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NCT ID: NCT01788163 Completed - Clinical trials for EGFR Mutation Status in aNSCLC Patients

Asia Pacific and Russia Diagnostic Study for EGFR Testing

IGNITE
Start date: February 27, 2013
Phase: N/A
Study type: Interventional

Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.

NCT ID: NCT01786798 Recruiting - Clinical trials for Abnormal Uterine Bleeding

Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Start date: February 2013
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the role of transvaginal ultrasound in detecting endometrial hyperplasia and endometrial cancer in women aged more than 35 presenting with abnormal uterine bleeding.

NCT ID: NCT01785927 Unknown status - Healthy Clinical Trials

The Safety of Tuberculosis Treatments by Oral Inhalation

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

The inhaled route of delivery has always been associated with the considerable challenge of getting the drug to its target. The lungs are a highly complex organ designed to filter inspired air, with many different cell types contributing to their function. Furthermore, the lungs may change dramatically when afflicted by disease resulting in an internal environment that works against the drug reaching and interacting successfully with the target. For targets in the upper airways this will have lesser significance, but drug delivery to the deep lung may be impeded by changes such as mucus hyper-secretion or thickening or airway narrowing. In order to interpret toxicology findings it is necessary to reconcile test sensitivity, background biological variation, normal responses to inhaled materials and drug or medicine-specific adverse effects. Identification of adverse end-points is an area where better control data sets might help discern true adverse effects from a normal physiological lung response. The lung responds acutely to inhalation of irritant materials by hyper-secretion of mucus, chemokine release, inflammatory cell recruitment and cough and collectively these may be characterized as non-specific irritancy.

NCT ID: NCT01785641 Completed - Peritonitis Clinical Trials

Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

Start date: December 2012
Phase: N/A
Study type: Interventional

To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.

NCT ID: NCT01785472 Completed - Clinical trials for Essential Hypertension

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension

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

This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension

NCT ID: NCT01783444 Completed - Breast Cancer Clinical Trials

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

BOLERO-6
Start date: February 26, 2013
Phase: Phase 2
Study type: Interventional

This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.

NCT ID: NCT01782326 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study

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

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

NCT ID: NCT01780948 Completed - Clinical trials for Difference of 12-hour AUC

Pharmacokinetic of Everolimus and Atorvastatin Co-administration

Start date: September 2012
Phase: N/A
Study type: Interventional

Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.

NCT ID: NCT01780831 Completed - HIV Infections Clinical Trials

Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection

Start date: January 28, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of raltegravir (RAL) when given to HIV-1-exposed, normal birth weight newborn infants at risk of acquiring HIV-1 infection. (PK is the study of the time course of absorption, distribution, metabolism, and excretion of drugs in the body.) The primary goal of this study was to determine a dose of RAL that was safe and met the PK targets for infants when administered during the first 6 weeks of life in addition to standard of care antiretroviral (ARV) agents for prevention of perinatal transmission.

NCT ID: NCT01780753 Completed - Vivax Malaria Clinical Trials

Primaquine Pharmacokinetics in Lactating Women and Their Infants

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

The weight of malaria falls most heavily on young children and pregnant women but studies of the safety of antimalarials in pregnancy and lactation are few. The only recommended medication used for radical treatment of P.vivax is primaquine. The 2010 WHO malaria guidelines recommend its use in all patients with P.vivax infection in areas of low transmission, in the absence of contraindications. Primaquine is contraindicated in pregnancy. The postpartum period presents a key opportunity to definitively treat women who suffer multiple malaria relapses during pregnancy. The 2010 WHO malaria treatment guidelines allow for primaquine use during lactation but there are no studies to date quantifying primaquine excretion in breast milk and the dose that breastfed infants would be exposed to is unknown. The investigators propose to study the pharmacokinetics of primaquine in maternal and infant plasma and in breast milk during a 14 day radical treatment of P.vivax. Some inferences about the expected behavior of primaquine in lactation can be drawn from its known pharmacologic properties. Primaquine pharmacokinetics have been well characterized in healthy subjects and malaria patients after single and multiple oral dosing. Peak concentrations are reached within 2-3 hours after dosing and the plasma elimination half-life is ~7 hours. It is extensively distributed in the tissue and largely metabolized to inert carboxyprimaquine, the major plasma metabolite, which undergoes further biotransformation to unknown metabolites that are probably more toxic than the parent compound. The identification of other metabolites in humans has been difficult to pursue because the expected aminophenol metabolites are unstable. No pharmacokinetic studies have been done to measure primaquine excretion in breast milk. A few studies have been done of other antimalarials during lactation and have shown low levels of drug in breast milk during treatment.