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A Phase II Study of Neoadjuvant Letrozole for Post-Menopausal Women with Estrogen Receptor Positive Ductal Carcinoma In Situ

Principal Investigator: Alexandra Thomas, MD

Participants in this research have ductal carcinoma in situ (DCIS), an early change in the breast that could become breast cancer in the future. DCIS cells are sensitive to hormones, and therefore may be treatable with anti-hormonal medications. Standard treatment for DCIS includes surgery to remove the DCIS cells from the breast, or surgery followed by radiation therapy. The purpose of this study is to test whether neoadjuvant (neoadjuvant means given before surgery) treatment with the aromatase inhibitor (anti-hormonal medication) letrozole has an effect, either good or bad, on the participants and on the DCIS.

Mammograms are the standard method of detecting and measuring DCIS. The researchers conducting this study would also like to learn more about whether Magnetic Resonance Imaging (MRI) may be better for evaluating and measuring DCIS, compared to mammograms. (An MRI scan is a radiology technique that produces images of the body using magnets, not X-rays.)

Approximately six people will take part in this study conducted by investigators at the University of Iowa. Approximately 106 women will take part in this study nationwide.

age group:18 to 99 years trial start date:May 15, 2013
Gender Preference:none Trial End Date: February 1, 2015
Contact Info:

Clarine Halvorsen, 319-356-3944

Keywords: breast ; cancer ; ductal carcinoma in situ (DCIS) ; IRB#201209811 ; letrozole ; thomas

Trans-MAPP Epidemiology and Phenotyping Study (EPS) of Pelvic Pain

Principal Investigator:Karl Kreder, MD

At-a-Glance 

UI study seeks participants with pelvic pain

Women age 18 and older with pelvic pain or discomfort associated with frequent urination or urgency to urinate, as well as adult women with pelvic pain from interstitial cystitis are invited to participate in a University of Iowa research study on the conditions. 

The study aims to help reveal what causes the conditions with the goal of improving diagnosis and treatment. However, the study itself does not include treatment. 

Both interstitial cystitis and painful bladder syndrome can cause pain or discomfort in the pelvis or lower abdomen and the need to urinate more often than normal. 

The study involves one visit to UI Hospitals and Clinics. This visit will last three to four hours. The visit includes blood, urine and DNA tests, and a pelvic exam. Participants also will take a pain test.

Women who are pregnant are not eligible to participate in the study.

The study tests are provided at no cost. Compensation is available. The study is funded by the National Institutes of Health.

For more information, contact Mary Eno, study coordinator, at 866-309-0834 or mary-eno@uiowa.edu.

age group:18 to 99 years trial start date:May 14, 2013
Gender Preference:female Trial End Date: June 21, 2013
Contact Info:

Mary Eno, RN, Research Associate

mary-eno@uiowa.edu or 866-309-0834 or 319-384-9265

Keywords: Enter keyword

A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed At Time of Radial Cystectomy For Muscle Invasive Urothelial Cancer

Principal Investigator: Daniel Vaena, MD

Participants in this research study have bladder cancer (also known as urothelial cancer) that is confined to the bladder but invades into the deep portion of the bladder and requires bladder removal with removal of the lymph nodes in the pelvis.

The purpose of this research study is to compare the effects, good and/or bad, of performing a standard lymph node removal versus an extended lymph node removal at the time that participants are having surgery to remove their bladders. The extended lymph node surgery removes additional lymph nodes that are farther away from the bladder than those removed during standard lymph node surgery. Lymph nodes are present throughout the body and function normally to fight infection. They may also trap cancer cells that spread from a tumor. This is also referred to as metastasis. It is important remove the lymph nodes near the bladder to determine if they contain bladder cancer cells that have spread beyond the bladder. While extended lymph node removal is done commonly at some centers it is still considered experimental since investigators do not know if the additional surgery improves outcome.

Approximately 6 people will take part in this study conducted by investigators at the University of Iowa.

age group:18 to 99 years trial start date:May 14, 2013
Gender Preference:none Trial End Date: May 1, 2015
Contact Info:

Clarine Halvorsen, 319-356-3944

Keywords: bladder ; cancer ; IRB#201304744 ; urothelial ; vaena

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer

Principal Investigator:Daniel Vaena, MD

Participants in this research study have prostate cancer that has spread and they are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days.

The purpose of this research study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone.  “Investigational” means that the drug has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of prostate cancer.  The combination of TAK-700 and standard hormone therapy is considered experimental (investigational).

Approximately 20 people will take part in this study conducted by investigators at the University of Iowa.  Approximately 1,636 people will take part in this study nationwide.

age group:18 to 99 years trial start date:May 10, 2013
Gender Preference:none Trial End Date: May 15, 2018
Contact Info:

Clarine Halvorsen, 319-356-3944

Keywords: cancer ; IRB#201304802 ; phase 3 ; phase III ; prostate ; TAK-700 ; vaena

Brain Connectivity in Adolescents

Principal Investigator: Beng Choon Ho

Adolescents between the ages of 13-16 with a first degree relative (full-sibling or biological parent) diagnosed with schizophrenia, schizoaffective or schizophreniform disorder are invited to participate in a research study investigating brain connectivity and development in teens conducted at the UI Department of Psychiatry. The study includes 2 MRI scans and requires 3 visits to the University of Iowa Hospitals and Clinics and 4 follow-up phone calls over a 3-year period. Compensation is available.  For more information, call Julie at (319) 384-6521 or teen-study@uiowa.edu or toll free 1-866-890-5972.

age group:13 to 16 years trial start date:May 8, 2013
Gender Preference:none Trial End Date: May 8, 2014
Contact Info:

teen-study@uiowa.edu

Keywords: addiction ; addictive disorders ; adolescence ; brain ; brain development ; maturation ; MRI scan ; pediatric ; psychiatry ; psychosis ; psychotic disorders ; substance use ; teen
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