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NCT ID: NCT02033330 Completed - Clinical trials for Improving Bioavailability

Assessment of Bioavailability of Phenolics From an Orange Peel Extract

Start date: July 2013
Phase: N/A
Study type: Interventional

In this study, the bioavailability of a specific orange peel extract is tested. The composition and morphology of the test product is altered compared to the generic product, which is used as a control. Due to intellectual property issues, more information cannot be given at this moment. Also the difference in bioavailability between a capsule and a lozenge is tested. The hypothesis is that the bioavailability of the altered extract will be improved compared to the control.

NCT ID: NCT02033291 Completed - Cerebral Hemorrhage Clinical Trials

Blood-brain Barrier Quantification in Cerebral Small Vessel Disease

Start date: February 2014
Phase: N/A
Study type: Observational

Cerebral small vessel disease (cSVD) encompasses all pathological processes that affect the small vessels of the brain. On brain-MRI cSVD is characterized by structural brain abnormalities such as white matter lesions (WMLs). Clinically, cSVD is related to acute syndromes as lacunar stroke but also to more chronic health problems such as cognitive decline. Recent literature suggests that a disrupted blood brain barrier (BBB), leading to elevated BBB permeability, may play a pivotal role in the aetiology of cSVD and lacunar stroke. The BBB is a complex system of neuronal, glial and vascular cells which main function is to shield the brain from toxic components and regulate the homeostasis. Elucidating the role of the BBB may have far reaching consequences for the treatment of cSVD patients and the reduction of recurrence rate of the disease. This could lead to a better quality of life among cSVD patients and reduce the economic burden on society. Currently the exact contribution and extent of a possibly defective BBB in cSVD remains largely unclear, due to the lack of a reliable method to accurately quantify the BBB permeability in cSVD patients. As a result, the current treatment consists of treating the cardiovascular risk factors, often with poor results. Quantification of the BBB permeability provides an objective measure of the integrity of the BBB and as such aids the study of the role of the BBB. The aim of this study is to realize a clinically applicable MRI-method to quantify the BBB permeability. Moreover, the method can be used to study the involvement of BBB disruption in other neuropathologies including Alzheimer's disease, vascular dementia, hypertension and diabetes. Primary Study Objective: To realize a clinically applicable quantification of BBB permeability using DCE-MRI by determining the reproducibility of the DCE-MRI method Secondary Study Objective: To achieve the shortest scan duration without compromising the reliability of the BBB permeability quantification. Hypotheses: 1. Using an optimized DCE-MRI method to quantify the BBB permeability, the BBB permeability can be reliably determined in cSVD patients. 2. The scan duration can be shortened without compromising the reliability of the BBB permeability quantification.

NCT ID: NCT02032823 Active, not recruiting - Breast Cancer Clinical Trials

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

OlympiA
Start date: April 22, 2014
Phase: Phase 3
Study type: Interventional

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

NCT ID: NCT02032654 Terminated - Cellulitis Clinical Trials

Duration of ANtibiotic Therapy for CEllulitis

DANCE
Start date: August 26, 2014
Phase: Phase 4
Study type: Interventional

Cellulitis is among the most common infections leading to hospitalization, yet the optimal duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of antibiotics, which is the current standard of care. Recently it has been shown that antibiotic treatment for pneumonia and urinary tract infections can safely and significantly be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.

NCT ID: NCT02032524 Completed - Clinical trials for Glycogen Storage Disease Type II Pompe Disease

Avalglucosidase Alfa Extension Study

NEO-EXT
Start date: February 27, 2014
Phase: Phase 2
Study type: Interventional

Primary Objective: Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa Secondary Objective: Long-term effect of avalglucosidase alfa on pharmacodynamic variables

NCT ID: NCT02032277 Completed - Clinical trials for Triple Negative Breast Cancer

A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

Start date: April 2, 2014
Phase: Phase 3
Study type: Interventional

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

NCT ID: NCT02031809 Completed - Lung Neoplasms Clinical Trials

Multicentric Study VATS Major Introperative Complications

Start date: January 2014
Phase:
Study type: Observational

This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

NCT ID: NCT02031614 Not yet recruiting - Anemia Clinical Trials

The Immunomodulatory Effects of Phlebotomy

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

Although phlebotomy is routinely performed in blood donors, and seemingly does not have significant health risks, it is highly relevant to know what the effect of phlebotomy is on immunity. Alterations in immunity due to phlebotomy could have beneficial effects, like the suppression of the low grade inflammatory process that contributes to atherosclerosis, but in theory could also contribute to a suppressed innate immune response that could increase the risk of infection. This is not only relevant for blood donors, but also for patients suffering from blood loss and for daily clinical practice in which blood is routinely drawn of patients for laboratory determinations.

NCT ID: NCT02031458 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

BIRCH
Start date: January 22, 2014
Phase: Phase 2
Study type: Interventional

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

NCT ID: NCT02031341 Completed - Clinical trials for Type 2 Diabetes Mellitus

Peripheral Insulin Uptake in Type 2 Diabetes Mellitus and in Non-Diabetic Individuals

PEAKS
Start date: January 2014
Phase: N/A
Study type: Observational

Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus. It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle interstitium plays a role in this process. We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes mellitus.