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NCT ID: NCT00611650 Terminated - Lung Cancer Clinical Trials

Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia

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

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or former smokers with bronchial dysplasia. PURPOSE: This randomized phase II trial is studying the side effects and how well green tea extract works in treating current or former smokers with bronchial dysplasia.

NCT ID: NCT00610818 Terminated - Skin Rash Clinical Trials

Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation

Palifermin
Start date: July 2007
Phase: N/A
Study type: Observational

We are approaching you to participate in this study because you are taking Palifermin and the purpose of this study is to describe the effect of Palifermin on skin growth found on the body. Palifermin is a new synthetic growth factor (encourages skin cells to grow) specifically designed to protect the areas of the body (mouth and upper digestive tract) that are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these areas to grow and therefore protects patients from some serious side effects of chemotherapy. These include mucositis or inflammation of the lining of the mouth and other organs resulting in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract. Skin cells are also known to respond to these types of growth factors like Palifermin, but unfortunately no studies have been done that look specifically at the effect of this drug on pre-existing skin lesions or the development of new skin lesions. We will be asking you if you have noticed any change in moles or other skin lesions that you have, and if you have noticed any new lesions. We will also be doing a full physical examination of the skin at regular intervals during the study to document the appearance of any new lesions or change in pre-existing ones.

NCT ID: NCT00608894 Terminated - Clinical trials for Autoimmune Hepatitis

LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis

Start date: December 2007
Phase: Phase 2
Study type: Interventional

An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).

NCT ID: NCT00608140 Terminated - Heart Failure Clinical Trials

Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure

SMMART-HF
Start date: March 2008
Phase: Phase 3
Study type: Interventional

Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the heart. Improper functioning of the mitral valve disrupts the proper flow of blood through the body, resulting in shortness of breath and fatigue. When mild, MR may not pose a significant danger to a person's health, but severe MR may be associated with serious complications, such as heart failure, irregular heart rhythm, and high blood pressure. Although there are treatments for MR, including medication and surgery, more information is needed on the effectiveness of these treatments in people with significant MR. This study will compare the safety and effectiveness of corrective surgery added to optimal medical treatment (OMT) versus OMT alone in treating people with significant MR caused by an enlarged heart.

NCT ID: NCT00607464 Terminated - Clinical trials for Hypothermia in Premature Infants

Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room

HeLP
Start date: September 2004
Phase: N/A
Study type: Interventional

Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?

NCT ID: NCT00607256 Terminated - Fibromyalgia Clinical Trials

Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

Start date: October 20, 2007
Phase: Phase 3
Study type: Interventional

To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

NCT ID: NCT00603577 Terminated - Clinical trials for Colorectal Neoplasms

Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

XENON
Start date: January 2008
Phase: Phase 3
Study type: Interventional

Primary objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of PSN at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. Secondary objective: - To assess the effect of xaliproden on patient-reported outcomes using the FACT/GOG NTX-12 subscale. - To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months - To assess the effects of xaliproden on the time to complete recovery from PSN - To evaluate the safety profile of xaliproden

NCT ID: NCT00602745 Terminated - Neoplasm Metastasis Clinical Trials

S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

S-1 Pancreas
Start date: February 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

NCT ID: NCT00600691 Terminated - Hematuria Clinical Trials

The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

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

The purpose of our study is primarily to evaluate the effects of 5mg finasteride on hematuria and hematospermia commonly associated with prostate biopsies. We hypothesize that 5mg of finasteride daily for two weeks preceding TRUS prostate biopsy and one week following will reduce hematuria and hematospermia commonly seen as complications following prostate biopsy. We also hypothesize that reducing complications will decrease concern among subjects and make for a more tolerable overall procedure than compared with subjects treated with placebo.

NCT ID: NCT00598988 Terminated - Clinical trials for Infectious Mononucleosis

Acupuncture for Infectious Mononucleosis Trial

AIM
Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate feasibility issues related to conducting an acupuncture study in a population of adolescents and young adults with infectious mononucleosis. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).