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NCT ID: NCT02240784 Completed - Clinical trials for Acute Hepatic Porphyria

EXPLORE: A Natural History Study of Acute Hepatic Porphyria (AHP)

Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to characterize the natural history and clinical management of Acute Hepatic Porphyria (AHP) patients with recurring attacks.

NCT ID: NCT02240680 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin as Add on to Basal Insulin in the Elderly

Start date: September 23, 2014
Phase: Phase 4
Study type: Interventional

To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed. In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.

NCT ID: NCT02240511 Completed - Heart Failure Clinical Trials

Resistance Exercise Program and Branched Chain Amino Acid Supplementation in Heart Failure Patients

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

Heart Failure (HF) is a complex syndrome which can include the physiological, neural hormonal and metabolic complications known as "Cardiac Cachexia" (CC). In the development of CC there is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and 6)that cause a decrease of fat free mass and fat mass. These changes in body composition might be reversed with a therapeutic combination of resistance exercise and branched chain amino acid supplementation (BCAA). Thus the purpose of this study is evaluate changes in body composition after a resistance exercise program and BCAA supplementation in patients with HF.

NCT ID: NCT02239120 Completed - Stroke Clinical Trials

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Start date: November 27, 2014
Phase: Phase 3
Study type: Interventional

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

NCT ID: NCT02235909 Completed - Hypertension Clinical Trials

An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension

Start date: December 19, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which is in the same class of drug and is approved for use in the pediatric population aged 6 years and older. Approximately 260 subjects will participate in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind, randomized, placebo-controlled withdrawal phase. A 44-week, open-label extension in which all subjects will receive azilsartan and other antihypertensive medications (if needed). Blood pressure will be assessed throughout the study.

NCT ID: NCT02235519 Recruiting - Obesity Clinical Trials

Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients

Start date: January 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to build a mathematical model to explain the effect of two doses of azilsartan (40 and 80 mg) upon metabolic (insulin resistance, glucose) and inflammatory parameters (cytokines) in function of "metabolic strata" like obesity, type 2 diabetes mellitus, hypertension and their combinations.

NCT ID: NCT02234843 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

EINSTEIN Jr
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

NCT ID: NCT02233985 Recruiting - Bronchiolitis Clinical Trials

Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

Start date: August 2013
Phase: Phase 4
Study type: Interventional

- Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis.

NCT ID: NCT02231749 Active, not recruiting - Clinical trials for Metastatic Renal Cell Carcinoma

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Start date: October 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

NCT ID: NCT02231242 Recruiting - Cerebral Palsy Clinical Trials

Intrathecal Stem Cells for Cerebral Palsy Phase II

ISCII
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the infusion of intrathecal autologous bone marrow total nucleated cells would improve the neurologic evolution of pediatric patients with quadriparetic cerebral palsy.