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NCT ID: NCT01477528 Completed - Anticoagulation Clinical Trials

Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)

TRACE
Start date: November 2011
Phase:
Study type: Observational

The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.

NCT ID: NCT01477203 Completed - Anxiety Disorder Clinical Trials

Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

MAN-BIOPSY
Start date: November 2011
Phase: Phase 4
Study type: Interventional

MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks. The main objectives of MAN-BIOPSY are therefore - to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and - to identify predictive markers for treatment response and type/severity of side effects for these disorders.

NCT ID: NCT01476423 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Start date: January 2004
Phase: N/A
Study type: Observational

This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA). The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.

NCT ID: NCT01476033 Completed - Inflammation Clinical Trials

Strong Women Study

Start date: October 2011
Phase: N/A
Study type: Interventional

The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice powder concentrate on oxidative stress, inflammation and blood flow before and post exercise in overweight, middle-aged, women. Main hypotheses (H1): - The nutraceutical has an impact on oxidative stress reduction. - The nutraceutical has an impact on inflammation. - The nutraceutical has an impact on blood flow and microcirculation. - Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers. - Walking exercise for 30 minutes has an impact on blood flow and microcirculation - The combination of nutraceutical supplementation + walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers, and on blood flow/microcirculation.

NCT ID: NCT01475838 Completed - HIV Infections Clinical Trials

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

NCT ID: NCT01475721 Completed - Asthma Clinical Trials

SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

AUSTRI
Start date: November 18, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

NCT ID: NCT01475669 Completed - Surgical Blood Loss Clinical Trials

Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery

REPLACE
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine. The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.

NCT ID: NCT01475344 Completed - Trauma Clinical Trials

Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)

Start date: September 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Severe traumatized patients with visible significant bleeding and/or with clinical signs of internal significant bleeding treated by an emergency doctor of the helicopter service or the ground team will be enrolled in the study (inclusion- and exclusion criteria: see above). If a patient meets the inclusion criteria and is recruited for the study, FGTW or placebo administrated over 5 min/vial: Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml) Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g

NCT ID: NCT01474629 Completed - Inflammation Clinical Trials

Probiotic Sport Study

Start date: October 2011
Phase: N/A
Study type: Interventional

We investigate the impact of a probiotic-based dietary supplement on oxidative stress and endotoxemia before and after strenuous exercise. Hypotheses (H1): - Supplementation has an influence on oxidative stress parameters before and post exercise - Supplementation has an influence on parameters of endotoxemia and inflammation before and post exercise - Strenuous exercise has an influence on parameters of oxidative stress, inflammation and endotoxemia

NCT ID: NCT01474603 Completed - Diabetes Clinical Trials

Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients

IMPEDE-DM2
Start date: November 2011
Phase: N/A
Study type: Observational

Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched diet with low glycemic index to overweight and obese patients with insulin resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and all other patients, respectively.