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NCT ID: NCT00864253 Completed - Malignant Melanoma Clinical Trials

A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

Start date: April 23, 2009
Phase: Phase 3
Study type: Interventional

The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.

NCT ID: NCT00863681 Completed - Clinical trials for Hypertension, Pulmonary

BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

PATENT-2
Start date: March 12, 2009
Phase: Phase 3
Study type: Interventional

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

NCT ID: NCT00863655 Completed - Breast Cancer Clinical Trials

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

BOLERO-2
Start date: June 2009
Phase: Phase 3
Study type: Interventional

There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

NCT ID: NCT00863512 Completed - Lung Cancer Clinical Trials

Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

Start date: March 2009
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

NCT ID: NCT00863499 Active, not recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder

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

The aim of the iSPOT-A study is to: 1. identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and 2. identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder.

NCT ID: NCT00861614 Completed - Prostate Cancer Clinical Trials

Study of Immunotherapy to Treat Advanced Prostate Cancer

Start date: May 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

NCT ID: NCT00860652 Active, not recruiting - Prostate Cancer Clinical Trials

Radiotherapy - Adjuvant Versus Early Salvage

RAVES
Start date: March 3, 2009
Phase: N/A
Study type: Interventional

Radical prostatectomy (RP) is the most common curative approach offered to men with newly diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to improve cure rates, but what is not known is whether it should be given straight after the operation or only when there is a rising PSA after surgery indicating active cancer. Immediate RT may not benefit all men, and can cause serious side effects such as bladder and bowel problems and impotence. International lack of consensus on the optimal timing of RT has resulted in varied clinical practice. This phase 3 trial will compare the two approaches.

NCT ID: NCT00859391 Completed - Celiac Disease Clinical Trials

Effects of Gluten Digestion With ALV003

0801
Start date: May 2008
Phase: Phase 0
Study type: Observational

This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of gluten with ALV003 or with placebo when ingested by CD Subjects.

NCT ID: NCT00858936 Terminated - Clinical trials for Coronary Artery Bypass Surgery

Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery

Start date: May 2009
Phase: Phase 2
Study type: Interventional

This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during surgery. This study has 2 parts. Part 1 will first test 36 subjects at different doses (amount) of the study drug. There will be 6 different groups of 6 subjects each that will receive the study drug or a placebo. A placebo is a substance that will be prepared to look like the study drug but will contain no active ingredients. In Part 1, five subjects from each group will receive study drug (IK-1001) and one will receive a placebo. This first part of this study is also a dose (amount) escalation. This means that each group will be receiving a different dose of the study drug. The first group will receive the lowest dose, the second group will receive a slightly higher dose, and the third group a slightly higher dose until all six groups has been tested. You can not choose which group you will be in but prior to starting each new dose level, the data (information) from the previous dose level will have been reviewed by a group of qualified individuals to determine if it is safe to proceed to the next highest dose level. Part 2 will expand the study and will treat at least 158 (and up to 632) more subjects at a dose level that has been deemed safe from information collected from Part 1. Subjects in Part 2 of the study will have a 1 in 2 (50%) chance of receiving the study drug or placebo. Whether the subject gets study drug or the placebo will be randomly assigned (like the toss of a coin). The study drug or placebo will be given as an intravenous infusion (into the vein) for six hours while the subject is having their CABG surgery. The subjects will be followed up for 6 months after their CABG surgery.

NCT ID: NCT00858871 Completed - Clinical trials for Hepato Cellular Carcinoma (HCC)

First Line Hepato Cellular Carcinoma (HCC)

BRISK FL
Start date: May 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.