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NCT ID: NCT01461603 Active, not recruiting - Critical Illness Clinical Trials

Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg

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

Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%. Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR. Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB. Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.

NCT ID: NCT01451801 Active, not recruiting - Hepatitis B Clinical Trials

Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders

Start date: October 2011
Phase: Phase 4
Study type: Interventional

Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none or to few antibodies after a standard immunization with 3 vaccines. These individuals are defined as non-responders. The investigators wish to investigate if mounting another kind of immune response, called the cellular immune (CMI) response, protects these non-responders. Aim/Hypothesis Primary aims: 1. To estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization Secondary aims: 2. To establish the prevalence of serological non-responders after a standard course of HBV vaccination. 3. To assess the safety of the vaccine. 4. Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization 5. To compare the immunological profile before and after a standard HBV vaccination regimen on non-responders and responders 6. Establish a rapid test for measuring CMI after being HBV vaccinated. A total of 400 healthy volunteers receive a standard course of immunization with a combined hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Blood is drawn at 0 and 8 months from all participants. The blood will be analysed to see if there is antibodies or/and if there is mounted a cellular immune response by measuring on parameters called cytokines.

NCT ID: NCT01435408 Active, not recruiting - Clinical trials for ST Segment Elevation Myocardial Infarction

DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction

DANAMI-3
Start date: April 2011
Phase: N/A
Study type: Interventional

This study focuses on Cardioprotective strategies.

NCT ID: NCT01423500 Active, not recruiting - Clinical trials for Lymphoblastic Leukemia, Acute, Childhood;

ALL-SCT BFM International- HSCT in Children and Adolescents With ALL

ALL-SCT-BFMi
Start date: January 2007
Phase: Phase 3
Study type: Interventional

With this protocol the ALL-SCT BFM international study group wants - to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). - to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling donors or matched donors. - to determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. - to prospectively evaluate and compare the incidence of acute and chronic Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).

NCT ID: NCT01415596 Active, not recruiting - Clinical trials for Ergogenic Effects of Salbutamol in Healthy Males

The Effect of High Dose Salbutamol on Muscle Performance

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

Many athletes use beta2-agonists as treatment of airway hyperresponsiveness during exercise. High dose beta2-agonists may have an ergogenic effect on exercise performance. We hypotheis that the beta2-agonist, salbutamol, taken in high doses can improve muscle power and recovery during exercise in well-trained athletes.

NCT ID: NCT01401166 Active, not recruiting - Breast Cancer Clinical Trials

Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This randomized, open-label, crossover study evaluated participants' preference and healthcare professional satisfaction with trastuzumab (Herceptin) subcutaneous (sc) versus intravenous (iv) administration in participants with HER2-positive early breast cancer.

NCT ID: NCT01395719 Active, not recruiting - Acute Kidney Injury Clinical Trials

Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function

Context
Start date: June 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether remote ischemic conditioning can improve the outcome after renal transplantation with deceased donor. Remote ischemic conditioning is performed on the patient receiving a kidney from a deceased donor. Remote ischemic conditioning is done during the operation by inflating a tourniquet on the patients leg before opening the blood circulation to the kidney. The study focus on both the immediate kidney function after the transplantation, but also on the extended kidney function one year after the transplantation.

NCT ID: NCT01390688 Active, not recruiting - Clinical trials for Cognitive Dysfunction

Brain-derived Neurotrophic Factor and Cogntive Function

Start date: June 2009
Phase: N/A
Study type: Observational

Individuals with type 2 diabetes have an increased risk of developing cognitive dysfunction followed by dementia in late life. Obesity, physical inactivity and "systemic low-grade inflammation" are strong risk factors and play a crucial role in this network of diseases. Brain-derived Neurotrophic factor (BDNF) is produced in brain as well as several tissues outside brain eg muscle cells. Low BDNF are associated with cognitive dysfuction, obesity and type 2 diabetes. The investigators include 200 individuals divided into three groups: 80 individuals with type 2 diabetes, 80 age and BMI-matched controls and 40 individuals with impaired glucose tolerance. The project will test the hypothesis, that low systemic BDNF are associated with accumulation of abdominal fat, cognitive dysfunction and insulin resistence with different effect in men and women.

NCT ID: NCT01383304 Active, not recruiting - Clinical trials for Coronary Artery Disease

Aspirin Response in High Risk Patients With Coronary Artery Disease

Start date: November 2007
Phase: N/A
Study type: Observational

Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon "aspirin low-responsiveness". Laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown. The investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher risk of thrombosis. The purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (CAD) having a reduced biochemical response to aspirin compared with CAD patients having a normal biochemical response to aspirin. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.

NCT ID: NCT01358877 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

APHINITY
Start date: November 8, 2011
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).