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NCT ID: NCT00184886 Completed - Vasodilation Clinical Trials

The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans

Start date: November 2003
Phase: N/A
Study type: Interventional

In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation, ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by adenosine receptor stimulation. In this study, we aim to determine whether also in humans in vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial artery is assessed as biomarker for the endogenous adenosine concentration. Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn homocysteine.

NCT ID: NCT00184873 Completed - Leg Ulcers Clinical Trials

Legtest Multi Centre Testing of the Lively Legs Program for Promoting Compliance in Leg Ulcer Patients

Start date: January 2005
Phase: N/A
Study type: Interventional

Leg ulcers are often chronic or recurring complications of peripheral circulation disorders. Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. Especially exercise and compliance with compression therapy are key elements in the course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary lifestyles and non-compliance and current practice offers no systematic approach in the promotion of compliance and physical activity in these patients. The purpose of the study is testing 'Lively Legs' a compliance promotion program for patients with leg ulcers. The study tests the program on effects regarding: - compliance with compression therapy and exercise levels - time to leg ulcer recurrence - cost effectiveness from a social perspective.

NCT ID: NCT00184860 Completed - Clinical trials for Head and Neck Neoplasms

The Role of CT-PET-MRI Image Fusion in Determining Radiation Treatment Volumes of Head-and-Neck Cancer Patients

Start date: June 2003
Phase: N/A
Study type: Interventional

Technical developments in radiation oncology are making it possible to deliver a prescribed radiation dose to radiation target volume with increasing accuracy. Therefore it is becoming even more relevant to accurately define the radiation target volumes. The current standard in defining radiation target volumes in patients with head-and-neck cancer is to combine physical examination data with a CT-scan in the treatment position. The goal of this investigation is to analyse the rol of CT-PET-MRI image fusion in defining radiation target volumes.

NCT ID: NCT00184834 Completed - Quality of Life Clinical Trials

Quality of Life and Liver Metastases

Start date: June 1999
Phase: N/A
Study type: Observational

An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. The aim of this prospective study is to investigate the impact of surgery on health-related quality of life in this specific patient population operated for colorectal liver metastases.Furthermore, as the indications for hepatic resection are broadened and patients with more extensive liver disease are operated on, the chance of non operable disease at laparotomy will increase. The effects of such an event on HRQol are also studied.

NCT ID: NCT00184821 Completed - Clinical trials for Ischemia-Reperfusion Injury

Ischemic Injury and Ischemic Preconditioning in Diabetes

Start date: June 2004
Phase: N/A
Study type: Observational

In this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short period of ischemia that protects against subsequent ischemic exercise). Annexin A5 scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that results from ischemic exercise. The following hypotheses are tested: 1. Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared with previously studied healthy volunteers. 2. Ischemic preconidtioning is still present in patients with type 1 diabetes. Depending on the validity of hypothesis 2, the effect of short pharmacological interventions are studied on vulnerability to forearm ischemia/reperfusion injury in the absence or presence of local forearm ischemic preconditioning.

NCT ID: NCT00184574 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes

Start date: April 2005
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

NCT ID: NCT00182819 Completed - Clinical trials for Brain and Central Nervous System Tumors

Radiation Therapy or Temozolomide in Treating Patients With Gliomas

Start date: July 2005
Phase: Phase 3
Study type: Interventional

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.

NCT ID: NCT00182312 Completed - Clinical trials for Apnea of Prematurity

Caffeine for Apnea of Prematurity (CAP)

Start date: October 1999
Phase: Phase 3
Study type: Interventional

At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity. Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.

NCT ID: NCT00181545 Completed - Clinical trials for Non-Small-Cell Lung Carcinoma

Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients.

Start date: December 2004
Phase: Phase 1
Study type: Interventional

Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the local control rate is low and the radiation often causes pneumonitis and/or esophagitis. To predict to lung damage the mean lung dose can be calculated. This allows us to give a higher total dose to the tumor and to improve the local control rate. Study hypothesis: It will be safe to administer a radiation dose as high as possible to the tumor, taking into account the mean lung dose, calculated by the treatment planning system.

NCT ID: NCT00181532 Completed - Clinical trials for Non Small Cell Lung Carcinoma

Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC

Start date: May 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of the adminstration of celecoxib, a cox2-inhibitor in patients with stage II-III non small cell lung cancer receiving radical radiotherapy. The hypothesis is that celecoxib will increase the remission rate of radiotherapy.