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NCT ID: NCT00765063 Completed - Diabetic Foot Ulcer Clinical Trials

The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

Start date: October 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.

NCT ID: NCT00764881 Completed - Contraception Clinical Trials

Effects of SH T00658ID on Libido

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

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

NCT ID: NCT00764621 Completed - Clinical trials for Colorectal Neoplasms

Health Economic Evaluation of Primovist-enhanced Liver MRI

Start date: October 2008
Phase: Phase 4
Study type: Interventional

Patients with a history of colorectal cancer and known or suspected liver metastases who are scheduled for contrast-enhanced tomographic imaging will be included in this study. After randomization to either Primovist-enhanced MRI, extracellular contrast media (ECCM)-enhanced MRI or contrast-enhanced (CE)-CT outcomes and resource needs of the diagnostic work-up and treatment will be evaluated for each of the three imaging modalities. Main objectives of the study are to assess the proportion of patients for whom further imaging is required to come to a therapy decision and to evaluate the proportion of patients with intraoperatively modified surgical plans after Primovist-enhanced MRI as compared to ECCM-enhanced MRI and CE-CT.

NCT ID: NCT00763815 Completed - Clinical trials for Diabetes Mellitus Type 2

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

GETGOAL-P
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

NCT ID: NCT00761787 Completed - Heart Disease Clinical Trials

Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

CARGOII
Start date: May 2005
Phase: N/A
Study type: Observational

The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.

NCT ID: NCT00761475 Completed - Clinical trials for Incisional Hernia Occurence

Primary Mesh Closure of Abdominal Midline Wounds

PRIMA
Start date: February 2009
Phase: Phase 3
Study type: Interventional

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.

NCT ID: NCT00760760 Completed - Morbid Obesity Clinical Trials

n-3 Polyunsaturated Fatty Acids in Obesity

PUFA-ATI
Start date: September 2008
Phase: Phase 2
Study type: Interventional

Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.

NCT ID: NCT00759629 Completed - Clinical trials for Myocardial Infarction

Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial

Brave-2
Start date: May 2001
Phase: Phase 4
Study type: Interventional

The objective of this international, multicenter, randomized study is to assess whether coronary artery stenting is associated with a reduced infarct size in patients with AMI presenting between 12 and 48 hours after onset of symptoms compared to medical treatment alone

NCT ID: NCT00757536 Completed - Clinical trials for Rhegmatogenous Retinal Detachment

Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment

Start date: May 2006
Phase: N/A
Study type: Interventional

Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.

NCT ID: NCT00757471 Completed - Clinical trials for Idiopathic Macular Holes

Brillant Blue Versus Indocyanine Green for Macular Hole Surgery

Start date: August 2008
Phase: N/A
Study type: Interventional

Macular Hole Surgery with two different Dyes