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NCT ID: NCT01654653 Completed - Clinical trials for Coronary Heart Disease

Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients

Start date: July 2008
Phase: Phase 4
Study type: Interventional

The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids. Several previous studies have demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL with 6% Hydroxy Ethyl Starch (HES).

NCT ID: NCT01646437 Completed - Clinical trials for Cardiovascular Disease

The International Polycap Study 3 (TIPS-3)

TIPS-3
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The randomized 2x2x2 factorial design placebo controlled trial will enroll 5000 participants (women 60 years or older and men 55 years or older) without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. Eligible and consenting individuals will be randomized to receive either the active study medications or placebo (dummy pills) and will be monitored for an average of 5 years. The study will include people from at 10 countries, will be conducted by an international group of scientists and physicians and will be coordinated by the Population Health Research Institute at Hamilton Health Sciences.

NCT ID: NCT01645332 Completed - Clinical trials for Type-2-diabetes Mellitus

Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

Start date: July 2012
Phase: Phase 3
Study type: Interventional

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

NCT ID: NCT01633398 Completed - Heart Failure Clinical Trials

ASIAN HF Registry, A Prospective Observational Study

ASIANHF
Start date: September 2012
Phase:
Study type: Observational

The ASIAN HF Registry is the first prospective multinational Asian registry of patients with symptomatic HF (stage C) including both HFrEF (ejection fraction <40%) and HFpEF (ejection fraction ≥50%), with the broad purpose of determining the mortality (incidence) burden of HF in Asian patients, and more specifically to define the burden and risk factors of Sudden Cardiac Deaths (SCD), as well as the sociocultural barriers to preventive device therapy. The study further aim to study the genetic variants associated with HFrEF versus HFpEF in our large Asian cohort. This proposed registry is expected to advance fundamental understanding of the burden and predictors of preventable death among Asian patients with HF. The knowledge gained will be critical for guiding resource allocation and planning preventive strategies to address the unmet and growing clinical needs of patients with cardiovascular disease in Asia.

NCT ID: NCT01602055 Completed - Fasting Clinical Trials

A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd

NCT ID: NCT01597076 Completed - Quality of Life Clinical Trials

Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The objectives of this clinical trial are to evaluate the effectiveness of an iridoid enriched beverage containing noni and cornelian juices and olive leaf extract on advanced glycation end product levels.

NCT ID: NCT01594931 Completed - Clinical trials for Plasmodium Falciparum Malaria

Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria

Start date: July 2005
Phase: Phase 2
Study type: Interventional

The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.

NCT ID: NCT01589653 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

Start date: May 2012
Phase: Phase 4
Study type: Interventional

This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.

NCT ID: NCT01573403 Completed - Clinical trials for Gastric pH Regulation in Healthy Volunteers

Efficacy and Safety of DLBS2411 in Healthy Volunteers

Start date: April 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as well as its safety in healthy volunteers. DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is hypothetically more potential than PPIs in suppressing gastric acid as our previous preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+ ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).