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NCT ID: NCT00702182 Completed - Clinical trials for Non-Small Cell Lung Cancer

Study of Oral Vinorelbine and Erlotinib in Non-Small Cell Lung Cancer

Start date: April 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine) to be used with erlotinib in non-small cell lung cancer.

NCT ID: NCT00699998 Completed - Clinical trials for Acute Coronary Syndrome

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

TRILOGY ACS
Start date: June 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

NCT ID: NCT00699751 Completed - Bone Metastases Clinical Trials

A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

ALSYMPCA
Start date: June 2008
Phase: Phase 3
Study type: Interventional

ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.

NCT ID: NCT00698048 Completed - Sepsis Clinical Trials

Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock

VaCoSS
Start date: August 2008
Phase: N/A
Study type: Observational

Patients with severe infection can develop very low blood pressure. There are many mechanisms leading to this, and one of them appears to involve a hormone called vasopressin. In children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. One possibility is the difference in the production and/or response to vasopressin. Vasopressin has become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. The exact timing and dose is uncertain. In this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). Blood will need to be taken from patients without any sepsis so as to be able to compare the values in health and in sickness. The patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. The aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. The long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.

NCT ID: NCT00697502 Completed - Solid Tumors Clinical Trials

Study of Capecitabine In Patients With Solid Tumors

Start date: May 2007
Phase: Phase 1
Study type: Interventional

Hypothesis: Patients with TYMS 2R/2R or 2R/3R appear to be more sensitive to fluoropyrimidines, conferring a higher risk of grade 3-4 fluoropyrimidine related toxicity and a higher response rate compared with 3R/3R. The genotype 3R/3R is more common in East Asia and is associated with greater tolerability to fluoropyrimidine as measured by lower toxicity but also lower response rates. As sensitivity to fluoropyrimidine appears to be affected by TYMS genotype, we hypothesise that patients with TYMS 3R/3R are more tolerant to standard doses of capecitabine and require higher doses to overcome fluoropyrimidine resistance. We designed this study to develop TYMS genotype specific dosing of capecitabine. Aims: 1. To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks followed by one week rest period (intermittent schedule) in patients with the advanced/ and or metastatic cancer based on TYMS genotype. 2. To determine a suitable phase II dose of intermittent schedule capecitabine. 3. To determine the safety and toxicity of this regimen. 4. To perform plasma pharmacokinetics of capecitabine. 5. To determine the relationship between genes of relevance in the fluoropyrimidine pathway with pharmacokinetics and toxicity.

NCT ID: NCT00697437 Completed - Solid Tumors Clinical Trials

Effect of Ketoconazole Inhibition of CYP3A on Urinary Excretion of Docetaxel

Start date: October 2006
Phase: Phase 2
Study type: Interventional

Primary Objective: - To confirm if ketoconazole inhibition of CYP3A activity affects fractional excretion of docetaxel in the urine. Secondary Objective: - To compare the metabolite ratios of the major metabolites of docetaxel in the presence and absence of CYP3A inhibition.

NCT ID: NCT00695994 Completed - Breast Cancer Clinical Trials

The Effect of Docetaxel or Gemcitabine-based Chemotherapy in East Asian and Caucasian Patients

Start date: October 2006
Phase: Phase 2
Study type: Interventional

The aims of this study are: 1. to compare the toxicity profile and efficacy of gemcitabine/carboplatin or docetaxel in East Asian and Caucasian patients. 2. to determine the genotype distribution of genes involved in docetaxel and gemcitabine pathways in East Asian and Caucasian patients. 3. to evaluate the association between genotypes and 1. treatment toxicity 2. treatment efficacy 3. pharmacokinetics.

NCT ID: NCT00694109 Completed - Clinical trials for Hypercholesterolemia

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

Start date: April 2008
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.

NCT ID: NCT00693732 Completed - Clinical trials for Irritable Bowel Syndrome

Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)

Start date: February 2009
Phase: Phase 4
Study type: Interventional

Visceral and somatic hypersensitivity as evidence of central sensory sensitization occur in the majority of Irritable Bowel Syndrome (IBS) patients. We recently demonstrated abnormal endogenous pain modulation as a cause of the sensitization in IBS and identified the underlying dysfunctional neuromatrix using functional MR-imaging (fMRI). Endogenous pain mechanisms regulate, fine-tune and integrate sensory and homeostatic, including neuroendocrine, immune and autonomic nervous system processes. Specific measures of sensitization and endogenous pain modulation correlate with clinical measures of somatic and neuropathic pain, suggesting usefulness as surrogate markers for clinical pain outcomes. Validation of experimental measures as surrogate markers in IBS would provide a considerable advance in pathophysiological and therapeutic research in this pharmacoeconomically burdensome disease.

NCT ID: NCT00693407 Completed - Clinical trials for Functional Dyspepsia

Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation

Start date: September 2008
Phase: N/A
Study type: Interventional

Visceral hypersensitivity as evidence of central sensory sensitization is evident in many patients with functional disorders such as functional dyspepsia (FD) and irritable bowel syndrome (IBS). We recently demonstrated both somatic hypersensitivity and abnormal endogenous pain modulation in IBS, both of which indicate central sensitization as a crucial mechanism in IBS. Endogenous pain mechanisms regulate, fine-tune and integrate sensory and homeostatic, including neuroendocrine, immune, motor and autonomic nervous system processes. Hitherto, no studies have investigated the role endogenous pain modulation in FD. Abnormal modulation could explain several of the symptom complexes associated with FD and provide a rationale for exploration of new treatments. The current study was designed to 1. investigate the gastric sensitivity in FD patients and healthy controls during gastric capsaicin stimulation 2. assess the endogenous pain inhibitory modulation system in FD patients and healthy controls during heterotopic stimulation