of 10 mg lampalizumab administered Q4W or Q6W in CFI profile biomarker positive and CFI profile biomarker-negative patients…

AdreView* Myocardial Imaging for Risk Evaluation * A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 25% * LVEF * 35%. ADMIRE-ICD

To demonstrate the efficacy of AdreView* imaging for appropriately guiding the decision of ICD implantation in a population of New York Heart Association (NYHA) class II and III Heart Failure (HF) patients with 25% * left ventricular ejection…

Uniform FDG-PET guided gradient dose prescription to reduce late radiation toxicity (UPGRADE RT): a randomised controlled trial with dose reduction to the elective neck in head and neck squamous cell carcinoma

The UPGRADE-RT trial will investigate whether de-escalation of the elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life…

Non-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset.

The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect anacceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. Then the MRL could…

Varenicline, a partial nicotinic receptor agonist, for the treatment of excessive daytime sleepiness in Parkinson*s disease: a placebo-controlled cross-over study

This study is aimed to determine the efficacy of varenicline in reducing EDS in PD patients.

A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients.

The objective of this trial is to investigate whether Eltrombopag added to standard immunosuppressive treatment increases the rate of early (at three months) complete response and blood counts and can be use as front-line therapy for SAA treatment.

The use of Indocyanine green fluorescence with near-infrared imaging to intra-operatively assess tissue perfusion in gastrointestinal surgery.

To investigate the feasibility and utility of indocyanine green fluorescence imaging for intraoperative perfusion assessment in patients undergoing gastro-intestinal surgery, primarily measured by the number of intraoperative changes in operation…

SSPE * The Management of Subsegmental Pulmonary Embolism: A Prospective Cohort Study

See chapter 'objectives' of study protocol (page 12)

Generating normal values for antibody response in "healthy" patients of age

To generate a set of normal values in people over 60 that can be expected to have an normal immune system, in order to be able to interpret the immune system of eldery patients with repeated airway infections.

Comparison of adenoma miss rate and adenoma detection rates between Endocuff Vission-assisted colonoscopy and conventional colonoscopy: a multicenter randomized trial (EXCEED study)

(1) To compare adenoma miss rates (AMR) between Endocuff Vision-assisted colonoscopy (EAC) and conventionalcolonoscopy (CC)(2) To compare adenoma detection rates (ADR) between EAC and CC(3) To assess whether a proposed increased ADR and reduced AMR…

EMG registration of the pelvic floor and pelvic floor muscle activity patterns during, abdominal, hip adductor, and gluteal muscle contractions in healthy women

To describe the EMG activity of the pelvic floor muscles (PFM) with a bi-polar EMG probe and the MAPLe and effect on the registered EMG activity with the probes in relation to the contractions of the muscles surrounding the pelvic floor. To describe…

Performance of the Medtronic Guardian Connect vs the Free Style Libre Flash Monitor in extreme sports conditions in subjects with diabetes

Primary objective To assess accuracy of GCCGM vs FLFM in 18 subjects with diabetes during a 6 day mountainbike tour in the AlpsSecondary objectives To assess the (differences in ) time in hypo-, normo- ,and hyperglycemia (expressed in minutes per…

Validation of digital-PCR analysis through programmed imatinib interruption in PCR negative chronic myeloid leukemia patients.

Primary ObjectiveTo assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.Secondary Objectives• To estimate…

Effects of vernakalant and flecainide on atrial contractility in patients with atrial fibrillation

Primary Objective: to compare the atrial contractility by means of echocardiography between patients receiving flecainide and vernakalant i.v. after conversion to sinus rhythmSecondary Objective(s): 2a. To compare the conversion rate of AF between…

Effectiveness of ultrasound imaging in general practice: optimising the management of patients with non-chronic shoulder complaints.

To optimize the management of non-chronic shoulder pain in primary care by the introduction of ultrasound as a diagnostic triage tool. The following research questions will be addressed:1. What are the effects of diagnostic ultrasound and its…