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NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

ASOS
Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

NCT ID: NCT02932267 Completed - Acne Vulgaris Clinical Trials

Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne

EDeN
Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face. All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face. The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).

NCT ID: NCT02731885 Completed - Healthy Volunteers Clinical Trials

Food Effect on Pharmacokinetic Parameters of ABX464

Start date: September 2014
Phase: Phase 1
Study type: Interventional

The goal of this study is to determine the impact of the food on the absorption of the ABX464.

NCT ID: NCT02569710 Completed - Chronic Hepatitis C Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

Start date: October 31, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.

NCT ID: NCT02504645 Completed - Clinical trials for Lupus Erythematosus, Systemic

A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

LUPUZOR
Start date: March 2015
Phase: Phase 3
Study type: Interventional

This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.

NCT ID: NCT02452242 Completed - Clinical trials for Human Immunodeficiency Virus Infections

Safety, PK and PD Study of ABX464 in Untreated HIV Patients

Start date: January 2015
Phase: Phase 2
Study type: Interventional

ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV. Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.

NCT ID: NCT02197117 Completed - Clinical trials for ST-segment Elevation Myocardial Infarction (STEMI)

Effect of Remote Ischemic Conditioning in Heart Attack Patients

ERIC-LYSIS
Start date: March 2011
Phase: N/A
Study type: Interventional

New treatments are required to improve health outcomes in patients with ischemic heart disease. This is especially so in developing countries such as Mauritius in which optimal therapy for acute myocardial infarction may not be widely available. For example for patients presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the treatment of choice would be to remove the blockage by primary percutaneous coronary intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to keep the artery opened. However, PCI is not widely available in Mauritius and heart attack patients are given clot-busting therapy to remove the blockage, but this is not as effective as PCI. Therefore, in this research study we investigate a new cheap treatment that may help protect the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff a protective signal can be relayed to the heart to reduce the amount of damage occurring during the heart attack and thereby prevent the onset of heart failure. Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to the heart muscle during a heart attack..

NCT ID: NCT02016079 Completed - Aggressive Clinical Trials

Effect of Omega-3 Supplementation on Child Behavior Problems

Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.

NCT ID: NCT01928147 Completed - Clinical trials for Hepatitis C, Chronic

A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients

Start date: August 2013
Phase: Phase 1
Study type: Interventional

PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.

NCT ID: NCT01248143 Completed - Clinical trials for Assess the Effect of Green Tea on Diabetes

Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases

Start date: November 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Type 2 diabetes is common in ethnic and, minority groups in developing and developed countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya preparation and green tea infusates in latent diabetes (individuals newly diagnosed as diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation end-products which play a role as proinflammatory mediators in gestational diabetes can accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction with high-affinity receptors located on monocytes and macrophages can enhance the production of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial, mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of cardiovascular complications. The clinical markers include C-reactive proteins (inflammation indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides, and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of diabetic nephropathy. A second phase of the study is expected to commence after the first 16 weeks in order to assess the ability of the dietary factors to modulate atheroma formation and the integrity of drug therapy (upon commencement of treatment)on the prognosis of diabetes. This will be expected to last up to 3 years.