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MCLNO, Charity Hospital Obstetrics Clinics. At the time of the scheduled
examination, a questionnaire concerning demographic, obstetric, sexual and
contraceptive history will be filled out. During the pelvic examination, swabs
of the cervical os (opening) and vuvlo-vaginal area will be taken. This is
followed by a 5cc rinse of the cervical os with sterile saline. Finally, a
single 10 ml (2-3 teaspoons) serum sample will be collected. This will take
approximately 10 minutes.
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HPV Sentinel Surveillance (HSS): Sentinel
Surveillance for Cervical Human Papillomavirus Infection among Women in the US
PURPOSE OF THE STUDY: The subjects are being
asked to participate in a research study to learn more about how many women in
the U.S. are infected with genital human papillomavirus infection (HPV). This
study is being done with the help of the Centers for Disease Control and
Prevention (CDC) at clinics in the Louisiana Health system and also clinics in
five other cities in the U.S. This study will include about 2000 women in New
Orleans and over 10000 women in total in all 6 cities.
Genital HPV is a
virus that is transmitted through sex. HPV is one of the most common sexually
transmitted diseases (STD) in the US. It is an important infection because it
can cause abnormal Pap smears and cancer of the cervix in women. There are many
different strains or "types" of genital HPV. Some are called "high-risk HPV"
because they increase the risk of getting cancer of the cervix. However, most
women who have infection with high-risk HPV do not know that they have the
infection and don't develop any important medical problems at all, especially if
they get regular Pap smears.
Because high-risk HPV can cause cervical
cancer, it is important to find out how widespread it is. This study is being
done to find out more about how many women in the US are infected with high-risk
HPV, and what things increase a woman's chance of having this infection.
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Prevention of Cervical Dysplasia by Detection of HPV
DNA:
PURPOSE OF THE STUDY: The subjects are being
asked to participate in a research study to improve the ability to detect
infection with human papillomavirus (HPV). HPV causes genital warts and cancers
of the cervix, penis and rectum. This purpose of this study is to examine the
different types of HPV infection at 5 regions of the Office of Public Health
that differ in their abnormal Pap smear and cervical cancer rates. HPV infection
will be determined from the cervical and urine specimens. It is hoped that a
less invasive test (urine) can be developed to detect HPV.
DESCRIPTION OF THE STUDY: Women between the
ages of 18 and 65 attending the Family Planning Clinics run by the Office of
Public Health from the Baton Rouge, Monroe, New Orleans, Alexandria, and
Shreveport regions (500 women per site for a total of 2500) of Louisiana who are
scheduled for pelvic examination will be asked to participate. This will include
at least 100 women per site who have been found to have an ASCUS or LGSIL Pap
smear diagnosis. Subjects who have an unstable medical condition such as
malignancy, severe asthma, unstable diabetes, etc. will be excluded from this
study. Subjects who are menstruating with be asked to return to the clinic after
menses for collection of specimens. HPV prevalence rates and the HPV genotype
will be determined and compared between regions as well as to simultaneous
collected demographic data.
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Prevalence of HPV in HIV- and HIV+ women:
PURPOSE OF THE STUDY: The subjects are being
asked to participate in a research study to better understand the prevalence of
human papillomavirus infection (HPV) in the community. HPV causes genital warts
and cancers of the cervix, penis and rectum. Many women are infected with these
viruses, but few progress to disease such as genital warts or cancer. This study
is designed to test who is infected with HPV. Those who are infected with HPV
will be asked to participate in another study designed to understand the body's
immune response to this virus. A better understanding of the immune response
against HPV may aid in the future development of both treatments and vaccines.
DESCRIPTION OF THE STUDY: A total of 500
HIV-seropositive female subjects will be recruited from the HIV Outpatient
Program (HOP) at LSUMC and 1500 HIV-seronegative female subjects from the LSU,
Charity Hospital Outpatient Clinics and the Orleans Parish Family Planning
Clinic. Upon consent to the study, a brief medical history will be taken. The
subject will undergo a Pelvic examination at which time she will be examined for
evidence of any sexually transmitted diseases. In addition, a dacron swab of the
cervix and vagina and urine sample will be collected for the detection of the
elements of the human papillomavirus. A self-administered vaginal specimen will
also be collected by placing two cotton swabs held together about two inches
into the vagina and rotating 360°(1 full turn). Women who have elements of the
HPV on the cervix or vagina will have the opportunity to participate in a more
extensive study of the body's immune response against HPV.
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Detection of HPV Infection in the Oral Cavity of HIV+ Men
and Women:
PURPOSE OF THE STUDY: Human papillomavirus
(HPV) can cause growths (warts) in the mouth and in the groin (genital) area.
The purpose of this study is to collect saliva to determine the prevalence rates
of HPV infection in the oral cavity. A better understanding of the growths
caused by HPV and how the body fights this infection may aid in development of
both therapies and vaccines against this virus.
DESCRIPTION OF THE STUDY: A total of 1000
men and women will be recruited from the HIV Outpatient Program (HOP) at LSUHSC.
All participants will be infected with HIV. After informed consent and answering
a few questions about previous genital infections and sexual partners, all
subjects will expectorate (spit) into a collection tube and collect 5-10 ccs (1
tablespoon) of saliva. This will be followed by a gentle swab and brush of the
inside of the cheek, the roof of the mouth, under the tongue, the tongue, and
the tonsils, if present. Finally, you will be asked to gargle with 5 ccs of a
salt solution and spit into a collection tube. The oral specimens will be tested
for HPV infection. The subjects may be eligible for a follow up study.
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A Pilot Study and Feasibility Evaluation of the Interrelationship Between Environmental and Genetic Factors in the Development of Squamous Cell Carcinoma (SCC) of the Head and Neck (SCCHN):
PURPOSE OF THE STUDY: Squamous cell carcinoma of the head and neck is a type of cancer that affects many people in Louisiana. This cancer has been linked to drinking and smoking. Louisiana has a higher rate of this cancer than the majority of the United States. Factors in addition to smoking and drinking may be involved and result in the higher head and neck cancer rate in our state. Other possible factors include diet, genes that make a protein that affects the body's use of the vitamins in the diet and a virus known as Human Papillomavirus, HPV. The purpose of this study is to collect dietary information as well as blood, saliva and tumor samples in order to see if these factors play a role in the development of this cancer.
DESCRIPTION OF THE STUDY: A total of 25 men and women with squamous cell cancer of the head and neck will be enrolled from the inpatient and outpatient services of the Medical Center of Louisiana, New Orleans. After informed consent, subjects who are enrolled will be asked a series of questions about their diet and smoking and drinking history. Subjects may be asked about sexual practices.Subjects undergoing either diagnostic biopsy or surgical removal of a tumor of the head and neck that is felt to be squamous cell carcinoma are eligible to enroll. After informed consent, the abnormal lesions and an area of similar surface type will be identified. These samples will: (1) be rubbed with a plastic (Dacron) swab, (2) be scraped with a brush (cytobrush) and (3) will have the growths entirely removed (excised) or a small piece removed (biopsied) depending on the size of the growth. The Head and Neck Surgeons will determine the best way to remove or biopsy tumor tissue. Levels of vitamins, changes in genes that may be related to dietary factors and the presence of HPV will be studied in the tissue samples. Blood will also be collected. Levels of vitamins, variations in a protein that affects the body's use of the vitamins, changes in genes that may be related to dietary factors and the presence of HPV will be studied in the blood samples. All subjects will also be asked to give 50-75 mls (5-8 tablespoons) of blood. The study will add approximately one hour to the visit. There are no planned follow up visits.
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Prevalence of Viral STDs in HIV+ and HIV- Individuals: Pilot Study in HIV+ Men
PURPOSE OF THE STUDY: You have been asked by your doctor to participate in a research study. The goal of this study is to determine possible improvements in the ability to detect infection with human papillomavirus (HPV) and herpes simplex virus type 2 (HSV2). HPV is the wart virus but can also cause cancer in the genital or anal tract. HSV2 causes genital lesions and ulcerations of the genital area and the skin surrounding the anus. This study is designed to compare patients with detected HSV or HPV to those without infection in respect to general health status and other infections like HIV. Swabs will be taken from different regions in the genital area and processed for detection of these viruses. These swabs are hoped to be more sensitive and more accurate. They are also less invasive than a blood draw, although some people might feel uncomfortable with swabs of the urethra and the anus. There is also concern whether patients with both HSV2 and HIV1 infection have a less favorable course than patients with either infection alone.
DESCRIPTION OF THE STUDY: A total of 50 HIV+ men will be recruited from the HIV Outpatient Program (HOP) at LSUHSC. After informed consent, a short questionnaire dealing with questions concerning sexual history and history of sexually transmitted diseases will be administered. Some of these question deal with intimate details and they might make you feel uncomfortable. Next, warts or lesions found in the genital areas in men and women will be sampled by wetting a dacron applicator with sterile normal saline, and swabbing the affected areas. Urine will also be collected. Finally, if blood is going to be drawn on this office visit, then 10 cc (2-3 teaspoons) of blood will be taken to detect HPV and HSV antibodies. For men, the clinician will (1) use 2 new wet swabs and sweep 360° around the tip of the penis (coronal sulcus and glans penis), (2) use a new swab to sample the entire skin surface of the shaft of the penis, (3) use a new swab to sample the scrotum, (4) the clinician will insert a smaller calcium alginate swab into the urethra and (5) an anal and perianal swab will be taken.
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A Double-Blind, Randomized, Controlled, Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in the Prevention of Genital Herpes Disease in Young Women who are HSV-1 and -2 Seronegative:
PURPOSE OF THE STUDY: Herpes is a serious health problem and is one of the most common infections in humans. It is caused by a herpes simplex virus (HSV). Once infected, the herpes virus remains in your body (in the nervous system) for your entire life. Although many herpes infections show no symptoms at all, these infections can be a major source of stress and discomfort. The herpes virus produces small, irritating, (and sometimes painful), fluid-filled blisters on the skin and mucous membranes (for instances around the mouth, eyes and genital area). The symptoms are usually short-lived (2-3 weeks), but the virus may be reactivated (blister come back) at times of illness, physical or emotional stress, or by exposure to sunlight, certain foods or medications.
There are effective medicines against herpes which can decrease the symptoms associated with this disease; however, there is no cure for herpes simplex virus. Vaccines prevent disease by producing antibodies (substances made by your body to prevent infections) and cells that can fight the agent that causes the disease. This research is being done because currently, there is no effective vaccine for this disease. This investigational herpes vaccine has been tested already in about 7,400 subjects. Previous studies with this vaccine have shown that it protected nearly three-quarters of women against genital herpes disease. However, there is no evidence that the vaccine protected women who were infected with HSV-1 prior to vaccination. The vaccine is currently not licensed and is still considered as investigational.
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