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NCT ID: NCT00817284 Completed - Clinical trials for Glioblastoma Multiforme

Bevacizumab and Irinotecan or Bevacizumab and Temozolomide With Concomitant Radiotherapy for Primary Glioblastoma Multiforme (GBM)

Start date: November 2008
Phase: Phase 2
Study type: Interventional

Significant activity (radiographic response rates of approximately 60%) has recently been demonstrated in phase II studies in patients with relapsed GBM from the combined use of Irinotecan (CPT-11) and bevacizumab. The 6-month progression-free survival rate is 30% and median survival duration is 9 months. The current first line therapy of GBM patients following initial surgical resection/debulking is the concomitant use of cerebral radiotherapy and the orally available alkylating agent temozolomide, followed by temozolomide for 6 months post-radiotherapy. Considering the significant activity of the combination of Bevacizumab + irinotecan in patients with recurrent GBM, and considering the activity of temozolomide in GBM, it is proposed that the combination of Bevacizumab + Temozolomide may also be an active regimen. Bevacizumab + Temozolomide display non-overlapping toxicity clinically and thus their combined use without significant dose-reductions seems rational. The toxicity from the combined use of the two drugs prior to radiotherapy, as well as the toxicity when administered together with radiotherapy, is evaluated. This study will try to identity whether Bevacizumab and Irinitecan or Bevacizumab and Temozolomide should be the experimental arm in future phase III comparison with standard care with concomitant Temozolomide and radiotherapy.

NCT ID: NCT00816049 Completed - Clinical trials for Acute Lymphoblastic Leukemia

ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy

ALL2008con
Start date: January 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.

NCT ID: NCT00815698 Completed - Inguinal Hernia Clinical Trials

Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

Dangrip
Start date: December 2008
Phase: N/A
Study type: Interventional

The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.

NCT ID: NCT00815503 Completed - Pain Clinical Trials

Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy

Start date: January 2009
Phase: Phase 4
Study type: Interventional

Pain treatment after periacetabular osteotomy is traditionally based on systemic opioids wich have side effects. The purpose of this study is to evaluate the analgetic effect of wound infiltration with local anaesthesia after periacetabular osteotomy.

NCT ID: NCT00812903 Completed - Neck Pain Clinical Trials

Neck Pain in Danish Military Pilots and Flight Crew

Start date: March 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the prevalence of neck and shoulder pain in Danish fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a 24 weeks exercise intervention for fighter pilots.

NCT ID: NCT00812578 Completed - Type 2 Diabetes Clinical Trials

Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

ProjectD
Start date: December 2008
Phase: Phase 2
Study type: Interventional

The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.

NCT ID: NCT00810823 Completed - Type 2 Diabetes Clinical Trials

The Effect of Gastric Bypass Surgery on the Glucose Metabolism Seen in Patients With Type 2 Diabetes

Start date: January 2009
Phase: N/A
Study type: Observational

Gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early as 1 - 2 days after surgery and this is before any real weight loss has occurred. This suggest that the remission of the diabetes is due to the direct effect of the operation more that the secondary effect of the weight loss. The reason for the major effect on the glucose metabolism after gastric bypass surgery is still unaccounted for. This PhD. project will try to unveil some of the mechanisms that could explain the effect of gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes. The hypothesis of the study is that a factor "X" will course the remission of the diabetes. This factor "X" is related to the anatomic changes of the gastro intestinal tract, by eliminating the foods passage through the distal part of the ventricle and the duodenum, in combination with the Roux- en-Y sling. The PhD. project will consist of clinical trails on patients that will undergo gastric bypass surgery. The studies will take place before and within the 1. week after surgery. The investigators will measure different hormones and adipokines in fast and the postprandial state. To discover possible new proteins the investigators will run proteomic on some samples. All the results will be compared to the same parameter on patients undergoing gastric banding, where the anatomy of the intestine hasn't been changed.

NCT ID: NCT00810693 Completed - Clinical trials for Pulmonary Hypertension

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)

PATENT-1
Start date: December 17, 2008
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

NCT ID: NCT00810420 Completed - Type 1 Diabetes Clinical Trials

EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes

Start date: February 2007
Phase: N/A
Study type: Observational

The aim of this study is based on recent pilot studies carried out at Odense University Hospital showing that the acute changes in electroencephalographic (EEG) signals (i.e. electrical activity inthe brain) elicited by insulin-induced hypoglycemia in patients with type 1 diabetes can be reliable detected by real-time processing of these EEG signals using mathematical algorithms and state of the art noise and artifact reduction. These preliminary results also showed that the hypoglycemia-induced EEG changes are detectable 15-30 min before deterioration in cognitive function impedes an adequate response to warning. We hypothesize that these observations apply to the majority of patients with type 1 diabetes, and therefore, that it is possible to develop an automated device to detect hypoglycemic episodes by continuous real-time monitoring and processing of EEG signals. To test our hypothesis, the specific aims of the present proposal are: 1. Detection of hypoglycemia-induced EEG changes using subcutaneous electrodes 2. Ambulatory EEG monitoring using subcutaneous electrodes

NCT ID: NCT00810199 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

Start date: March 2009
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.