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NCT ID: NCT01220141 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

Start date: November 2010
Phase: N/A
Study type: Observational

This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

NCT ID: NCT01219842 Completed - Clinical trials for Intermittent Claudication

Invasive Revascularization or Not in Intermittent Claudication

IRONIC
Start date: March 2010
Phase: N/A
Study type: Interventional

Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health Technology Assessment Report identified only limited evidence for the effectiveness of invasive treatment for IC in patients already on exercise training. The prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. Invasive treatment can also cause serious complications. Coronary artery disease is common in IC patients increasing the risk with invasive treatment. In spite of these uncertain merits and potential risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in addition to BMT improves health related quality of life and walking performance compared to BMT only.

NCT ID: NCT01219400 Completed - Diabetes Clinical Trials

Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore whether the novel therapy of type 2 diabetes, vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.

NCT ID: NCT01217671 Completed - Emphysema Clinical Trials

International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema

Start date: December 2009
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema caused by Alpha-1 Antitrypsin (AAT) deficiency.

NCT ID: NCT01217476 Completed - Clinical trials for Diabetic Foot Ulcer of Neuropathic Origin

The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study

TRANS-North
Start date: December 2010
Phase: Phase 3
Study type: Interventional

Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product. We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 40 investigational sites in Europe.

NCT ID: NCT01216709 Completed - Infant Clinical Trials

Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)

MJAU
Start date: October 2010
Phase: N/A
Study type: Interventional

Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.

NCT ID: NCT01216202 Completed - Rectal Cancer Clinical Trials

Sexual Function and Wellbeing in Males With Rectal Cancer

Start date: April 2010
Phase:
Study type: Observational

Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. For men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where measurements of androgen hormone levels, semen samples and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

NCT ID: NCT01216189 Completed - Rectal Cancer Clinical Trials

Sexual Function and Wellbeing in Females With Rectal Cancer

Start date: June 2008
Phase:
Study type: Observational

Preoperative radiotherapy (RT) and pelvic surgery is recommended to many patients with rectal cancer. For women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where androgen levels and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

NCT ID: NCT01216033 Completed - Breast Cancer Clinical Trials

Exploratory Study of Breast Cancer With ABY025

ABY0125
Start date: October 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding molecule 111-In-ABY025 and if that shows whether the metastases express HER2.

NCT ID: NCT01215747 Completed - Amyloidosis Clinical Trials

Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.