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NCT ID: NCT02384122 Completed - Anemia Clinical Trials

Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias

OCEAN
Start date: September 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether 40 mg octreotide long-acting release intramuscular every 28 days is effective in the treatment of patients with refractory anemia due to gastrointestinal angiodysplasias. We hypothesize that octreotide is effective in reducing the transfusion requirements (consisting of red blood cell transfusions and intravenous iron infusions) of patients with angiodysplasia-related anemia.

NCT ID: NCT02383927 Completed - Thyroid Cancer Clinical Trials

Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations

Start date: March 2015
Phase: Phase 2
Study type: Interventional

Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open

NCT ID: NCT02382718 Completed - Clinical trials for Food Allergy to Fish

FAST Fish Phase IIb Clinical Trial for the Treatment of Fish Allergy by Subcutaneous Immunotherapy

FASTIIb
Start date: October 2015
Phase: Phase 2
Study type: Interventional

This is a phase IIb clinical trial to investigate the efficacy and safety of subcutaneous immunotherapy with a modified parvalbumin called mCyp c 1 for the treatment of fish allergy to subjects allergic to fish.

NCT ID: NCT02381340 Completed - Obesity Clinical Trials

ACE Stapler Sub Study

Start date: June 2012
Phase: N/A
Study type: Observational

Obesity and its associated conditions have reached epidemic proportions. Estimates are that about one third of the adults in the United States have obesity. At this moment there are many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment options are limited and so far surgical intervention has been proven to be the only strategy to overcome severe obesity. However, bariatric surgery has limitations and risks, which might be minimized by non-incisional endoscopic procedures. BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM) Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which intends to reduce the ability of the stomach to expand by creating plications in the region of the fundus and greater curvature. In contrast with other bariatric surgery it is endoscopically performed, reversible and if it fails most future surgical options are still open. The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this plicating system for patients with severe obesity. In this sub-study the investogators want to unravel the exact mechanism and provide more information about the efficacy of the BaroSense ACE™ Stapler. Therefore the authors will measure changes in various parameters that are known to affect weight loss and metabolism, before and after gastric plication (by using the BaroSense ACE™ Stapler) in overweight subjects (these parameters will only be measured in patients at MUMC+). These parameters are post-prandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, satiety hormone release, microbiota composition and inflammatory markers. Objectives: Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, hormone release, microbiota composition and inflammatory markers.

NCT ID: NCT02381145 Completed - Healthy Clinical Trials

Dietary Polyphenols and Insulin Sensitivity in Overweight and Obese Humans

Start date: August 2012
Phase: N/A
Study type: Interventional

In this double-blind, randomized, placebo-controlled study, we aim to investigate the effects of a long-term supplementation on insulin sensitivity, mitochondrial function and substrate metabolism in healthy overweight men and women. In each group, 21 subjects consume 100mg Resveratrol (RSV) and 150mg Epigallocatechin-gallate (EGCG), respectively Placebo capsules, twice daily over a period of 12 weeks. The subjects receive the capsules after the last pre-measurement and continue to take them throughout the post-measurements. Before and after the supplementation period, we perform a hyperinsulinemic-euglycemic clamp with a glucose-tracer infusion to assess hepatic and systemic insulin sensitivity. Simultaneously, substrate oxidation is measured throughout the clamp by indirect calorimetry. Furthermore, we perform a high-fat mixed meal test, in which we collect blood and measure substrate oxidation during fasted and postprandial conditions. During the meal tests, extra plasma is collected at the start (t=-30) and the end (t=240), of which the supernatant is stored in light-protected tubes (EGCG is mixed 1:1 with an EGCG buffer) for analyzing polyphenol concentrations in the blood. In the male subgroup (21 men), we additionally place each 2 microdialysis probes in the subcutaneous adipose tissue and the gastrocnemius in order to assess local lipolysis and blood flow by means of ethanol infusion. Furthermore, a dexa-scan is performed to assess body composition and biopsies are taken under fasted conditions from the subcutaneous adipose tissue and the quadriceps femoralis muscle. These samples are stored at -80C. Part of the adipose tissue samples is collected to measure adipocyte size. Of the skeletal muscle biopsy, one part is directly buffered and used for the oxygraph to measure mitochondrial function. At last, feces samples are collected before and after the intervention in order to assess energy content, microbial composition and short-chain fatty acid content. Based on previous human studies in our and other departments, we hypothesize that after 12 weeks of the combined polyphenol supplementation, insulin sensitivity and mitochondrial function improve. Furthermore, based on results of a short-term study performed by our group, that demonstrated an increase in energy expenditure, a positive effect on the regulation of body composition might be expected.

NCT ID: NCT02381119 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of Personalized Dietary Advice on Health Status of Diabetes Type 2 Patients

PDA(4)T2D
Start date: May 2015
Phase: N/A
Study type: Interventional

This study addresses the challenge of increasing compliance with dietary recommendations and guidelines among diabetes type 2 patients by introducing professional dietary advice based on individual requirements. The objective of this study is to assess the effect of the Personalized Dietary Advice Services (PDAS) after a three month intervention on established markers of nutritional and health status in diabetes type 2 patients (HbA1c, glucose, insulin). Besides, the effect of the PDAS on perceived health status of diabetes type 2 patients will be assessed.

NCT ID: NCT02378948 Completed - Clinical trials for Esophageal Neoplasms

Nutritional Route In Esophageal Resection Trial II

NUTRIENTII
Start date: October 2015
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of early start versus delayed start of oral intake on postoperative functional recovery after an esophagectomy.

NCT ID: NCT02378844 Completed - Migraine Clinical Trials

A Randomized, Sham-controlled Study of gammaCore ® (nVNS) for Prevention of Episodic Migraine

Start date: June 2015
Phase: N/A
Study type: Interventional

A prospective, double-blind, randomized, sham-controlled, multicentre investigation.

NCT ID: NCT02378688 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are: - To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD) - To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

NCT ID: NCT02378532 Completed - Clinical trials for Glioblastoma Multiforme

The Addition of Chloroquine to Chemoradiation for Glioblastoma

CHLOROBRAIN
Start date: August 2016
Phase: Phase 1
Study type: Interventional

Patients with a glioblastoma (GBM) have a poor prognosis with a median survival of 14.6 months after maximal treatment with a resection and chemoradiation. Since the pivotal trial evaluating the effect of temozolomide (TMZ), overall survival has not increased. Treatment of GBM xenografts in vivo with chloroquine (CQ), an antimalarial agent, has been shown to reduce the hypoxic fraction and sensitizes tumors to radiation. Epidermal growth factor receptor (EGFR) amplification or mutation is regularly observed GBM and is thought to be a major contributor to radioresistance. The most common EGFR mutation in GBM (EGFRvIII) is present in 50-60% of patients whose tumor shows amplification of EGFR. EGFR provides cells with a survival advantage through autophagy when exposed to stresses such as hypoxia and nutrient starvation. This effect is even more pronounced in EGFRvIII overexpressing tumors. Previously, the potential effect CQ has been demonstrated in a small randomized controlled trial in GBM treated with radiotherapy and carmustine, which showed a trend towards increased overall survival. However, as the intracellular effects of chloroquine are dose-dependent the maximum tolerated dose for CQ in combination with concurrent radiotherapy with daily temozolomide needs to be established.