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NCT ID: NCT01243424 Completed - Clinical trials for Diabetes Mellitus, Type 2

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

Start date: November 11, 2010
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

NCT ID: NCT01242917 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy

CARAT-2
Start date: September 2010
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.

NCT ID: NCT01242852 Completed - Clinical trials for Intrauterine Abnormalities in Infertility

SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle

inSIGHT
Start date: May 2011
Phase: Phase 4
Study type: Interventional

BACKGROUND: Despite the numerous advances in the field of in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum implantation rate per embryo transferred of about 30%. Next to the physiological and physic burden that comes with every IVF treatment cycle, implantation failure also adds up to the considerable costs associated with ART. Studies have shown, that minor intrauterine abnormalities can be found in 11-40% of the infertile women with a normal transvaginal sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all infertile women on intracavitary pathology prior to the start of IVF/ICSI. OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the fertility treatment. STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women, indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography. INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up. In both groups standard IVF/ICSI treatment will be initiated. PRIMARY OUTCOME MEASURE: Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles) SECONDARY OUTCOME MEASURE: - Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles) - Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles) - Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment - Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure - Prevalence of unexpected intrauterine abnormalities - Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities

NCT ID: NCT01242748 Terminated - Prostate Cancer Clinical Trials

A Degarelix Trial in Patients With Prostate Cancer

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

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

NCT ID: NCT01242527 Completed - Clinical trials for Severe Hypertriglyceridemia

Epanova® for Lowering Very High Triglycerides

EVOLVE
Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.

NCT ID: NCT01241890 Completed - Quality of Life Clinical Trials

Prevention of CF Exacerbation in Childhood: PREVEC Study

PREVEC
Start date: October 2011
Phase: N/A
Study type: Observational

Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.

NCT ID: NCT01241877 Recruiting - Clinical trials for Athletic Performance

Astaxanthin Supplementation in Cyclists

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

Background of the study: Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in animals and humans. Exercise enhancing effects have been shown in animals via enhancement of fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on fat oxidation and cycling performance in trained cyclists Objective of the study: To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat oxidation and improve exercise performance in trained cyclists Study design: Double blind, placebo controlled study. Study population: Well trained cyclists between 18-30 years old Intervention (if applicable): astaxanthin (20 mg/day) or placebo for 4 weeks Primary study parameters/outcome of the study: performance on a time trial after 90 min steady state exercise. Secundary study parameters/outcome of the study (if applicable): substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): The risks involved in participating in this experiment are minimal. Astaxanthin has been shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is of a small local haematoma.

NCT ID: NCT01241682 Completed - Clinical trials for Malignant (Pleural) Mesothelioma

Dendritic Cell-based Immunotherapy Combined With Low-dose Cyclophosphamide in Patients With Malignant Mesothelioma

PMR-MM-002
Start date: October 2009
Phase: Phase 1
Study type: Interventional

Earlier the investigators determined the safety and feasibility of tumor lysate-pulsed dendritic cells as therapeutic adjuvants in mesothelioma patients. Because pre-clinical data in mice had shown that better results were obtained when regulatory T cells were depleted using low-dosis of cyclophosphamide, ten patients who responded on chemotherapy are selected for DC-treatment in combination with Endoxan.

NCT ID: NCT01241591 Completed - Psoriasis Clinical Trials

A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

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

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

NCT ID: NCT01241201 Completed - Inflammation Clinical Trials

Intestinal Barrier Function and Probiotics.

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

Rationale: Enterotoxigenic Escherichia coli (ETEC) bacteria adhere to the mucosa of the proximal intestines. There it produces an toxin which presents a local and relevant challenge to the intestines. This is proposed to give an indication of general resistance and/or the local resistance of the intestines. The sequel of events of mucosal inflammation will be characterized in this study. In addition we will evaluate the effects of probiotics by comparing the infection symptoms and by measuring faecal weight and mucus in faeces. Objective: The main objective of this study is to investigate the effect of probiotics on the sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as total faecal output, relative faecal dry weight and mucin excretion in faeces. In addition, the sequels of the mucosal inflammation will be characterized and biomarkers will be searched.