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NCT ID: NCT01140581 Completed - Atrial Fibrillation Clinical Trials

Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation

ARTEMIS Load
Start date: September 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: - Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: - Evaluate the rate of AF recurrences two months after randomization. - Assess the safety of the change from amiodarone to dronedarone - Assess dronedarone safety - Explore dronedarone and its active metabolite plasma level (in a subset of countries) - Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

NCT ID: NCT01140451 Completed - Cystic Fibrosis Clinical Trials

Extension Study of Ataluren (PTC124) in Cystic Fibrosis

Start date: August 12, 2010
Phase: Phase 3
Study type: Interventional

Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.

NCT ID: NCT01140347 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib

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

This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study. Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm. Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.

NCT ID: NCT01140243 Completed - Premature Infants Clinical Trials

Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

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

The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.

NCT ID: NCT01139710 Completed - SARCOIDOSIS Clinical Trials

Sarcoidosis-associated Pulmonary Hypertension

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

This prospective study was conducted to explore clinical characteristics and outcomes of patients diagnosed with pulmonary sarcoidosis and PH. The investigators also assessed the role of D -dimer levels in these population.

NCT ID: NCT01139697 Completed - Clinical trials for Systolic Heart Failure

Hair Cortisol and Testosterone in Heart Failure

Start date: August 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether hair cortisol and testosterone levels correlate with heart failure status in patient with chronic congestive heart failure.

NCT ID: NCT01139684 Not yet recruiting - Healthy Clinical Trials

Development of Field Test for Assessing the Human Anaerobic Capability

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

A test of the validity of repeated sprint test (RST) 4x 30 meters, against the Wingate Anaerobic Test, which is the gold standard for measuring human anaerobic capacity. The following variables will be used: peak power, mean power and fatigue index. In addition, it will be tested against a 50 meter and a 200 meter shuttle run.

NCT ID: NCT01139632 Active, not recruiting - Clinical trials for Coronary Artery Disease

The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease

0030-10
Start date: July 2010
Phase: N/A
Study type: Observational

The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.

NCT ID: NCT01139606 Completed - Muscle Strength Clinical Trials

Vibration Training and Muscle Strength Development

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

Introduction: Vibration has been used to enhance muscle strength development during resistance training. Aim: To assess the effect of adding vibration to a regular resistance training program, using free weights, on muscle strength and everyday functioning of upper limbs in untrained adults Methods: 60 healthy untrained adults, 30-65 yrs, will divide into two groups: experiment and control. Training program will include 24 sessions, over a course of 8 weeks. The experiment group will use a 1 kg vibrating weights and the control group will use a standard 1 kg free weights. Every session will include 10-15 min of 3-5 standard resistant exercises for upper limbs. Each subject will perform an Isokinetic evaluation of muscular performance, for upper limbs, in 3 occasions: before starting the program, immediately after completing the 8-weeks training program and 4 weeks afterwards, to check the chronic effect of each training regime. Each subject will complete a DASH (Disabilities of the arm, shoulder and hand) questionnaire at 4 occasions- as mentioned above and one more time, when completing the first 4 weeks of the training program, to reject any development of negative effects of the training program, such as pain or inflammation of the joints .

NCT ID: NCT01137812 Completed - Clinical trials for Diabetes Mellitus, Type 2

The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

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

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.