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NCT ID: NCT00982644 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

BEGIN™
Start date: September 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial. The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

NCT ID: NCT00982397 Completed - Heart Failure Clinical Trials

Safety and Clinical Performance of the Protecta ICD and CRT-D

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

The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.

NCT ID: NCT00981942 Completed - Clinical trials for Nephrogenic Systemic Fibrosis

Treatment of Patients With Nephrogenic Systemic Fibrosis With Glivec

NSF
Start date: September 2009
Phase: Phase 3
Study type: Interventional

The investigators will study the effect of imatinib mesylate (Glivec) in treatment of moderate to severe nephrogenic systemic fibrosis (NSF). So far there is no evidence of adequately effective treatment options of NSF. Various treatments have been tried to stop the progressing disease. Corticosteroids, which suppress the early inflammatory stage of the disease, fail to halt disease progression. Other immunosuppressive agents, photopheresis, and kidney transplantations are reported to be partly beneficial to the patients. It has not been possible to confirm these findings in further studies because in photopheresis, and kidney transplantation, such effects are generally unreproducible.

NCT ID: NCT00980057 Completed - Heart Failure Clinical Trials

Adaptive Cardiac Resynchronization Therapy Study

aCRT
Start date: October 1, 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance

NCT ID: NCT00978913 Completed - Breast Cancer Clinical Trials

Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.

NCT ID: NCT00978627 Completed - Diabetes Clinical Trials

Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

BOOST™
Start date: August 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

NCT ID: NCT00978575 Completed - Anemia Clinical Trials

Iron Substitution After Upper Gastro-Intestinal Bleeding

Start date: April 2010
Phase: Phase 4
Study type: Interventional

The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.

NCT ID: NCT00977483 Completed - Clinical trials for Diabetic Polyneuropathy

Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)

NATHAN1
Start date: May 1998
Phase: Phase 3
Study type: Interventional

To assess clinical efficacy and safety of long-term orally administered thioctic acid in the treatment of diabetic polyneuropathy.

NCT ID: NCT00977080 Completed - Clinical trials for Chronic Kidney Disease

Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D

IMPACT SHPT
Start date: November 2009
Phase: Phase 4
Study type: Interventional

Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.

NCT ID: NCT00976911 Completed - Ovarian Cancer Clinical Trials

AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Start date: October 29, 2009
Phase: Phase 3
Study type: Interventional

This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.