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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

NCT ID: NCT00692770 Completed - Clinical trials for Carcinoma, Hepatocellular

Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

STORM
Start date: August 15, 2008
Phase: Phase 3
Study type: Interventional

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

NCT ID: NCT00691054 Completed - Pancreatic Cancer Clinical Trials

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Did Not Respond to First-Line Therapy With Gemcitabine

Start date: June 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.

NCT ID: NCT00690872 Recruiting - Clinical trials for Head and Neck Cancer

Gemcitabine and Carboplatin Followed By Laboratory-Treated T Lymphocytes in Treating Patients With Metastatic or Locally Recurrent Epstein-Barr Virus-Positive Nasopharyngeal Cancer

Start date: July 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's T lymphocytes that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and carboplatin together with laboratory-treated T lymphocytes works in treating patients with metastatic or locally recurrent Epstein-Barr virus-positive nasopharyngeal cancer.

NCT ID: NCT00690430 Completed - Clinical trials for Symptomatic Refractory Resistant Carcinoid Disease

Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

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

The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

NCT ID: NCT00687791 Recruiting - Cataract Clinical Trials

Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

Start date: December 2007
Phase: Phase 3
Study type: Interventional

The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.

NCT ID: NCT00687648 Recruiting - Breast Cancer Clinical Trials

Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

Start date: May 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole, letrozole, or exemestane may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving combination chemotherapy together with aromatase inhibitor therapy is more effective than combination chemotherapy alone in treating breast cancer. PURPOSE: This randomized phase II trial is studying giving cyclophosphamide, methotrexate, and prednisolone together with aromatase inhibitor therapy to see how well it works compared with cyclophosphamide, methotrexate, and prednisolone in treating postmenopausal women with metastatic breast cancer.

NCT ID: NCT00683306 Approved for marketing - Clinical trials for Non Small Cell Lung Cancer (NSCLC)

Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.