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Clinical Trials
 
This is a listing of Loyola University Health System clinical trials that are open and actively recruiting patients. Please click on the name of the trial for a brief description, eligibility requirements and contact information. All trials listed below have been approved by Loyola's IRB chairman for promotion on the LUHS web site.
 
A Study of a Device to replace the Heart's Aortic Valve
This study will help doctors study the clinical care of patients who undergo aortic valve replacement with a specific valve.

 
A Measure of Endothelial Function in Depressed Patients
The purpose of this study is to determine whether depressed individuals show signs of dysfuntion in the cells that line blood vessels.

 
Leukemia Relapse Trial
The goals of this study are: 1) To find out the effectiveness and side effects of the high dose combination chemotherapy treatment for all subjects on this study

2) To find out the effectiveness and side effects of higher dose vincristine compared to standard dose vincristine

 
 
Aortic aneurysm
VALOR II
The purpose of the study is to determine if the Valiant Thoracic Stent Graft System is a safe and effective treatment for patients with descending thoracic aortic aneurysms.

 
 
Aortic valve
Aortic Valve Surgery in Marfan Patients
The purpose of the trial is to collect information on how patients do after having surgery on their aortic valve and compare the results of those who had their valve replaced to those who had the valve repaired.

 
 
Arrhythmogenic right ventricular dysplasia
Multidisciplinary Study of Right Ventricular Dysplasia (ARVD)
This is a multidisciplinary, multicenter collaborative study to investigate the cardiac, clinical and genetic aspects of arrhythmogenic right ventricular dysplasia (ARVD). The primary goal is to identify 100 patients with definite ARVD and their family members. The study offers a substantial prospect of expanding the fund of clinical knowledge regarding ARVD and/or localizing the genetic mutation(s) responsible for this disorder.

 
 
Arteriovenous malformation
Unruptured arteriovenous malformations
The study will evaluate whether medical management or invasive therapy (endovascular procedures, neurosurgery or radiotherapy, alone or in combination) will reduce the risk of death or stroke due to excessive bleeding or the development of a small area of dead, deteriorating tissue caused by a lack of blood supply.

 
 
Bipolar I depression
Ziprasidone and Bipolar I Depression
The purpose of this study is to determine whether or not ziprasidone, a currently marketed drug, is effective in treating bipolar I depression.

 
 
Bladder cancer
Bladder cancer that is confined to the bladder and the P53 gene
The trial seeks to study a gene found in tumors called P53 and to determine if patients with normal P53 do better than patients with tumors containing an abnormal P53 gene.

 
 
Bladder, Painful
A Randomized Multicenter Clinical Trial to Evaluate a New Treatment for Painful Bladder Syndrome Among Newly Diagnosed Patients
The purpose of this study is to determine if drug and behavioral treatment of painful bladder syndrome is effective in patients who have not previously been treated for this problem.

 
 
Brain
Study for bleeding in the brain
The purpose is to evaluate dose administration of a clot buster known as rt-PA, which may be effective in reducing the amount of hematoma clot in a patient with an intraventricular hemorrhage.

 
 
Brain tumor
A Phase III trial comparing the standard dose of temozolomide with a more increased, longer lasting dose of temozlomide in patients with newly diagnosed glioblastoma
The purpose of this study is to determine whether increasing the duration of temozolomide treatment after radiation from five days out of 28 days (standard-dose schedule) to 21 days out of 28 days (dose-dense schedule) will further improve results.

 
 
Breast cancer
A Randomized Trial of Whole Breast Radiation vs. Partial Breast Radiation for Women
The purpose of this study is to see if partial breast irradiation is as good as or better than whole breast irradiation.

 
Study to Evaluate Celecoxib
The purpose of this research study is to see if the drug celecoxib affects breast tissue by reducing breast tissue thickness on mammogram and if it reduces the growth of breast cells on breast tissue biopsy.

 
Exemestane vs. placebo for postmenopausal women who are at high risk of developing breast cancer
The study is to determine whether exemestane will reduce the rate of breast cancer in women at high risk of developing breast cancer.

 
A randomized phase III study of whole breast radiation versus partial breast radiation for women with breast cancer
The purpose of this study is to see if partial breast irradiation is as good as or better than whole breast irradiation in keeping cancer from coming back in the breast.

 
SOFT Trial
The purpose of this study is to see if shutting down a woman's ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It also will test whether a newer hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. The side effects of these different treatments will be studied.

 
Hormone therapy with or without combination chemotherapy in treating women who have undergone surgery for node-negative breast cancer (The TAILORx Trial)
This study is trying to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX). The goal is to determine whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who meet the special test criteria.

 
Trial comparing zoledronate, clodronate and ibandronate in stage I to III breast cancer
This study is being done to find out if adding a drug (a bisphosphonate) to hormonal or chemotherapy will help prevent cancer from spreading to the bones.

 
Goserelin in preventing ovarian failure in women receiving chemotherapy for breast cancer
The research is being done to determine if supressing ovary function during chemotherapy can reduce the incidence of premature menopause, which often is caused during adjuvant chemotherapy for breast cancer.

 
A clinical trial comparing letrozole to placebo in patients who have already completed up to five years of an aromatase inhibitor
The purpose of this study is to determine whether or not continuing hormonal therapy with an aromatase inhibitor (AI), called letrozole, for five additional years after already taking five years of hormonal therapy can further reduce the chance of breast cancer returning.

 
Anastrozole with or without fulvestrant as first-line therapy in treating postmenopausal women with metastatic breast cancer
The purpose of this study is to determine how effective combining anastronzole with fulvestrant is compared to anastrozole alone in treating postmenopausal women with metastatic breast cancer.

 
Adjuvant doxorubicin, cyclophosphamide and paclitaxel in treating patients with breast cancer
Chemotherapy drugs use different ways to stop tumor cells from growing. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer. This study seeks to compare three different chemotherapy regimens and their long-term outcomes.

 
Chemotherapy treatment of extensive breast cancer using chemotherapy drugs and drugs that may enhance the ability of the chemotherapy to kill the cancer cells
To treat patients with advanced breast cancer using two chemotherapy drugs, Docetaxel and Vinorelbine. This trial also uses the drug, Filgrastim, which will help the bone marrow produce more blood cells so the patient is less likely to be open to infection. Additionally, the drug, Trastuzumab, is used and may help the chemotherapy drugs work more effectively in killing the cancer cells.

 
Chemotherapy for advanced breast cancer for 2 groups of patients (one group 70 years and older and one group of less than 60 years old)
The study seeks to determine if using the chemotherapy drug, Docetaxel, will have an effect on a tumor and improve the length of survival of patients who have breast cancer that has spread.

 
Administration of hormone therapy to suppress ovary function during chemotherapy after surgical removal of breast cancer.
The research is being done to determine if supressing ovary function during chemotherapy can reduce the incidence of premature menopause, which is often caused during adjuvant chemotherapy for breast cancer.

 
Breast Radiation Using Mammosite Brachytherapy (after breast conserving surgery)
The purpose is to test whether radiation to part of the breast using brachytherapy after the removal of cancer gives similar results to those obtained when the whole breast receives radiation therapy. The study seeks to assess safety of the mammosite device in this setting, including the quality of life.

 
 
Breast cancer prevention
MAP3/EXCEL Study
The MAP3/EXCEL study is one conducted by the National Cancer Institute of Canada(NCIC) to determine whether a medication (exemestane, an aromatase inhibitor) can prevent breast cancer in healthy post-menopausal women who have an increased risk for developing breast cancer.

 
 
Cancer, Cervical or Endometrial
A phase II study of radiation therapy to the pelvis with or without chemotherapy for patients diagnosed with endometrial or cervical cancer
The purpose of the study is to test whether the use of an advanced radiation therapy delivery technique called intensity-modulated radiation therapy (IMRT) can spare normal tissue, including small bowel and large bowel, from radiation. The research is being done to try to reduce radiation side effects (especially diarrhea) that occur with the standard radiation methods.

 
 
Carotid artherosclerosis
Carotid stent trial
The study seeks to compare the safety and effectiveness of carotid stenting to carotid endarterectomy in preventing stroke.

 
 
Carotid stenosis
Patient outcomes for asymptomatic moderate carotid stenosis without surgery
The purpose is to examine the outcome of patients with asymptomatic moderate carotid stenosis without surgery and better identify candidates that would get the greatest benefit from surgery.

 
 
Cervical disc disease
A Prospective Randomized Controlled Study of an Artifical Cervical Disc Versus Anterior Cervical Fusion of a Single Disc for Symptomatic Cervical Disc Disease
The purpose of this investigation is to evaluate the safety and effectiveness of the artificial cervical disc in the surgical treatment of patients with symptomatic cervical degenerative disc disease.

 
 
Continent urethra function
Function of the Urethra in Continent Women
Stress incontinence is a common subtype of urinary incontinence, which affects millions of American women. In fact, one out of nine American women will undergo surgical treatment for this condition with up to 30 percent of those women requiring a second surgery. Women develop stress incontinence because the nerves that control the muscle (urethral sphincter) that keeps urine in the bladder are injured. The muscle is no longer able to work, and the women lose control of their urine. Studies have shown that women with stress incontinence have poor nerve and muscle function in the urethral sphincter; however, we do not know how the nerve and muscle work in women who do not leak urine. In order to understand why some women leak we need a better understanding of what is ‘normal’.

 
 
Diabetes mellitus and coronary artery disease
FREEDOM Trial
The purpose of this study is to compare two different methods of treatment for patients with diabetes mellitus and coronary artery disease in more than one heart vessel. The study seeks to evaluate whether drug-eluding stenting is more or less effective than coronary artery bypass surgery (CABG).

 
 
Diarrhea
PAR-101 Cdiff
The cause of the patient's diarrhea may be the result of an infection caused by clostridium difficile (Cdiff). Participation in this research study will help compare the effectiveness and safety of the research study drug, called PAR 101, with another drug called vancomycin, in the treatment of clostridium difficile-associated diarrhea (CDAD).

 
 
Head and neck cancer
A study to treat surgically removed cancer of the head and neck using a chemotherapy drug in combination with radiation therapy
The purpose of the study is to find the best dose of the chemotherapy agent Docetaxel when given with radiation therapy after surgical removal of all visible head and neck cancer and to see how effective the treatment is on overall patient survival rates.

 
 
Heart and obesity
Risk reduction of cardiovascular events such as stroke and myocardial infarction (MI) in the abdominally obese
Abdominally obese patients may have a number of risk factors for stroke, MI or death such as diabetes, uncontrolled hypertension and elevated cholesterol levels. The study will investigate whether the study drug decreases these risks more than a placebo.

 
 
Heart transplant
Novartis RAD2310
The purpose of this study is to test the safety and effectiveness of Certican combined with Neoral in patients with new heart transplants. The study will compare this new regimen with a commonly used regimen, MMF plus Neoral.

 
 
Heart, blood flow to
Acute Coronary Syndrome (ACS) Study
The purpose of this research study is to evaluate an investigational drug (not yet approved by the Food and Drug Administration) that is widely available and used in Japan to see whether it can identify patients who have alterations to the heart’s metabolism of fatty acid. An alteration of fatty acid metabolism in the heart is mainly caused by changes of blood flow to and through portions of the heart. Changes in blood flow in the heart are most likely due to coronary artery disease.

 
 
Hip and knee replacement
Hip and Knee Replacement Clinical Outcomes
This project aims to collect short, intermediate and long-term data on the clinical and functional outcomes of patients after hip or knee replacement surgery.

 
A comparison of dosing times for giving Arixtra to prevent blood clots after knee and hip replacement surgery
The objective is to evaluate the protective effect of Arixtra, initiated either on the same day of surgery or on the next morning after surgery, on the incidence of blood clots in patients undergoing major orthopedic surgery of the lower extremities.

 
 
HIV
LEXIVA - Once-daily HIV Treatment
The purpose of this study is to compare the effects of a reduced dose of ritonavir (100mg) to the effects of the standard dose of ritonavir (200mg), both in combination with fosamprenavir for the treatment of HIV.

 
Aires Trial
This study compares two different ways to treat HIV-1 infection.

 
Abbott 802 Study
To measure the safety and effectiveness of once-a-day HIV medication.

 
 
Incontinence
TOMUS(Transobturator MidUrethral Sling)
Stress urinary incontinence (the accidental loss of urine, often, but not always, with exercise, sneezing, coughing or similar physical activities) happens because the urethra (the tube that connects to the bladder and controls urination and urine storage) is not working well. Two commonly performed techniques are used for this “minimally invasive sling procedure.

 
ATLAS - Ambulatory Treatments for Leakage Associated with Stress Incontinence
The purpose of this study is to compare three specific non-surgical treatments for women with stress urinary incontinence.

 
 
Incontinence, Urge
Allergan Botox for Idiopathic Overactive Bladder
The purpose of this study is to evaluate the safety and effectiveness of up to five different doses of Botox injections versus a placebo into the bladder muscle for people whose overactive bladder and urge incontinence is not the result of neurologic disease or neurologic injury and have not responded well to overactive bladder medications.

 
 
Kidney cancer
Trial of anticancer vaccine for renal cell cancer.
For people who have kidney cancer surgery is the standard treatment. In a number of patients, the tumor will come back. The purpose is to determine if treatment with a research drug vaccine can delay or prevent the return of the cancer.

 
 
Kidney cysts
Complex kidney cysts: Information on patients who develop them.
The purpose of the study is to collect information about complex renal cysts.

 
 
Kidney stones
Treatment considerations for kidney stones.
The study is to determine the best possible treatment for kidney stones.

 
 
Kidney transplantation
Self-Care and Outcomes Among Kidney Transplant Recipients
The purpose of this study is two-fold. One purpose is to understand how kidney transplant recipients manage their health, finances and anti-rejection medicines to survive with a kidney transplant.

Secondly, the study seeks to understand kidney recipients' perceptions of kidney rejection and how they managed their health, finances and anti-rejection medicines with a kidney transplant.

 
Self-Care and Outcomes Among Kidney Transplant Recipients
The purpose of the study is to examine kidney transplant recipients’ strategies for self-care, coping, and managing their health and finances.

 
 
Knee replacement
Knee Study
This study aims to determine whether a difference exists in the short-, medium- or long-term clinical outcomes for individuals undergoing total knee arthroplasty (replacement) using either a fixed or mobile bearing prosthesis.

 
 
Leg ulcer
Venous Leg Ulcers
The purpose of this study is to determine the medical costs associated with the treatment of venous leg ulcers, to determine the number of patients with venous leg ulcers that heal during a 12-week period and to see the impact of venous leg ulcers on your quality of life.

 
 
Lung cancer
A Treatment for Patients With Lung Cancer That Cannot Be Removed By Surgery Due to Extensive Disease.
The purpose of this study is to find out if a maintenance dose of ZD-1839 after chemotherapy and radiation therapy followed by additional chemotherapy will help patients with advanced lung cancer survive for a longer period of time.

 
 
Melanoma
Vaccine Trial for Melanoma Patients Whose Disease Has Metastasized (Stage IV).
The main purpose of the study is to determine the safety of the trial's experimental procedure and the maximum dose of the vaccine that a human can tolerate. A secondary purpose is to see if the experimental procedure causes the melanoma cancer to shrink.

 
 
Menopause
Hot Flash Study
Estradiol is a combination drug approved for the treatment of hot flashes and vaginal symptoms in postmenopausal women. This study drug contains two kinds of hormones, estrogen and progestin.

In this study, two different dose combinations of estrogen and progestin will be compared to a low-dose estrogen-only supplement and a placebo. The purpose of this research study is to determine the lowest effective doses of the hormones that are in the drug to treat symptoms of hot flashes in menopausal women.

 
 
Oral cancer
Early Detection of the Spread of Oral Cancer to the Neck Lymph Nodes
The purpose of the study is to determine if the spread of cancer to the neck lymph nodes can be detected with minimially invasive surgical techniques.

 
 
Osteoporosis
Quality of Life Questionnaire for People With a Shortage of Vitamin D
It is felt that a vitamin D shortage can change the quality of life among adults with osteopenia and osteoporosis by affecting their mood, mental status, muscle strength and general funtional ability.

 
The Use of Risedronate for Prevention of Bone Loss after Lung Transplant Surgery
The aim in this study is to determine whether risedronate with calcium and vitamin D will lead to a reduction in bone loss compared to taking calcium and vitamin D alone, in patients undergoing lung transplant surgery.

 
 
Prostate cancer
A phase III protocol of hormones and radiation vs. hormones, radiation and chemotherapy for localized, high-risk prostate cancer
The purpose of this study is to determine whether adding chemotherapy to the standard treatment for localized high-risk prostate cancer is more effective than the standard treatment by itself.

 
Emotions and coping with prostate cancer: A brief survey for patients and their families.
The study seeks to better understand the emotional changes that patients and their families go through when someone is diagnosed with prostate cancer.

 
Continous or intermittent hormone treatment for prostate cancer
The study seeks to determine the effectiveness of continuous vs. intermittent hormone treatment for prostate cancer.

 
Prostate cancer prevention trial using selenium chemoprevention for patients wtih high grade prostatic intra epithelial neoplasia (PIN) and no evidence of prostate cancer
The study seeks to determine if taking L-selenium can prevent prostate cancer in men who have no cancer diagnosis but who have a high grade prostatic intra epithelial neoplasia (PIN).

 
Comparison of treatments for prevention of prostate cancer recurrence.
The study seeks to determine whether continuous or intermittant androgen treatment works better at preventing a recurrence of prostate cancer.

 
Provenge Clinical Trial for Patients with Metastatic, Androgen-Independent Prostate Cancer
The purpose of the study is to determine the good and bad effects of a treatment - APC8015 - and to determine how often patients respond after treatment with APC8015. The study compares APC8015 to APC-Placebo (a patient's antigen-presenting cells that were not altered while in the laboratory) to determine whether APC8015 delays the time until the cancer progresses and the patient develops pain due to prostate cancer.

 
 
Psoriasis
Etanercept Psoriasis Registry
The purpose of this study is to continue to gather and evaluate information on the long-term safety of etanercept in a large number of patients with plaque psoriasis.

 
 
Shin bone fracture wounds
Immediate Versus Delayed Closure of Open Shin Bone (Tibia) Fracture Wounds: A Protocol for a Randomized, Prospective Multi-Center Study
The purpose of this study is to see if there is a difference in the incidence of infection in patients who have had a fractured shin bone (tibia) closed with stitches immediately following the first surgery, compared to the incidence occurring in patients whose wound is closed 48 hours after the first operation.

 
 
Spinal stenosis
Stabilization Device After Spinal Stenosis Surgery
This study will help determine the needs for a stabilization device after spinal stenosis surgery.

 
 
Stroke
ALIAS - Albumin in acute stroke
Many stroke studies have been performed looking for an effective treatment for patients who have suffered an acute ischemic stroke. Thus far, all have failed. This study seeks to determine the effectiveness of albumin versus placebo given intravaenously for stroke patients.

 
Neck artery blockage
Carotid artery occlusion can be a dangerous factor for TIA and stroke. The study will look at the outcome after brain artery/vein bypass surgery versus best medical therapy.

 
 
Stroke with heart defect
CLOSURE
The study seeks to determine if a hole in the heart, which may have caused the patient's stroke or TIA, is best treated with medication or with a device to close the defect.

 
 
Toxic epidermal necrolysis
Study Comparing Remicade(infliximab) vs. Standard Treatment in a Specific Toxic Drug/Skin Reaction
Toxic epidermal necrolysis is a severe drug-associated reaction in which the skin is a major organ that is affected. In response to certain medications, some patients' bodies produce too much of certain chemicals that injure their skin and other organs and can often times result in death. Despite best efforts, there are no proven ways to effectively treat this condition. The purpose of this study is to determine if blocking a certain chemical signal will improve patients' survival.

 
 
Varicose veins
Correlation among the anatomy of the leg superficial veins and the different patterns of varicosities in patients with chronic venous disease
The study seeks to correlate the anatomy of the leg superficial veins and the different patterns of varicosities in patients with chronic venous disease.

 
 

www.luhs.org - Maywood, IL
Last reviewed: May 9, 2008

 

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