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NCT ID: NCT02049138 Completed - Clinical trials for Rheumatoid Arthritis

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

BALANCE-EXTEND
Start date: January 24, 2014
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.

NCT ID: NCT02047799 Completed - High Blood Pressure Clinical Trials

Effect of Vitamin D Supplementation on Blood Pressure in Elderly People

Start date: April 2013
Phase: Phase 2
Study type: Interventional

The prevalence and incidence of cardiovascular disease (such as Hypertension) increases exponentially with age (McDermott, 2007;) These diseases account for 30% of the global mortality (WHO, 2011). Vitamin D (VD) insufficiency affects as many as half of otherwise healthy adults in developed countries (Holick, 2007). VD is implicated in the control of blood pressure (BP) through inhibition of the renin-angiotensin system (Yamshchikov, 2009), although the role of VD supplementation for prevention and treatment of the HTA is controversial.The purpose of this study was to investigate if VD supplement in elderly people reduces the levels of BP.

NCT ID: NCT02047240 Completed - Liver Cirrhosis Clinical Trials

Renal Function Determination in Patients With Liver Cirrhosis

Start date: April 2013
Phase: N/A
Study type: Observational

We have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin C, because of its nature could improve diagnostic accuracy to determinate the renal function in this population. The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99 (diethylene-triamine-pentaacetate- technetium-99) as gold standard.

NCT ID: NCT02046369 Completed - Clinical trials for Bipolar I Depression

Lurasidone Pediatric Bipolar Study

Illuminate
Start date: March 2014
Phase: Phase 3
Study type: Interventional

A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

NCT ID: NCT02045862 Completed - Overactive Bladder Clinical Trials

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

SYNERGY II
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

NCT ID: NCT02042144 Completed - Neoplasms Clinical Trials

Safety and Effectiveness of Regorafenib

Correlate
Start date: April 8, 2014
Phase: N/A
Study type: Observational

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.

NCT ID: NCT02041533 Completed - Clinical trials for Stage IV or Recurrent Non-Small Cell Lung Cancer

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

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

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

NCT ID: NCT02041520 Completed - HIV/AIDS Clinical Trials

Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients

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

Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in the prevention of complications in seropositive for HIV patients. However, they develop some manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing cardiovascular risk. Clinical trials in general population and in patients on hemodialysis have demonstrated a significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially triglycerides. Also in general populations it has been described a benefit effect of omega 3 acids on oxidative stress. Objective: to know the effect of omega 3 acids on different markers of oxidative stress in seropositive HIV patients. Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid peroxidation products) will be evaluated. Sample size was calculated according to different variables. We selected the biggest one calculated for a difference in nitric oxide of 25% after treatment between groups and a standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of 31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost, a sample size of 35 per group was considered.

NCT ID: NCT02041351 Completed - Clinical trials for Metastatic Breast Cancer

Biweekly Docetaxel in Patients With Metastatic Breast Cancer.

Start date: November 2013
Phase: Phase 2
Study type: Interventional

There is clinical benefit of docetaxel administered to patients who have progressed to 3 or more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic responses are obtained that it never received taxanes.

NCT ID: NCT02040766 Completed - Asthma Clinical Trials

A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma

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

This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo. Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed) from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or placebo device for a total of 2 inhalations each time.