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NCT ID: NCT02113202 Completed - Clinical trials for Adenomatous Polyposis Coli

Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW

FLUOFAP
Start date: March 2014
Phase: Phase 1
Study type: Interventional

There is a need for better visualization of polyps during surveillance endoscopy in patients with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the determination of the optimal tracer dose.

NCT ID: NCT02112994 Completed - Clinical trials for Lysosomal Acid Lipase Deficiency

Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency

Start date: June 24, 2014
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).

NCT ID: NCT02112981 Active, not recruiting - Clinical trials for Coronary Artery Disease

BioMime Vs. Xience Randomised Control Clinical Study

meriT-V
Start date: November 5, 2014
Phase: N/A
Study type: Interventional

meriT-V is a Prospective,active control open lable clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random assignment for treatment of coronary artery disease at multiple multinational centres.

NCT ID: NCT02112877 Completed - Clinical trials for Chronic Venous Disorder

VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction

VIRTUS
Start date: June 26, 2014
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.

NCT ID: NCT02112682 Terminated - Breast Neoplasms Clinical Trials

Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy

Start date: June 2014
Phase: N/A
Study type: Interventional

STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate. HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.

NCT ID: NCT02112474 Completed - Neuropathic Pain Clinical Trials

The Pain Suppressive Effect of Alternative Spinal Cord Stimulation Frequencies

HALO
Start date: November 13, 2014
Phase: N/A
Study type: Interventional

Electrical stimulation of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief has been used for decades. It is used most commonly in patients with chronic neuropathic leg pain, after spinal surgery. Conventional neurostimulation is applied in frequencies of 30 to 60 Hertz (Hz) and perceptible paraesthesias are felt. Stimulation using higher frequencies with sub perception paraesthesias has recently challenged the conventional form of neurostimulation.The high frequency stimulation appears to show better pain relief for both back and limb pain in comparison to low frequency SCS, and may also to be effective in some subjects who did not respond to low frequency SCS.

NCT ID: NCT02112292 Completed - Sensory Science Clinical Trials

The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking

Sweed
Start date: April 2014
Phase: N/A
Study type: Interventional

The endocannabinoid (eCB) system, a neurochemical signalling system consisting of CB-receptors and their endogenous ligands, has been found to be involved in food intake of sweet and palatable foods. Activation of the eCB system increases food intake and vice versa. The mechanism behind this effect is still unknown and the current study aims at clarifying why sweet food intake increases. It is hypothesized that sweet taste intensity increases and that sweet taste is experienced as more pleasant.

NCT ID: NCT02112019 Active, not recruiting - Sjögren's Syndrome Clinical Trials

Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Start date: June 2014
Phase: N/A
Study type: Interventional

Sjögren's syndrome (SS) is an autoimmune inflammatory disorder of the exocrine glands. It particularly affects the lacrimal and salivary glands. Severe dry mouth and eyes are frequently reported as presenting symptoms. These symptoms are in many cases accompanied by nonspecific symptoms, such as malaise and fatigue. In addition, extraglandular manifestations, like purpura, polyneuropathy, and arthritis, can be present. SS affects mainly women with a female/male ratio of 9:1 and can occur at all ages. Due to the irreversible damage to the saliva producing cells, the quantity and quality of saliva reduces. The progressive nature of the syndrome results in a further reduction of salivary flow. Due to hyposalivation the patients suffer from progressive dental decay, dental erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste), inflammation of the oral mucosa and lack of retention of removable dentures. Overall, this can be qualified as a reduction in the quality of life. Until now no effective (palliative) therapy to relieve dry mouth complaints is available. A recent case series study suggests that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients suffering from SS. In this technique the ducts of the salivary glands are rinsed with saline and cortisone and possible strictures are dilated. It is hypothesised that performing a sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and improve the reported mouthfeel score.

NCT ID: NCT02111889 Completed - Clinical trials for Disseminated Malignant Neoplasm

Tumor Kinase Inhibitor Concentrations Measured by PET

PIKTURE
Start date: September 2013
Phase: N/A
Study type: Interventional

The investigators hypothesize that response to kinase inhibitors is dependent on achieving pharmacological active drug levels in tumor tissue and that quantitative PET imaging can predict kinase inhibitors tumor concentrations. The ultimate aim is to develop a quantitative PET based imaging tool to differentiate between patients who will respond to therapy with kinase inhibitors. The main objective of this study is to determine whether tumor concentrations of kinase inhibitors at pharmacological active doses can be predicted from PET studies using tracer amounts (microdosing) of corresponding radiolabeled kinase inhibitors. This objective includes the development and validation of pharmacokinetic models for radiolabeled kinase inhibitors as well as validation of the microdosing concept for kinase inhibitors.

NCT ID: NCT02111577 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

VIABLE
Start date: May 26, 2014
Phase: Phase 3
Study type: Interventional

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.