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NCT ID: NCT01778049 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

Start date: January 2013
Phase: Phase 3
Study type: Interventional

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

NCT ID: NCT01777776 Completed - Clinical trials for Locally Advanced or Metastatic BRAF Mutant Melanoma

Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.

Start date: July 2013
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.

NCT ID: NCT01777620 Completed - Facial Rhytides Clinical Trials

A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides

Start date: January 31, 2013
Phase: Phase 4
Study type: Interventional

This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).

NCT ID: NCT01777334 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD

Start date: January 23, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.

NCT ID: NCT01777152 Completed - Clinical trials for Non-Hodgkin Lymphoma

ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas

ECHELON-2
Start date: January 31, 2013
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.

NCT ID: NCT01776944 Completed - Obesity Clinical Trials

Resting Energy Expenditure Using a Handheld Calorimeter

CalVal
Start date: May 2012
Phase: N/A
Study type: Observational

High prevalence of obesity in children has increased associated complications such as type 2 diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts caloric intake by estimating the resting and total daily energy expenditures.Estimation of energy needs is most commonly done using predictive equations. Reliable and valid energy requirements can be obtained using a traditional metabolic system, however this is an expensive option. Handheld indirect calorimeters may be a good alternative to measure energy needs. Several studies have been conducted to determine the validity and accuracy of handheld calorimeters in adults and health children, however, to the best of our knowledge, there are no such studies in the overweight and obese pediatric population. The purpose of this study is to validate a handheld indirect calorimeter against a traditional metabolic system in overweight and obese children. If handheld calorimeters can accurately measure resting energy expenditure in overweight and obese adolescents, dietitians will have an opportunity to tailor pediatric weight management interventions based on parameters that are unique to each individual.

NCT ID: NCT01776931 Completed - Pregnancy Clinical Trials

Determination of Lysine Requirements in Pregnancy

Start date: January 2012
Phase: N/A
Study type: Interventional

Amino acids are building blocks of protein in our body. It is important that pregnant women eat adequate amount of protein/amino acids to ensure healthy growth and development of the fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and not much in plant foods such as wheat. Currently , it is not known how much lysine is needed to eat during pregnancy. Current Dietary Reference Intake recommendations for amino acid requirements are based on non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators knowledge, there is no scientific information regarding the amount of lysine needed at different stages of pregnancy. The investigators hypothesize that current recommendations for lysine intake in pregnant women are underestimated. The investigators also hypothesize that the lysine requirements will be greater during the later stages of pregnancy, compared to early stages. The purpose of this study is to determine lysine requirements in healthy pregnant women 19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.

NCT ID: NCT01776918 Completed - Clinical trials for Mitochondrial Disease

Energy Requirements in Mitochondrial Disease

Start date: February 2012
Phase: N/A
Study type: Observational

Metabolic diseases and mitochondrial disorders are caused by genetic mutation which lead to disruptions in energy producing pathways in our body. Enough energy or calories must be given in the diet to ensure normal growth and development. Currently, energy needs for patients with metabolic and mitochondrial diseases are not measured, but is estimated using a mathematical equation based on healthy children. This may lead to under feeding or overfeeding of calories, and has negative nutritional implications. The clinical standard for measuring energy needs is the use of indirect calorimeter.The indirect calorimeter takes individualized measurements for each patient and therefore will enable dietitians and clinicians to provide sufficient calories in the diet to better manage the disease and promote normal growth and development. We believe daily energy requirements will vary within metabolic diseases (Phenylketonuria) and mitochondrial disorders (mitochondrial fatty acid oxidation defect, POLG1 mutation etc.). The objective of this preliminary study is to measure resting energy expenditure in children living with metabolic and mitochondrial conditions and data obtained will be used to generate future hypothesis and will form a basis for future studies.

NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

NCT ID: NCT01776372 Completed - Lung Neoplasms Clinical Trials

Comparison of Pleural Drainage Systems on Reducing Pleural Effusion Formation Following Lung Resection

Start date: January 2013
Phase: N/A
Study type: Interventional

The chest cavity contains a small amount of fluid (pleural effusion). In normal circumstances this fluid is kept in balance. When surgery is performed on the lung, there can be accumulation of more fluid due to many causes. In order to drain this additional amount of pleural fluid, chest tube(s) are left in the thoracic cage after a lung resection procedure. The investigators are attempting to reduce the amount of pleural fluid production and formation by using a more balanced thoracic drainage system, which adjusts the amount of suction depending on the needs of the patient. That way, the amount of inflammation in the thoracic cage might be smaller, and hence less fluid will be formed. By this, the investigators are hoping that the chest tubes can be removed earlier, and the patients can be discharged faster and will potentially have a lower rate of re-admission to the hospital after surgery due to problems related to the fluid in the thoracic cage.